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Cannabis Consultants

by NaturPro in Uncategorized Comments: 0

NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

There are a lot of things to consider when developing cannabis products or hiring a consultant.

  1. Whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.
  2. Scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.
  3. Inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.
  4. Experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

Cannabis Consultants and Experts in Innovation, Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in regulatory compliance, GMP and quality assurance on CBD, cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

Audits for GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence
cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for cultivation, processing and testing operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

CBD Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

CBD SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

CBD Quality Consultants and Experts 

by NaturPro in Uncategorized Comments: 0

In a world where everyone claims to be an expert, NaturPro Scientific stands out as consultants who work for our clients.

Our history: We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

Our experience: There are a lot of things to consider when developing cannabis products or hiring a consultant.

First, is whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.

Second, is scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.

Third, is inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement, CBD and cannabis  industry as someone you can trust.

Fourth — is experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

CBD Quality Consultants and Experts Specializing in Innovation and Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on CBD, cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence
cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for CBD processing operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

CBD Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

CBD SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

Cannabis Quality Consultants

by NaturPro in Uncategorized Comments: 0

In a world where everyone claims to be an expert, NaturPro Scientific stands out as consultants who work for our clients.

Our history. We have more than 30 years experience in developing the scientific aspects of botanical products to support human health. So when we started to work on cannabis, hemp and CBD products in 2013, it was second nature.

Our experience: There are a lot of things to consider when developing cannabis products or hiring a consultant.

First, is whether your partners understand regulations, compliance and quality assurance, and how to balance these with business. We help you meet the legal requirements and regulations, without breaking the bank.

Second, is scientific expertise and experience across all the function platforms of health product businesses. Whether it’s the science, regulations, communications, validation or due diligence needed, you need someone who’s going to share expert opinions with honesty and transparency.

Third, is inside knowledge of industry standards through active participation on committees of industry standards-setting organizations like American Herbal Products Association, ASTM International and the U.S. Hemp Roundtable. We have a solid reputation in the food, supplement and cannabis  industry as someone you can trust.

Fourth — is experience consulting and working efficiently with companies of all sizes and types. Our clients ultimately value our knowledge of both the ideal and the practical, and helping to bridge the gap between efficiently and cost effectively.

Contact us today to learn more about how our expert consultants can help drive your cannabis firm and products to groundbreaking innovation, compliance and success.

——————-

Cannabis Quality Consultants Specializing in Innovation and Product Development and Regulatory Compliance

——————-

Quick Links:

——————–

 

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD and Cannabis Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence
cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

 

Standard operating procedures (SOP) for Cannabis operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

CBD and Cannabis Audits, GMP and Quality

by NaturPro in Quality Comments: 0

NaturPro Scientific is a recognized leader in audits, GMP and quality assurance on cannabis, botanical drugs, dietary supplements and foods.

What are Good Manufacturing Practices?  Good Manufacturing Practices (GMP) ensures products are consistently produced and controlled to the quality standards and conform to all applicable regulatory requirements.  Good Manufacturing Practices are fundamental to any manufacturing industry and are often required to be implemented in plants and factories by national governments.  Our team of experts can assist you with the development and evaluation of GMP programs  for cannabis, marijuana, hemp and CBD products.

We help you to train qualified staff, get in-depth and correct understanding of standards, and establish comprehensive management systems.

CBD and Cannabis Auditors, GMP and Quality Assurance

Here are some of the services we offer for cannabis compliance:

  • Audits
    • Preliminary Gap Analysis
    • Facility GMP pre-audits
    • Internal Audits
    • Third-Party Audits
    • CAPA Audits
  • Quality Management
  • Materials Testing
  • Process Approvals
  • Documentation and SOP
    1. Quality Manual
    2. Recordkeeping
    3. Document Control
    4. Traceability & Recall
      1. Formula Records
      2. Batch Records
      3. Certificates of Analysis
    5. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
    6. Supplier Qualification
    7. Preventive Controls
    8. Product Approval & Rejection, Material Inspection
    9. Complaints & CAPA (Corrective Actions)
    10. Quality Issue Investigation and Resolution
  • Training and Hiring
  • Investor Due Diligence
cannabis-consultants-extraction-GMP

NaturPro Scientific are cannabis consultants for extraction and GMP

NaturPro works closely with our clients to provide the most cost effective way to achieve GMP certification and an edge in the market.

The 4 main benefits of our audits (among many) include:

  1. Understanding where you are may not meet regulatory requirements
  2. Provide reviews and recommendations from a fresh perspective
  3. Train your staff on dealing with regulatory audits
  4. Reduce the risk of a food safety issue or costly product recall.

Audits are an integral part of the licensing and ongoing regulatory compliance process for cannabis, marijuana and CBD products. Cannabis audits can be rigorous, and are seen as a true ‘stress test’ on your quality system.

Pre-License Audits
Prior to issuing a license (e.g.,  Cultivation, Processor, Retail), regulators may require demonstration  compliance with the relevant cannabis regulation, and to ensure implementation of critical regulatory requirements such as physical security requirements, recordkeeping and good production practices. Licensed cannabis firms are required to demonstrate regulatory compliance at these audits in order to achieve (and maintain) their license.

Introductory Audits

An introductory audit may be scheduled after the pre-licensing audit, when the licensee is ready to start production. NaturPro Scientific is often hired to participate in and support our clients before, during and after regulatory audits. This audit is conducted to verify compliance against regulations in addition to inventory control/activities.

GMP Audit 
This type of audit assesses compliance against established Good Manufacturing Process (GMP) guidelines. Our experts have extensive experience with GMP audits to assist cultivators and processors  identify gaps against the regulations/standards, and putting appropriate corrective and preventative actions in place.

Quality Assurance
NaturPro has FDA-trained food safety experts (PCQI) and chemists on staff, and we are often called to perform duties of a Quality Manager for our clients. We handle and interpret lab testing, support supply chain and supplier qualification based on best practices for cannabis and botanical drugs.

Cannabis and CBD Experts

by NaturPro in Uncategorized Comments: 0

NaturPro Scientific are natural product, cannabis and CBD experts, with over 30 years of experience.  Our experience includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis
  • Developed products with improved dose delivery methods including water soluble and precise cannabinoid ratio products

————-

What do CBD and Cannabis experts do?

We write SOP and provide expert guidance: 

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes. Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.

Our services for CBD, cannabis and hemp include:

  1. Regulatory Submissions and Licenses
  2. Standard Operating Procedures (SOP)
  3. Good Manufacturing Practices (GMP)
  4. Food Safety Programs
  5. Gap Analysis and Audits
  6. Extraction and Production Processes
  7. Lab Safety and Hazardous Materials Handling
  8. Advanced Formulations
  9. Supplier and Vendor Qualification
  10. New Product Development
  11. Analytical Test Method and Laboratory Development,
  12. Materials Testing & Certificates of Analysis
  13. Operations, Facilities, Staffing & Training
  14. Investor Due Diligence
  15. Risk Assessment, Prevention & Management

CBD SOP’s and Cannabis Procedures

by NaturPro in Quality Comments: 0

Standard operating procedures (SOP) for CBD and Cannabis operations can be challenging. NaturPro Scientific’s experience with SOP helps you get to your desired outcome quickly and efficiently.

Our experience in cannabis includes:

  • Currently serve on ASTM International and American Herbal Products Association (AHPA) Cannabis Committees
  • Supported the development of operating standards and wrote standard operating procedures (SOP) for Good Manufacturing Practices (GMP) for cannabis standards‐setting organization, currently under review by ASTM International
  • Currently serve as regulatory and quality assurance consultant for hemp industry and trade organizations
  • Founding member of new self regulatory organization for hemp and CBD products
  • Coordinated initial R&D, production, quality assurance and regulatory affairs for a cannabis startup with operations in Washington, Colorado and Nevada
  • Assisted in development of cannabis license applications in New York, Florida, California, Colorado and Louisiana
  • Established analytical testing standards and guidelines for potency and purity of cannabis products
  • Audited cannabis analytical laboratory data according to ISO 17025 standards
  • Developed in‐house formulas, materials lists, manufacturing processes, manufacturing records and operational guidelines for cannabis extract and finished product production
  • Developed R&D for and commercial processes for large‐scale extraction and purification of cannabinoids and terpenes from cannabis

Cannabis & Hemp Procedures and SOP (Standard Operating Procedures) are the central part of operations of any cultivation, extraction, processing, packaging or testing business. Startups who invest in solid standard operating procedures (SOP) find themselves several steps ahead, running efficiently, with well-trained staff, and don’t suffer any costly mistakes.

Cannabis SOP are required by each state where cannabis, marijuana or hemp are regulated.

Any cannabis, hemp, medical or adult-use (recreational) marijuana product is subject to a number of controls, from seed to shelf. NaturPro Scientific has supported a number of clients in the aim of providing safe, effective cannabis and hemp products to support human health.


  1. Cultivation or Processing
    1. Management
    2. Applicable Regulations
    3. Operations
    4. Training & Safety
    5. Hygiene
    6. Sanitation & Cleaning
    7. Farm or Facility
    8. Equipment
    9. Seeds and Propagation Materials
    10. Agricultural Inputs
    11. Pre-harvest practices
    12. Harvesting
    13. Post-harvest practices
    14. Drying & Milling
    15. Sampling
    16. Testing (Potency, purity, cannabinoids, microbiology, heavy metals, pesticides)
    17. Waste Management
  2. Quality Management Systems
    1. Product Quality Policy/Manual
    2. Recordkeeping
      1. Document Control
      2. Formula Records
      3. Batch Records
      4. Certificates of Analysis
    3. Traceability & Recall
    4. Risk Analysis
      1. Hazard Analysis
      2. Purchasing Criteria & Specifications
      3. Supplier Qualification
      4. Intentional Adulteration
      5. Preventive Controls
    5. Product Approval & Rejection, Material Inspection
    6. Complaints & CAPA (Corrective Actions)

———————

The following information is a partial excerpt from draft from U.S. Hemp Roundtable guidance for CBD products, which NaturPro was fortunate to contribute to.

CBD SOP’s and Cannabis Procedures

U.S. Hemp Guidance Program PHASE 2

1 GROWER
1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains “any poisonous or deleterious substance which may render it injurious to health…..or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is”.

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp
Ingredient means any substance that is used in the manufacture of hemp and that is intended to

be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

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U.S. Hemp Guidance Program PHASE 2

quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

Microorganisms means yeasts, molds, bacteria, viruses, toxins, and other similar microscopic organisms which may or may not have a health or sanitary concern.

Pest means any objectionable insect or other animal including but not limited to birds, rodents, flies, mites, and larvae.

Physical plant or facility means all or any part of a building or facility used for or in connection with manufacturing, processing packaging, labeling, or storage of industrial hemp products or ingredients.

Processor means making a transformative change to the hemp plant or product following harvest.

Product complaint means any communication that contains any allegation, written, electronic, or oral, expressing concern, which may or may not have be related to the quality of an industrial hemp product.

Quality means that the hemp product meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.

Quality Management Systems means a planned and systematic operation or procedure for ensuring the quality of a hemp product.

Quality Management Systems personnel means any person, persons, or group, within or outside the organization, designated to be responsible for quality control operations.

Representative sample means a sample with an adequate number of units that are intended to ensure that the sample accurately portrays the material being sampled.

Reserve sample means a representative sample of product that is held for a designated period of time.

Sanitize means to adequately treat cleaned equipment, containers, utensils, etc.by a process that is effective in destroying of microorganisms of public health concerns.

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U.S. Hemp Guidance Program PHASE 2

1.2 REGISTRATION/APPLICATION/NOTIFICATION

Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)

1.2.1 Registration/Application Guidance

  • Name of the person or corporation to whom the license or authorization is to be issued
  • Address of the farm or place including county and township or legal description
  • The number of acres
  • Global Positioning System coordinates
  • Intended purpos of industrial hemp
  • In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and

o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.

o Specify if the hemp is for food or non-food purposes

1.2.2 Notification of Changes to the licensor by the licensee

Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:

  • Corporate name or ownership, or officers, and the replacement of an officer, or director
  • Any change to the address of the licensee
  • The replacement of an individual referred to a licensee
  • Any change in the mailing address of the licensee
  • Any change in the ownership of the land used to cultivate industrial hemp
  • Any change to the approved cultivar being sown or, in the case of a plant breeder, to thevariety of industrial hemp being sown;
  • Any genetic modification.

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Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

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U.S. Hemp Guidance Program PHASE 2

1.3 PERSONNEL

Qualified employees who grow, manufacture, package, or label industrial hemp shall be qualified to do so, and those responsible for quality control or performing any quality control operations, must have the education, training, or experience to perform the assigned functions.

Supervisors shall be qualified by education, training, or experience to supervise.
Contamination Prevention and Hygienic measures shall be taken to exclude from any operations

any person who might be a source of microbial contamination.

Such measures shall include the following:

  • Exclude personnel from working in any operations that may have an illness, infection, open lesion, or any other abnormal source of contamination.
  • Instructing employees to notify their supervisor if there is a possibility that they have a health condition described above.
  • Wearing outer garments in a manner that protects against the contamination.
  • Maintaining adequate personal cleanliness.
  • Washing hands thoroughly, and sanitizing if necessary, in a hand-washing facility.
  • Removing or covering all unsecured jewelry and other objects that might fall into components, industrial hemp, equipment, or packaging.
  • Using gloves when appropriate.
  • Wearing, where appropriate, hair nets, caps, beard covers, shoes, PPE etc.Personnel and employee safety measures shall include the following:
  • Appropriate and Adequate First Aid Equipment
  • Adequate bathrooms and changing rooms
  • Appropriate OSHA warnings, labels, and training
  • Appropriate training and personal protective equipment for pesticide application

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U.S. Hemp Guidance Program PHASE 2

1.3.1 U.S. HEMP GUIDANCE – GROWER – PERSONNEL CHECKLIST

√ ifApplicable

YES

NO

NOTES

Are the supervisors qualified for their responsibilities by training, education or experience?

Do the employees performing the growing, processing, packaging and labeling tasks, have the proper training necessary to perform the tasks?

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Are contamination and hygienic measures in place to exclude personnel who might be a source of contamination?

Are personnel excluded from operations if they have, an illness, infection, open lesion, or any other abnormal source of contamination?

Do employees notify their supervisor if there is a possible health condition as described above?

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Do personnel wear outer garments in a manner that protects against the contamination?

Do operating personnel maintain adequate personal cleanliness?

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Are hand washing facilities available and used?

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Do operating personnel remove or cover unsecured jewelry etc. to prevent them from falling into hemp products or causing harm?

Are gloves used when appropriate?

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Are caps, shoes and head covering used when appropriate?

Is the appropriate Personal Protective Equipment (PPE) used as needed?

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Are there adequate and appropriate first aid equipment available?

Is there adequate bathrooms and changing rooms?

Are the OSHA warnings and signs visible?

Has there been adequate training?

If applicable is the PPE and trains available for the pesticide applicators?

Signature: _____________________________ Date: ________________________ Printed Name: __________________________ Company/Location: ________________________

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U.S. Hemp Guidance Program PHASE 2

1.3.2 U.S. HEMP GUIDANCE – GROWER – BEST MANAGEMENT PRACTICES CHECKLIST

NOTES

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YES

NO

Are you using the best soil available?

Have you Soil tested for macro and micro nutrients?

Have you used the appropriate Growth Medium for intended purposes?

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Has the licensee determined the concentration of THC in the hemp?

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Is seed planted listed on the license?

Is the entire hemp plant used as licensed?

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Do you properly use pre- plant weed control?

Do you have a Germination Certificate from the seed supplier

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Did you use the proper Certified Seed suitable for location?

Did you use the proper seed treatment?

Do you have a site history?

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Do you have a water quality report or history?

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Did you use fertilizer to target desired yield per acre according to soil test?

Did you use animal manure for fertilizer or biomass purposes?

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Did you plant by optimum seeding date?

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Did you plant at the optimum rate of seeds per acre?

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Have samples of the industrial hemp been collected in accordance with the Guidance Procedures?

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Has the equipment used to sow, harvest and transport the hemp been thoroughly cleaned to prevent contamination?

Are you prepared to harvest when the plant is ready?

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Have you complied with the drying procedures

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Do you have sufficient and proper storage facilities or adequate transportation equipment available?

Is the biomass sold to a licensed person or entity according the Guidance Procedures?

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Is the biomass packaged, labeled, and transported according to the Transportation Guidance Procedures?

Has any loss or theft been reported according to the license requirements?

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Are the records being kept according to the Guidance Procedures for Record Retention?

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Grower Signature___________________________ Date _________________ Printed Name___________________ Farm location or identifier__________________

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U.S. Hemp Guidance Program PHASE 2

1.3.3 U.S. HEMP GUIDANCE – GROWER – FACILITY & BIOSECURITY AWARENESS CHECKLISTA.

√ ifApplicable

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Facility Security (physical security of buildings and grounds)

Is the facility using:

YES

NO

NOTES

Security lighting

Perimeter fencing

Controlled gate access

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Off-hours security guard

Electronic motion detectors

Door alarms

Video cameras

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Adequate indoor lighting

Alarms linked to an off-site security system

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Door hardware is of industrial design

Guards are installed on exterior ladders

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Exit doors and gate are electronically/mechanically secured

Entry and discharge points of exterior tanks are padlocked when not in use

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All vehicles parked outside are locked

Empty/loaded containers are parked inside

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Law enforcement patrol over company premises on regular but unpredictable basis

Employees reporting any suspicious behaviors

Restricted access to computer process control and data systems

Safeguard of data systems using data security program

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Backup of all data and processes at an off-site place

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B.

√ ifApplicable

Visitor Policy

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Is the facility using:

YES

NO

NOTES

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Company representative for visitor to check in with

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Signs informing visitors where to report

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Specific area for visitor parking

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Records of visitors (include name, company, arrival and departure, and purpose of visit)

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Visitor badges/identification cards

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Company representative to escort visitor all the time

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Restricted access to key manufacturing areas

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C.

√ ifApplicable

Distribution

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Is the facility implementing the following:

YES

NO

NOTES

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Bulk containers are inspected prior to loading for foreign and/or suspicious material

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U.S. Hemp Guidance Program PHASE 2

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Verify that all customer pick-up drivers are representatives of the customer

The product stream is inspected visually

Container access points are secured after loading

Seal numbers are documented on the shipping papers

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Shipping documents are used to identify the contents of each compartment

Shipping log is maintained

Bio-sanitation program is implemented

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Procedures exist to disinfect vehicles and drivers

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D.

√ if Applicable

E.

√ ifApplicable

Housekeeping

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Is the facility implementing the following:

YES

NO

NOTES

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Written housekeeping program for all areas of the facility

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Written pesticide and rodenticide program

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Emergency Response

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Is the facility implementing the following:

YES

NO

NOTES

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Employees are adequately trained to respond to a crisis as calmly and safely as possible

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Current inventory of all hazardous and flammable products

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A plan to provided MSDS to emergency response teams etc.

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A list of emergency contacts is posted

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An action plan to deal with suspicious devices or substances

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Evacuation plan in case of fire and explosions is published

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Establish and maintain an up-to-date employee roster and visitor log to facilitate personnel head count at any time

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Disaster Preparedness Plan

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A weapons security program

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Conduct evacuation and respond drill periodically

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Post a site plan depicting escape routes, fire-fighting and rescue equipment

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Signature: _____________________________
Printed Name: __________________________ Company: ________________________________

Date: ________________________________ Facility Location: ________________________________8

U.S. Hemp Guidance Program PHASE 2

1.4 SAMPLING AND HANDLING HEMP FOR THC & CBD1.4.1 Definitions

delta-9-THC means delta-9-tetrahydrocannabinol concentration.
Authority having jurisdiction usually means the state, but it could be FDA, USDA,

county or city.

Certified seed means seed for which a certificate or any other instrument has been issued, by an agency authorized under the laws of a state, territory, or possession to certify seed and which has standards and procedures approved by the United States Secretary of Agriculture to ensure the genetic purity and identity of the seed certified.

Plot means a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of hemp throughout the area.

ppm means parts per million.ppb means parts per billion.

Post-Harvest Sample means a sample taken from the harvested hemp materialfrom a particular plot’s harvest. The entire plot’s harvest must be in the same form(e.g., intact-plant, flowers, ground materials, etc.), homogenous, and not mixed with non-hemp materials or hemp materials from another plot.

Pre-Harvest Sample means a composite, representative portion from plants in a hemp plot collected in accordance with the procedures as defined by the state providing authority.

Processing means converting an agricultural commodity into a marketable form.Prohibited Variety means a variety or strain of cannabis excluded from the state

providing authority.

Sample means a sufficient amount of material that is representative of the population from which it is taken. A sample may be a particular plant part, including inflorescence (flower), leaf, stalk or seed, or it may be a processed product (oil, extract, powder. Samples must be dried to a sufficiently low moisture content so as not to harbor growth of microorganisms.

Seed source means the origin of the seed or propagules as determined by the state providing authority.

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U.S. Hemp Guidance Program PHASE 2

  1. 1.4.2  Sampling Timeline and Grower Responsibilities
    1. The grower shall refer to the jurisdiction having authority to determine a timeline.
    2. During the sampling, the grower or an authorized representative shall be present at the growing site.
    3. Floral materials harvested for phytocannabinoid extraction shall not be moved beyond the processor, nor commingled, nor extracted, until test results are complete
  2. 1.4.3  Pre-Harvest Sampling Procedure
    1. Adequate personal protective equipment shall be used.
    2. Proper equipment shall be used to prevent cross contamination.
    3. The material selected for Pre-Harvest Sampling will be determined by the grower. Cuttings will be collected to make one representative sample.
    4. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
      1. Clip the top 12 inches of hemp plant’s primary stem, including female floralmaterial.
      2. Take cuttings from at least five (5) hemp plants within the plot.
      3. Place the complete sample in a paper bag.
      4. Seal the bag by folding over the top once and staple the bag shut.
      5. A separate sample must be taken from each non-contiguous plot of a given variety.
      6. A separate sample must be taken for each variety.
      7. Samples shall be secured in a paper bag (to allow for air-drying during transport).
      8. Label the sample container with a sample ID.
  3. 1.4.4  Handling Procedures of Pre-Harvest Samples
    1. Samples will be taken for drying and storage.
    2. Samples should be arranged in a single layer for drying.
    3. Drying oven will be used when possible.
    4. Samples in the oven will be left in the labeled sample bag.
    5. If selected for testing, the entire sample will be sent to a testing lab for analysis.
  4. 1.4.5  Post-Harvest Sampling Procedures for Floral Material
    1. Refer to the authority having jurisdiction to determine adequate number of samples and proper locations. In the absence of jurisdictional requirements, the following guidance is given.
    2. Adequate personal protective equipment shall be used.
    3. Proper equipment shall be used to prevent cross contamination
    4. The plot selected for sampling shall be designated by the Pre-Harvest Sampleresults. The material selected for Post-Harvest Sampling from this plot will be

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U.S. Hemp Guidance Program PHASE 2

determined by the grower. All Post-Harvest Samples of floral material shall be taken from the designated harvested plot materials in the form (intact-plant, flowers, ground materials, etc.) in which the material will be sent to the processor

e. Grower must inventory the entire harvest to determine the form in which it exists and follow the protocol as appropriate in part a), b), or c) below.

  1. If, upon inventory, the grower determines that the entire harvest is not in a homogenous form (intact-plant, flowers, ground materials, etc.), it must be determined to take additional samples or other course of action or take the pre-harvest results.
  2. For intact-plant post-harvest samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., intact-plants).
    2. Clip the top 12 inches) of hemp plant, primary stem, includingfemale floral material.
    3. Take cuttings from at least five (5) non-adjacent hemp plantswithin the harvest’s storage/drying area.
    4. Place the complete sample in a paper bag.
    5. Seal the paper bag by folding over top once and stapling to keep closed.
    6. Complete sampling procedures in part (d) –(f).
  3. For ground plant or ground floral material Post-Harvest Samples:
    1. Ensure that the entire harvest is accounted for and in the sameform (i.e., all harvested material whether whole plant or floral material only must be ground with no intact plants or whole flowers remaining from that harvest).
    2. Sample material from bag or container.
    3. Sample from a minimum of four locations within the containers from a given harvest.
    4. Place the complete sample in a plastic sample container.
    5. Seal the plastic sample container.
    6. Complete sampling procedures in part (d) –(f).
  4. For Post-Harvest Samples in other forms (e.g., trimmed floral material, or floral material and stems, etc.):
    1. Ensure that the entire harvest is accounted for and in the same form (i.e., all harvested material must be uniform).
    2. Randomly collect at least one cup of material by volume.
    3. Place the complete sample in a paper bag or plastic containerand seal the container, as appropriate.
    4. Complete sampling procedures in part (d) –(f).
  5. A separate sample must be taken for each plot designated for Post-Harvest Sampling.
  6. Samples shall be labeled and prepared for transport to the lab.
  7. Label the sample container with a sample ID.

11

U.S. Hemp Guidance Program PHASE 2

1.4.6 Handling Procedures of Post-Harvest Samples

  1. The entire sample will be sent to the testing lab for analysis.
  2. Industrial hemp crops generated from Certified seed will incur pre-harvest testing of at least five percent (5%) of growing plots per variety, per seed source.
  3. Industrial hemp crops from planting materials other than Certified seed will incur pre- harvest testing of at least fifty percent (50%) of growing plots per variety, per seed source.
  4. 100% of post-harvest samples will be tested.

Tainted Supplements Perspective & A Master List of Offenders

by NaturPro in Quality Comments: 0

On Tainted Supplements: A Perspective and Recommendation, with a Working List
 of Recent FDA Actions on Drugs Labeled as Dietary Supplements.

Dietary supplement adulteration from 2007-2016 was relatively infrequent compared to instances of food adulteration, and issues of adulteration were from drugs labeled as supplements, according to October 2018 article in JAMA.

According to one estimate based on the JAMA study and industry volume data from Nutrition Business Journal, approximately one bottle of dietary supplements may be adulterated for every 9,000 sold in the U.S.

Supplements as a subset of food comprises less than 5% of all adulterated food imports. When combined with cases of domestic adulteration and confirmed food poisoning caused by adulteration of fruits, vegetables and meat with pathogens like Salmonella, supplements comprise far less than 1% of documented adulteration.

The most interesting part of the JAMA study, is that about 98% of supplement adulteration are for drug spiking of products sold in only 3 sub-markets:  weight loss, men’s sexual health and bodybuilding products. Only 13 adulterated products were noted for the rest of the industry, suggesting that the issue is not as far-reaching as many assume.

The issue of ‘drugs masquerading as supplements’ is a global one affecting many countries, and not just the U.S. Spiking of dietary supplements or foods with drugs is not only unsafe, but it’s also illegal and can (and should) lead to jail time.

While we have compiled a partial list of product names of mislabeled drugs (below),  the offenders in the U.S. often remain anonymous, and don’t have their name, address or company name listed for industry and consumers to be aware of.

If you disagree with the policy of covering up the identity of ‘bad actors’, or you suspect possible drug-spiking in weight loss, bodybuilding or sexual health products, you should report to FDA by email to TaintedProducts@fda.hhs.gov.  Please ask FDA to publish the names and addresses of all owners of all listed products.

If you have a symptom or health issue that you think may be caused by a drug, food or  supplement, contact your physician immediately. 

The information on this page is not intended to include every instance of adulterated or mislabeled products.  Source: www.KeepSupplementsClean.org accessed October 2018

 

UNITED STATES

Product Name
Company
Date
Action Taken
Nuvitra Company Unknown 08/13/18 Public Notification
Asunsa Company Unknown 07/09/18 Public Notification
Lyn DTOX FS3 Company Unknown 07/09/18 Public Notification
Platinum Maximum Strength Blue Pill Version, Slimming Plus Advanced Weight Loss, Lean Extreme Max, X-treme Beauty Slim, Meizitang Strong Version capsules, Magic Slim capsules, Slim Xtreme capsules, Meizi Evolution capsules, SlimEasy Herbs capsules, Super Fat Burning Bomb capsules, FRUTA Bio, JIANFEIJINDAN Activity Girl, Reduce Weight FRUTA PLANTA, Fat Loss Slimming Beauty, Fruta Planta, Botanical Slimming, Slim Body MyNicNaxs LLC 07/06/18 Voluntary Nationwide Recall
Adipotrim XT Company Unknown 07/03/18 Public Notification
Body Shape Weight Loss System Company Unknown 07/03/18 Public Notification
Row of Antibody Pil Company Unknown 07/03/18 Public Notification
Adriana Balance S Company Unknown 06/20/18 Public Notification
AB Slim Company Unknown 06/20/18 Public Notification
PAYA Dietary Supplement Product Company Unknown 06/07/18 Public Notification
Asia Slim Capsules Company Unknown 11/22/17 Public Notification
Fruta Planta Life (Garcinia Cambogia Premium) Company Unknown 11/20/17 Public Notification
Adipessum Miracle Slimming Capsules Company Unknown 11/20/17 Public Notification
A1 Slim Kiriko LLC 10/05/17 Voluntary Nationwide Recall
Atomic and Xplode Capsules EZ Weight Loss TX LLC 07/24/17 Voluntary Nationwide Recall
LaBri’s Body Health Atomic 60 Capsules Envy Me 03/28/17 Urgent Recall
Slimming Plus Advanced This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/03/17 Public Notification
Platinum Max Strength Blue Pill Version This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/03/17 Public Notification
Platinum Weight Loss Solution – Fat Loss Metabolizer This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/03/17 Public Notification
Lean Extreme Max This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/02/17 Public Notification
X-treme Beauty Slim This product is product promoted and sold for weight loss on various websites and possibly in some retail stores. 02/02/17 Public Notification
Queen Slimming Soft Gel This product is promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. 12/22/16 Public Notification
Ultimate Body Tox PRO This product is promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. 11/30/16 Nationwide Voluntary Recall
DMAA Net Weight 500g This product is purchased through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and wholesale. 11/23/16 Voluntary Recall
ABX Weight Loss This product is promoted and sold for weight loss on the Web site, www.zxtbeepollenpills.com, and possibly in some retail stores. 11/16/16 Public Notification
Supreme Slim 5.7 This product is promoted and sold for weight loss on various websites including www.absolutenaturalweightloss.net, and possibly in some retail stores. 11/09/16 Public Notification
Skinny Bee Diet The product is used as a weight loss dietary supplement and is packaged in white silver bottle with red capsules. The affected Skinny Bee Diet product includes bottles MFD: 03.07.2016 EXP: 03.06.2018 Love My Tru Body distributed Skinny Bee Diet capsules nationwide March 23 – April 28, 2016 to consumers via the internet www.lovemytrubody.com 11/08/16 Voluntary Nationwide Recall
Ultimate Body Tox This product is promoted and sold for weight loss on various websites including www.ultimatebodytox.com, and possibly in some retail stores. 11/07/16 Public Notification
Zi Su Body Fat Health II (紫苏瘦身营养素 II – Zi Su Shou Shen Ying Yang Su II) This product is promoted and sold for weight loss on various websites and in stores. 10/25/16 Public Notification
Results This product is promoted and sold for weight loss on various websites, including distributors via www.facebook.com, and possibly in some retail stores. 10/19/16 Public Notification
Accelerator Boost This product is promoted and sold for weight loss on various websites and in stores. 10/19/16 Public Notification
Skinny Bee Diet This product is promoted and sold for weight loss on various websites and in stores. 10/19/16 Public Notification
Adelganzantes R-II This product is promoted and sold for weight loss on various websites and in stores. 08/09/16 Public Notification
Ultimate Lean This product was promoted and sold for weight loss on various websites and possibly in some retail stores. 07/28/16 Public Notification
Zi Xiu Tang Beauty Face and Figure Capsule This product was promoted and sold for weight loss on various websites and possibly in some retail stores. 07/28/16 Public Notification
Slim Fit X This product was promoted and sold for energy weight loss on various websites. 07/27/16 Public Notification
Mang Luk Power Slim Detox Promoted and sold for weight loss on various websites. 07/27/16 Public Notification
Xcelerated Weight Loss Charged Up Promoted and sold for weight loss on various websites, including www.xceleratedweightloss.com, and possibly in some retail stores. 07/22/16 Public Notification
Xcelerated Weight Loss Turbo Charge Promoted and sold for weight loss on various websites, including www.xceleratedweightloss.com, and possibly in some retail stores 07/22/16 Public Notification
Xcelerated Weight Loss Ultra Max Promoted and sold for weight loss on various websites, including www.xceleratedweightloss.com, and possibly in some retail stores 07/22/16 Public Notification
Dream Body, Dream Body Extreme Gold and Dream Body Advanced Dream Body Weight Loss 07/01/16 Voluntary Nationwide Recall
Step 2 The Body Shot Bar 06/07/16 Voluntary Nationwide Recall
3rd Degree, Black Gold X Advanced, and Black Label X Making It A Lifestyle LLC 04/29/16 Voluntary Nationwide Recall
SUPER HERBS The affected Super Herbs product includes all bottles which have been distributed nationwide to consumers via internet www.mysuperherbs.comdisclaimer icon. 04/11/16 Voluntary Recall
Propell Platinum This product was promoted and sold for weight loss and energy on various websites and possibly in some retail stores. 03/29/16 Public Notification
ENVY BP This product was promoted and sold for weight loss on various websites, including www.purelysimpleweightloss.com, and possibly in some retail stores. 03/28/16 Public Notification
ZlimXter Capsules This product was promoted and sold for weight loss and energy on various websites and possibly in some retail stores. 03/17/16 Public Notification
Dynamizm Capsules This product was promoted and sold for weight loss on various websites and possibly in some retail stores. 03/17/16 Public Notification
Eradicate Capsules This product was promoted and sold for weight loss on various websites, including www.x2zero.com, and possibly in some retail stores. 03/17/16 Public Notification
Xerophagy Capsules This product is promoted and sold for weight loss on various websites and possibly in some retail stores. 03/17/16 Public Notification
Pink Bikini and Shorts on the Beach Capsules These products were distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store. 01/28/16 Voluntary Nationwide Recall
Thirty Plus Product promoted for weight loss on various websites, including www.getskinny.bigcartel.com, and in some retail stores. 12/17/15 Public Notification
Pink Bikini Lucy’s Weight Loss System. Product promoted for weight loss on the website and in some retail stores. 12/09/15 Voluntary Nationwide Recall
Lipo Escultura Product promoted and sold for weight loss on www.lipoesculturatreatment.com by JAT Productos Naturales Corp., but may also be distributed under the following aliases: Lipo Escultura Corporation and JAT Natural Products Corp. This product is also heavily promoted on the firm’s Facebook and Instagram accounts.Image of Lipo Escultura 12/02/15 Public Notification
Zero Fat Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
SPCARET Princess Diet Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
Slyn Both Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
Perfect Slim Fast Track Slim Product promoted for weight loss on the website and in some retail stores. 11/19/15 Public Notification
Super Herbs Product promoted for weight loss on the website, www.mysuperherbs.com, and in some retail stores. 11/19/15 Public Notification
Xtreme Fat Burner Capsules Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Tip-Top Shape Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Lishou Slimming Coffee Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Basha Nut 100% Fruit Soft Gel Capsules Product promoted and sold for weight loss on various websites. 10/23/15 Public Notification
Ultimate Herbal Slimcap Product promoted and sold for weight loss on various websites, including www.fitfirmandfabulous.com< 10/01/15 Public Notification
NATUREAL Product promoted and sold for weight loss on various websites, and possibly in some retail stores.< 10/01/15 Public Notification
Pink Bikini and Shorts on The Beach Lucy’s Weight Loss System 09/23/15 Voluntary Nationwide Recall
MIRACLE DIET 30 and MIRACLE ROCK 48 http://www.fda.gov/Safety/Recalls/ucm462131.htm< 09/11/15 Voluntary Nationwide Recall
Meizi Super Power Fruits Herbal Slimming Formula Product promoted and sold for weight loss on various websites, and possibly in some retail stores.< 09/03/15 Public Notification
Methyldrene Original 25 Methyldrene 08/24/15 Voluntary Recall
Black Widow 25 Black Widow 08/24/15 Voluntary Recall
Asia Black Asia Black 08/24/15 Voluntary Recall
Xcellerator Xcellerator 08/24/15 Voluntary Recall
Thin and Slim Naturally AM Thin and Slim Naturally 08/24/15 Voluntary Recall
Tru Trim Tru Trim 08/24/15 Voluntary Recall
Metabolic Accelerator Metabolic Accelerator 08/24/15 Voluntary Recall
ThermoFX ThermoFX 08/24/15 Voluntary Recall
Fataway Ultimate Stack, MaxOut Body, Burn Fat Now, Thermogenic Fat Burner, Extreme Stack Thin & Slim 08/24/15 Voluntary Recall
Kaboom Action Strips and Lida Daidaihua Blue Square Market 08/17/15 Nationwide Recall
Achieving Zero Blue Square Market 08/06/15 Public Notification
Akttive High Performance Fat Burner Gold Capsules Life & More LLC 07/23/15 Nationwide Recall
Smart Lipo (800, 900, 950 mg) capsules Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules – 9/15/2017, 900mg capsules – 7/30/2017, 950mg capsules – 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.comdisclaimer icon 06/03/15 Nationwide Recall
Li Da Dai Dai Hua Slimming Capsule Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/30/15 Public Notification
Slim Forte Slimming Capsule Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/30/15 Public Notification
Superior Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/29/15 Public Notification
Fatloss Slimming Beauty Product promoted and sold for weight loss on various websites, and possibly in some retail stores. 04/29/15 Public Notification
Slim Trim U, ZXT Slim Bee Pollen, Magic Slim, ZXT Bee Pollen, ZXT Gold Infinity, Lean Body Extreme, Bnew Beauty and Body and Natural Body Solutions Floyd Nutrition LLC 04/15/15 Consumer Warning
Ultimate Boost Product promoted and sold for weight loss on various websites, including www.sportnutrition1.com, and possibly in some retail stores. 03/18/15 Public Notification
Xcel Product promoted and sold on various websites including www.zixiutangforyourfigure.com and in some retail stores. 03/18/15 Public Notification
Xcel Advanced Product promoted and sold on various websites including www.beenaturalnutrition.com, and possibly in some retail stores. 03/18/15 Public Notification
Ultra ZX Product promoted and sold on various websites and in some retail stores. 03/10/15 Recall
L-Carnitine Sob Strengthening Version Slimming Miracle Capsule Product promoted and sold on various websites and in some retail stores. 03/05/15 Public Notification
Natural Max Slimming Product promoted and sold on various websites and in some retail stores. 03/03/15 Public Notification
Diablos Eca Fire Caps Product promoted and sold on various websites and in some retail stores. 03/03/15 Public Notification
Black Mamba Hyperrush Product promoted and sold on various websites and in some retail stores. 03/03/15 Public Notification
Elimulating Weight & Toxin Keeping Beauty Product promoted and sold on various websites and in some retail stores. 03/02/15 Public Notification
Nine Slim Product promoted for weight loss and sold on various websites and in some retail stores. 02/28/15 Public Notification
Oxy ELITE Pro Super Thermogenic Product promoted and sold on various websites and in some retail stores. 02/28/15 Public Notification
Seven Slim Product promoted and sold on various websites and in some retail stores. 02/28/15 Public Notification
Botanical Slimming (Red) Product promoted for weight loss and sold on various websites and in some retail stores. 02/27/15 Public Notification
Lean Body Extreme Product promoted for weight loss and sold on various websites and in some retail stores. 02/25/15 Public Notification
Yanhee Slim Product promoted for weight loss and sold on various websites and in some retail stores. 02/03/15 Public Notification
Slim-K Promoted and sold for weight loss on various websites including www.bethel30.com and possibly in some retail stores. 12/23/14 Public Notification
B-Lipo Capsules Promoted and sold for weight loss on various websites including www.bethel30.com and possibly in some retail stores. 12/23/14 Public Notification
SLIM-K Capsules Promoted and sold for weight loss on various websites and possibly in some retail stores. 12/19/14 Voluntary Recall
B-Lipo Capsules Promoted and sold for weight loss on various websites and possibly in some retail stores. 12/19/14 Voluntary Recall
Slim-Vie Promoted and sold for weight loss on various websites and possibly in some retail stores. 11/25/14 Public Notification
Bee Thin Promoted and sold for weight loss on various websites, including www.beethinzxt.com, and possibly in some retail stores. 11/24/14 Public Notification
Bee Slim Promoted and sold for weight loss on various websites, including www.alphaomegaherbs.com, and possibly in some retail stores. 11/24/14 Public Notification
Super Extreme Accelerator Promoted and sold for weight loss on various websites and in some retail stores. 11/24/14 Public Notification
V26 Slimming Coffee Promoted and sold for weight loss on various websites and in some retail stores 11/04/14 Public Notification
Sit and Slim II Promoted and sold for weight loss on various websites and in some retail stores 10/10/14 Public Notification
LX1 Promoted and sold for weight loss on various websites, including Dr. Skin Secrets, and possibly in some retail stores 09/23/14 Public Notification
Best Line Suplemento Alimenticio Capsules Product promoted for weight loss and sold on various websites and in some retail stores. 09/15/14 Public Notification
Mezo Product promoted for weight loss and sold on various websites and in some retail stores. 09/15/14 Public Notification
RegeneSlim Appetite Control Capsules Purchased by and distributed through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and retail sales. 08/07/14 Recall
24 Ince Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Trim-Fast Slimming Softgel Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Lingzhi Cleansed Slim Tea Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Lipo 8 Burn Slim Capsules Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Mix Fruit Slimming Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Sliming (sic) Diet By Pretty White Product promoted and sold on various websites and in some retail stores. 07/08/14 Public Notification
Toxin Discharged Tea Product promoted and sold on various websites and in some retail stores. 06/17/14 Public Notification
Sport Burner Product promoted and sold on various websites and in some retail stores. 06/17/14 Public Notification
Sliming Diet Product promoted and sold on various websites and in some retail stores. 06/17/14 Public Notification
La Jiao Shou Shen Product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com and in some retail stores. 06/10/14 Public Notification
Bangkok Pills Product promoted and sold on various websites and in some retail stores. 06/08/14 Consumer Warning
B-Perfect Product promoted and sold for weight loss on www.icanb-perfect.com and possibly sold in some retail stores. 06/05/14 Public Notification
Asset Bold Product promoted and sold on various websites and in some retail stores. 05/16/14 Public Notification
Asset Bee Pollen Product promoted and sold for weight loss on various websites, including www.assetcapsules4u.com, and in some retail stores. 05/12/14 Public Notification
African Black Ant, Black Ant, and Mojo Risen Eugene Oregon Inc. 05/05/14 Voluntary Recall
Slim Trim U Product promoted and sold for weight loss and sold on various websites and in some retail stores. 05/05/14 Public Notification
Natural Body Solution Product promoted and sold for weight loss and sold on various websites and in some retail stores. 05/05/14 Public Notification
LiteFit USA Bacai Inc. 04/29/14 Voluntary Recall
Zi Xiu Tang Bee Pollen Manufactured by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd. It is offered for sale on the Internet, and it can be found in various retail stores, spas and fitness centers. In addition, licensed health care professionals have promoted the product. 04/17/14 Consumer Warning
Lite Fit USA Product promoted and sold for weight loss on various websites, including www.herbsultimate.com, and in some retail stores. 04/10/14 Public Notification
Infinity Product promoted and sold for weight loss on various websites, and in some retail stores. 04/10/14 Public Notification
Thinogenics Products Nature’s Universe 04/09/14 Worldwide Recall
New You Product promoted and sold for weight loss and sold on various websites and in some retail stores. 04/02/14 Public Notification
Bella Vi Brand Pure Edge Nutrition LLC 03/26/14 Voluntary Nationwide Recall
Super Fat Burner, Maxi Gold and Esmeralda New Life Nutritional Center 03/25/14 Voluntary Nationwide Recall
Vitaccino Coffee Product promoted and sold on various websites and in some retail stores 03/19/14 Public Notification
Fat Burner HCA America Bysilver Pharmaceutical Co. 02/06/14 Consumer Warning
Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction MyNicKnaxs LLC 02/04/14 Voluntary Nationwide and International Recall
Reduce Weight Fruta Planta MyNicKnaxs LLC 02/04/14 Voluntary Nationwide and International Recall
Dr. Ming’s Chinese Capsule, Magic Slim, and Dream Body Slimming Capsule Slim Beauty USA 01/31/14 Warning Letter
Mega Slim Herbal Appetite Management YoungYou International 01/30/14 Voluntary Recall
Citrus Fit Gold Product promoted and sold for weight loss on various websites, including www.citrusfit.com, and in some retail stores. 01/28/14 Public Notification
Tonic Life BP Product promoted and sold for weight loss and sold on various websites, including www.tonic-life-products.com, and in some retail stores 01/28/14 Public Notification
Thinogenics Product promoted and sold for weight loss and sold on various websites, including www.easy2loseweight.com, and in some retail stores 01/28/14 Public Notification
Hot Detox Promoted and sold for weight loss and sold on various websites, including www.hotdetoxllc.com, and in some retail stores 01/28/14 Public Notification
Dream Body Slimming Capsule Product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com, and in some retail stores. 01/21/14 Public Notification
Magic Slim Product promoted and sold for weight loss and sold on various websites, including www.slimbeautyusa.com, and in some retail stores. 01/21/14 Public Notification
Asset Extreme Plus Product promoted and sold for weight loss on various websites, including www.allnaturalbeelievers.com, and in some retail stores. 12/19/13 Public Notification
Meizitang Citrus Product is promoted and sold for weight loss on various websites and in some retail stores. 12/19/13 Public Notification
Sliming Diet Berry Plus Product is promoted and sold for weight loss on various websites and in some retail stores. 12/19/13 Public Notification
Asset Extreme product promoted and sold for weight loss on various websites, including www.assetcapsules4u.com, and in some retail stores. 12/19/13 Public Notification
SlimEasy Herbs Capsule Product is promoted and sold for weight loss on various websites and in some retail stores. 12/19/13 Public Notification
7 Days Herbal Slim Product promoted and sold for weight loss on various websites, including www.suncoastspaequipment.com, and in some retail stores. 12/19/13 Public Notification
Dr. Ming’s Chinese Capsule Product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com, and in some retail stores. 12/19/13 Public Notification
Zanocap Capsules Stone Independent Reseach Inc. 12/13/13 Recall
Burn 7 Capsules Deseo Rebajar Inc. 12/23/13 Voluntary Recall
Adipotrim XT Deseo Rebajar Inc. 11/19/13 Voluntary Puerto Rico Recall
SlimExtra Herbal Capsules Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Diet Master Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Super Slim Promoted and sold for weight loss on various websites, including www.bonanza.com, and in some retail stores. 11/21/13 Public Notification
“1 Day Diet” Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Body Beauty 5 Days Slimming Coffee Product is promoted and sold for weight loss on various websites and in some retail stores. 11/21/13 Public Notification
Slim Max Product is promoted and sold for weight loss on various websites and in some retail stores. 11/20/13 Public Notification
Jimpness Beauty Fat Loss Capsules Promoted and sold for weight loss on various websites, including www.jimpness.net. 11/07/13 Public Notification
Goodliness Fat-Reducing Product is promoted and sold for weight loss on various websites and in some retail stores. 11/05/13 Public Notification
Perfect Body Solutions and Burn 7 Product is promoted and sold for weight loss on various websites and in some retail stores. 10/10/13 Public Notification
Bella Vi Insane Amp’d and Bella Vi Amp’d Up These products are promoted for weight loss and sold on various websites, including www.pureedgenutrition.com and www.newedgenutrition.com, as well as in retail stores. 10/10/13 Public Notification
Slim Fortune, Lidiy, and Slim Expert B@B Trade Inc. 10/07/13 Voluntary Recall
Dr. Mao Slimming Capsules Product is promoted and sold for weight loss on various websites and in some retail stores. 10/10/13 Public Notification
Be Inspired Product is promoted and sold for weight loss on various websites, including www.beinspirednaturally.com, and in some retail stores. 10/10/13 Public Notification
Oxy Elite Pro and VERSA-1 USP Labs 10/11/13 Warning Letter
“收腹提臀果香型减肥胶囊 ”or “Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang” (translates – Abdomen Hips Fruit Flavored Slimming Capsules) also known as “Сокращать живот и повышать 3ад” (translates – Reducing Belly and Lifting the Buttocks) Product is promoted and sold for weight loss on various websites, including www.instantslim.org, and in some retail stores. 09/17/13 Public Notification
Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 GE Pharma LLC 09/12/13 Recall
Ortiga sold on multiple websites, including www.ebay.com, and in some retail stores 08/22/13 Public Notification
Esbelder Man Capsules, Esbelder Fem Capsules, and Esbelder Siloutte Capsules Herbal Give Care LLC 08/16/13 Voluntary Recall
Best Slim CTV Best Group Inc. 08/03/13 Voliuntary Recall
Quick Thin and Bethel Advance Bethel Nutritional Consulting, Inc. 08/05/13 Expanded Voluntary Recall
Healthy Life Chemistry Purity First B-50 07/26/13 Consumer Warning
Esbelin siloutte te
Esbelin siloutte Herbal Blend with L-Carnitine (30 capsules)
Herbal Give Care LLC 07/19/13 Recall
JaDera
Xiyouji Qingzhi
Dolphin Intertrade Corp. 05/21/13 Recall
Meizi Evolution sold online on various websites including www.ebay.com and in some retail stores 06/27/13 Public Notification
Strawberry Balance sold online on various websites and in some retail stores 06/27/13 Public Notification
Paiyouji Plus sold online on various websites and in some retail stores 06/17/13 Public Notification
Fruit & Plant Slimming sold online on various websites and in some retail stores 06/17/13 Public Notification
Fat Zero sold online on various websites and in some retail stores 06/17/13 Public Notification
Extreme Body Slim sold online on various websites and in some retail stores 06/17/13 Public Notification
Bethel 30 sold online on various websites including www.bethel30.com and in some retail stores 06/10/13 Public Notification
XIYOUJI QUNGZHI CAPSULE sold online on various websites including www.jadera.net. 06/10/13 Public Notification
Zi Xiu Tang Bee Pollen Capsules
Ultimate Formula Bee Pollen Capsules
Zi Xiu Tang Success 05/14/13 Warning Letter
MAXILOSS Weight Advanced Blue Promoted and sold on various websites including www.extremevitaminworld.com and www.dreamlifeweightloss.com 04/04/13 Public Notification
Maxiloss Weight Advanced Softgels Olaax Corp. 02/21/13 Recall
SlimXtreme
SlimXtreme Gold
SlimPlus
SlimLee
GelSlim
SlimDrops
Colonew
Globe All Wellness, LLC 02/14/13 News Release
MAXILOSS Weight Advanced Promoted and sold on various websites including www.dreamlifeweightloss.com and retail stores 01/08/13 Public Notification
SLIMDIA Revolution Promoted and sold on various websites including www.pinkfatty.com and in some retail stores 12/20/2012 Public Notification
Japan Hokkaido Slimming Weight Loss Pills Promoted and sold on various websites including www.ebay.com 11/08/12 Public Notification
Beautiful Slim Body Promoted and sold on various websites including www.houseofmonet.com 11/08/2012 Public Notification
Japan Hokkaido Slimming Weight Loss Pills Promoted and sold on various websites including www.ebay.com 11/08/2012 Public Notification
Brazilian Slimming Coffee Best Share Green Coffee 11/08/2012 Public Notification
Tianji True Slim AmericaQualityHerbs.com 10/4/2012 Public Notification
Classic Zi Xiu Tang Bee Pollen Capsules
Ultimate Formula Capsules
Zi Xui Tang Success, LLC 10/24/2012 Voluntary Recall
ACTRA-Sx 500 Capsules Body Basics 9/18/2012 Recall
Mojo Nights
Mojo Nights for Her
Evol Nutrition Associates Inc. 8/23/2012 Recall
Japan Rapid Weight Loss Diet Pills Green www.amazon.com
distributed by Xiushentang
4/03/2012 News Release
Japan Weight Loss Blue Distributed by: Vitaminbestbuy.com 2/18/2012 News Release
SlimXtreme
ViaXtreme
Global All Wellness, LLC 2/6/2012 Warning Letter

Mince Belle Dietary Supplement
PERFECT Men Dietary Supplement
EVERLAX Dietary Supplement
EVER Slim Dietary Supplement
Herbal Drink Acai-man Mangosteen Dietary Supplement
EVER SLIM Shake Mix Dietary Supplement Strawberry
EVER SLIM Shake Mix Dietary Supplement Chocolate

Healthy People Co. 2/3/2012 Recall
Slimforte Slimming Capsules
Slimforte Slimming Coffee
Botanical Slimming Soft Gel
Intercharm Inc. 07/25/11 Recall
Celerite Slimming Capsules
Celerite Slimming Tea
Shaping Beauty, Inc.
H & S GMP Factory
07/14/11 Warning Letter
Counterfeit Alli
2 Day Diet
Superslim
Meitzitang
Shengyang Zhou 06/03/11 Court Order
Slim Xtreme Herbal Slimming Capsule Globe All Wellness 05/10/11 News Release
Quick Action Slim Tea God’s Garden Pharmacy 05/04/11 Warning Letter
CELERITE Slimming Tea Shaping Beauty, Inc. 03/15/11 Recall
Svelte 30 Svelte 30 Nutritional Consultants 02/09/11 Recall
CELERITE Slimming Capsules Shaping Beauty, Inc. 01/24/11 Recall
Fruta Planta
Reduce Weight Fruta Planta
Reduce Wieght
PRock Marketing, LLC
Godi International, Corp.
12/30/10
01/31/11
Recall
Recall
Leptin Green Coffee 800
Leptin Slimming Coffee
MyLeptin Weight Loss Jelly
Lose Weight Coffee
Bruce Imports 12/09/10 Recall
Weight and Blood Fat Reducing Coffee
Coffee Fast
Tek Shing Trading Pty Limited 11/30/10 Recall
Moti Angel Coffee Moti Group Australia 11/11/10 Recall
Meridia Abbott Laboratories 10/08/10 Recall
AcaiPure Central Coast Nutraceuticals, Inc.
iLife Health and Wellness LLC
Simply Naturals LLC
Health Beauty Solutions LLC
Fit for Life LLC
08/16/10 Court Order
Que She Distributed via:
Online: Bouncing Bear Botanicals
Retail outlets, including: Sacred Journey in Lawrence, Kansas
08/08/10 News Release
Solo Slim® and Solo Slim® Extra Strength EZVille, Ltd. 08/06/10 Recall
Joyful Slim J & H Besta Corp. 07/22/10 Recall
Slim-30 Herb Supplement J & H Besta Corp. 07/16/10 Recall
Accelis
nanoSLIM
Iovate Health Sciences U.S.A. 07/14/10 Court Order
Xenical
Alli
05/26/10 News Release
Lipodissolve (aka mesotherapy, lipozap, lipotherapy, or injection lipolysis)
phosphatidylcholine and deoxycholate
Monarch Medspa, King of Prussia, PA; Spa 35, Boise, ID; Medical Cosmetic Enhancements, Chevy Chase, MD.; Innovative Directions in Health, Edina, MN.; PURE Med Spa, Boca Raton, FLl.; and All About You Med Spa, Madison, IN.
zipmed.net and mesoone.com
04/07/10 New Release
YI SHOU Ultimate Fat Burner 400mg capsules and YI SHOU Ultimate Fat Burner Extra Strength 650mg capsules Healthy Body Forero, Inc. 03/15/10 Warning Letter
Lipoban SlimAmerica, Frank Sarcona et. al.
Lipoban Clinic
03/01/10 Court Order
Chinese Diet Tea
Bio-Slim Patch
Bronson Partners, LLC 01/11/10 Court Order
2 Day Diet
2 Day Diet Slim Advance
2x Powerful Slimming
3 Day Diet
3 Days Fit
3x Slimming Power
5x Imelda Perfect Slimming
7 Day Herbal Slim
7 Days Diet
7 Diet
7 Diet Day/Night Formula
8 Factor Diet
Eight Factor Diet
21 Double Slim
24 Hours Diet
999 Fitness Essence
BioEmagrecim
Body Creator
Body Shaping
Body Slimming
Cosmo Slim
Extrim Plus
Extrim Plus 24 Hour Reburn
Fasting Diet
Fatloss Slimming
GMP
Herbal Xenicol
Imelda Fat Reducer
Imelda Perfect Slim
JM Fat Reducer
Lida DaiDaihua
Meili
Meizitang
Miaozi MeiMiaoQianZiJiaoNang
Miaozi Slim Capsules
Natural Model
Perfect Slim
Perfect Slim 5x
Perfect Slim Up
Phyto Shape
Powerful Slim
ProSlim Plus
Reduce Weihgt
Royal Slimming Formula
Sana Plus
Slim 3 in 1
Slim 3 in 1 Extra Slim Formula
Slim 3 in 1 Extra Slim Waist Formula
Slim 3 in 1 M18 Royal Diet
Slim 3 in 1 Slim Formula
Slim Burn
Slim Express 4 in 1
Slim Express 360
Slim Fast (different from Slim-Fast®)
Slim Tech
Slim Up
Slim Waist Formula
Slim Waistline
Slimbionic
Sliminate
Slimming Formula
Somotrim
Starcaps
Super Fat Burner
Superslim
Super Slimming
Trim 2 Plus
Triple Slim
Venom Hyperdrive 3.0
Waist Strength Formula
Xsvelten
Zhen de Shou
Consumer Info
Counterfeit “Alli” Sold online auction sites Warning
Pai You Guo GMP Herbal Products 11/30/09 Recall
Relacore
Akävar 20/50
Basic Research LLC
Carter-Reed LLC
Dynakor Pharmacal LLC
11/02/09 Court Order
Pineapple Fat Reducing Slimming Capsule
Tomato Slimming (Lose Weight)
Slim Up
Fresh Lemon Slimming (Xian Ning Meng Shou Shen)
Slim Quick Result 3 in 1
Perfect Combination Balishou Capsule
Apple Slim
Shoufsy Activity Girl
Platinum Strategies, Inc. 09/23/09 Warning Letter
Supreme Greens Direct Marketing Concepts, Inc.
ITV Direct, Inc.
King Media, Inc.
Triad ML Marketing, Inc.
08/27/09 Court Order
Slimbionic
One Weight Loss Pill
SlimDemand
Botanical Weight Loss
Young You Corporation 07/15/09 Recall
Counterfeit Hoodia gordonii Nutraceuticals International LLC
Stella Labs LLC
04/27/09 Court Action
ProSlim Plus
3 DAYS fit
EIGHT FACTOR DIET
24hours Diet
Slim 3in1 M-18 ROYAL DIET
3X SLIMMING POWER
Extrim Plus 24 Hours RE-BURN Formula
Slim 3in1 EXTRA SLIM FORMULA
Slim 3in1 EXTRA SLIM WAIST FORMULA
SLIM EXPRESS 360º C
SLIM EXPRESS 4in1
ROYAL SLIMMING FORMULA
BODY CREATOR
Slim Waistline (labeling written in Chinese)
BODY SHAPING
Perfect Slim 100% Natural Herbal Essence
IMELDA Perfect Slim
Slim Waist Formula
Super Slimming
2 DAY DIET
Powerful Slim
BODY SHAPING
SUPER FAT BURNER
SLIMMING FORMULA
SLIM FAST 2
SLIM FAST
Slim up
7 DAYS DIET
Perfect Slim U
JM Fat Reducer
SlimBurn
21 Double SLIM
TRIM PLUS 2
Universal ABC Beauty Supply Iternational, Inc. 04/20/09 Recall
For Women Only weight-loss pills
Lite Bites weight-loss food bars and shakes
Bee-Alive Royal Jelly energy supplements
QVC, Inc. Court Order
Venom HYPERDRIVE 3.0 Applied Lifescience Research Industries Inc. 01/27/09 Warning
ThermaLean
Lipodrene
National Urological Group dbaWarner Laboratories
National Institute for Clinical Weight Loss, Inc.,
Hi-Tech Pharmaceuticals, Inc., dba Planet Pharmacy, Global Pharmacy
01/15/09 Court Order
Ab Force Telebrands Corporation
TV Savings LLC
01/14/09 Court Order
Zhen De Shou Fat Loss Capsules Fashion Sanctuary 11/25/08 Recall
Counterfeit Hoodia gordonii Spear Systems, Inc.
Quebec, Inc., dba Q Web
HBE, Inc.
07/15/08 Court Order

BODYBUILDING

Sten Z and M1 Alpha Andropharm 07/11/17 Voluntary Nationwide Recall
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall – Presence of Anabolic Steroids GEC Laxoplex is marketed as a dietary supplement and sold as a muscle enhancing agent. The product is packaged in a white plastic bottle containing 60 capsules with UPC code 0058049984 and can be identified by GEC Laxoplex. The recall affects all lots of GEC Laxoplex. GEC Laxoplex was distributed Nationwide in the USA through various nutritional supplement retail outlets. 05/08/17 Recall
Tri-Methyl Xtreme Sold and promoted on websites including Ebay 04/13/15 Public Warning
Ortiga Sold and promoted on websites including Ebay 8/22/13 Public Notification
Healthy Life Chemistry B-50 (100 capsules) Healthly Life Chemistry Multi-Meneral (200 capsules) Healthy Life Chemistry Vitamin C (200 capsules) Purity First Health Products Inc. 07/31/13 Recall
Reumofan Plus USA, LLC and Reumofan USA, LLC Reumofan Plus 02/15/13 Recall
Anabolic Xtreme Hyperdrol
Anabolic Xtreme Slim Xtreme
Nutrition Distribution, Inc (previously dba. Anabolic Xtreme) 11/09/11 Plead Guilty
Dienedrone
Liquidrone
Orafinadrol 50
Methyldrostanolone
Advanced Muscle Science (DCD)
R & D Holdings, LLC dba Culver Products
11/10/11 Plead Guilty
Uprizing 2.0 Superior Metabolic Technologies, Inc. 10/05/11 Recall
Novedex XT Gaspari Nutrition Incorproated 10/07/10 Recall
Reversitol Tribravus Enterprises, LLC
iForce Nutrition, LLC
09/16/10 Recall
Arom-X
Arom-X UTT
Arom-XL
4-AD
Decavol
Advanced Muscle Science 09/16/10 Recall
Off Cycle II Hardcore Fizogen Precision Technologies 09/15/10 Recall
Clomed KiloSports Inc. 09/14/10 Recall
ArimaDex Genetic Edge Technologies, Inc 09/13/10 Recall
Smart Powders Piracetam
Primaforce Piracetam
Advanced Muscle Science Arom-X
Advanced Muscle Science 4-AD UTT
G.E.T ArimaDex
iForce Nutrition Reversitol
Fizogen Off Cycle II Hardcore
Unlimited Nutrition 08/30/10 Warning Letter
On Cycle II Hardcore Atlas Operations, Inc. 06/04/10 Warning Letter
MasXtreme Natural Wellness 03/30/10 Recall
Advanced Muscle Science Dienedrone
Advanced Muscle Science Liquidrone
Anabolic Formulation M1, 4AD
Anabolic Formulations 1, 4 AD
Anabolic Xtreme Hyperdrol X2
Anabolic Xtreme 3-AD
BCS Labs Testra-Flex
Competitive Edge Labs M-Drol
Competitive Edge Labs P-Plex
Competitive Edge Labs X-Tren
4Ever Fit D-Drol
Gaspari Novedex XT
Gaspari Halodrol Liquigels
iForce 1,4 AD BOLD 200
iForce MethaDROL
iForce Dymethazine
Monster Caps
MuscleMaster.com, Inc. 01/15/10 Recall
TREN-Xtreme
MASS Xtreme
ESTRO Xtreme
AH-89-Xtreme
HMG Xtreme
MMA-3 Xtreme
VNS-9 Xtreme
TT-40-Xtreme
American Cellular Laboratories, Inc. 07/27/09 Warning Letter
Bromodrol
Dual Action Grow Tabs
Grow Tabs
Ripped Tabs TR
Sold by: IDS Sports 11/12/09 Recall
4Ever Fit D-Drol, Advanced Muscle Science Dienedrone, Advanced Muscle Science Liquidrone UTT, Anabolic Xtreme Hyperdrol X2, APS (aka Advanced Muscle Science) Mastavol, APS (aka Advanced Muscle Science) Revamp, APS (aka Advanced Muscle Science) Ultra Mass Stack, APS (aka Advanced Muscle Science) Ripped Stack, Better Body Sports Finadex, Black China Labs Straight Drol, Black China Labs Straight Phlexed, Body Conditioning Solutions TestraFLEX, Bjorklund Methyldrostanolone, BOSC Enterprises Epi-Tren, BOSC Enterprises Magna Drol, Chaparral Labs Epivol, Chaparral Labs Pheravol-V, Competitive Edge Labs M-Drol, Competitive Edge Labs P-Plex, Competitive Edge Labs X-tren, Diabolic Labs Epio-Plex, Diabolic Labs Finabolic 50, Diabolic Labs Revenge, Ergopharm 6-OXO, Ergopharm 6-OXO Extreme, EST (aka Engineered Sports Technology) MethAnstance , Extreme Labs Susto-Test Depot, Fizogen ON Cycle II Hardcore, G.E.T/ (Genetic Edge Technologies) SUS-500, G.E.T/ (Genetic Edge Technologies) Tren-250, Hardcore Formulations T-Roid, I Force Nutrition 1,4 AD Bold 200, I Force Dymethazine/Reversitol Combo Pack, I Force Reversitol , I Force Nutrition 17a PheraFLEX, I Force Nutrition Dymethazine, I Force Nutrition Methadrol , IDS (aka Innovative Delivery Systems) Bromodrol, IDS (aka Innovative Delivery Systems) Grow Tabs TR, IDS (aka Innovative Delivery Systems) Mass Tabs, IDS (aka Innovative Delivery Systems) Oxodrol Pro, IDS (aka Innovative Delivery Systems) Ripped Tabs TR, IDS (aka Innovative Delivery Systems) Rapid Release, Ripped Tabs, Kilo Sports Massdrol, Kilo Sports Phera-Mass, Kilo Sports Trenadrol, Monster Caps Monster Caps, Myogenix Spawn, Nutra Coastal D-Stianozol, Nutra Coastal H-Drol, Nutra Coastal MDIT, Nutra Coastal S-Drol, Nutra Coastal Trena, Performance Anabolics Methastadrol, Performance Anabolics Tri-Methyl X, Purus Labs E-pol Inslinsified, Purus Labs Nasty Mass, Rage RV2, Rage RV3, Rage RV4, Rage RV5, Redefine Nutrition Finaflex 550-XD, Redefine Nutrition Finaflex Ripped, Transform Supplements Forged Extreme Mass, Transform Supplements Forged Lean Mass Sold by: Bodybuilding.com 11/03/09 Recall
S-DROL (Lot 810481) Nutracoastal Trading LLC 07/28/09 Recall
Methyl 1-D
Methyl 1-D XL
Formadrol Extreme XL
LG Sciences LLC 05/11/09 Forfeiture
Venom HYPERDRIVE 3.0 Applied Lifescience Research Industries Inc. 01/27/09 News Release

 

SEXUAL HEALTH

 

Various unnamed products Just Enhance and R Thomas Marketing LLC 08/31/2018 District Court Enters Permanent Injunction to Stop New Jersey and New York Companies and Executives From Distributing Unapproved and Misbranded Drugs
XXXPlosion Ultra Company unknown-sold on various websites and possibly in some retail stores. 08/13/2018 Public Notification
Panther Power Platinum 11000 Company unknown-sold on various websites and possibly in some retail stores. 08/13/2018 Public Notification
Ding Ji Wei Ge Company unknown-sold on various websites and possibly in some retail stores. 08/10/2018 Public Notification
5K Company unknown-sold on various websites and possibly in some retail stores. 08/10/2018 Public Notification
Platinum Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Krazzy Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Gold Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Boss Rhino 15000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Black Rhino 25000 Company unknown-sold on various websites and possibly in some retail stores. 07/31/2018 Public Notification
Dale Mas Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
C.U. Plus Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
Grakcu Capsule Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
Maximum Powerful Company unknown-sold on various websites and possibly in some retail stores. 07/09/2018 Public Notification
African Viagra, GINSENG, African Superman, Hokkaiodo, MyNicNaxs LLC 07/06/2018 Voluntary Nationwide Recall
Chong Cao Qiang Shen Wang Company unknown-sold on various websites and possibly in some retail stores. 07/03/2018 Public Notification
Maxidus Company unknown-sold on various websites and possibly in some retail stores. 07/03/2018 Public Notification
Black Stallion 35000 Company unknown-sold on various websites and possibly in some retail stores. 07/03/2018 Public Notification
Gold Viagra Company unknown-sold on various websites and possibly in some retail stores. 06/20/2018 Public Notification
XXXPlosion Company unknown-sold on various websites and possibly in some retail stores. 06/20/2018 Public Notification
Euphoric Capsules Epic Products LLC 04/16/2018 Voluntary Nationwide Recall
Best Candy Company unknown-sold on various websites and possibly in some retail stores. 05/14/2018 Public Notification
Rhino 69 Extreme 50000 AMA Wholesale Inc. 04/12/2018 Voluntary Recall
Black Lion Pill Company unknown-sold on various websites, including www.rakuten.com, and possibly in some retail stores. 03/28/2018 Public Notification
Red Zone Xtreme 3000 Company unknown-sold on various websites, including www.ebay.com, and possibly in some retail stores. 03/28/2018 Public Notification
Rhino 69 Extreme 50000 Company unknown-AMA Wholesale Inc. (Distributor/Re-seller) issued recall. Product sold on various websites, including www.bonanza.com, and possibly in some retail stores. 03/28/2018 Public Notification
All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg Marmex Corp 12/13/17 Voluntary National Recall
Chao Jimengnan Company unknown-sold on various websites, including www.spanishfly.com, and possibly in some retail stores. 11/30/17 Public Notification
Bull and Chao Jimengnan Tablets Nutra Labs Inc. 11/30/17 Voluntary National Recall
Tyrannosaurus Company unknown 11/20/17 Public Notification
V9 Male Sexual Stimulant Company unknown 11/20/17 Public Notification
S.W.A.G. II Platinum 33K Company unknown. 11/20/17 Public Notification
Rhino 69 Premium 8000 Company unknown 11/20/17 Public Notification
Rhino 25K 15000 Company unknown 11/20/17 Public Notification
Rhino 12 Titanium 6000 Company unknown 11/20/17 Public Notification
Rhino 11 Platinum 11000 Company unknown 11/20/17 Public Notification
Qibianli Company unknown 11/20/17 Public Notification
Pro Solution Company unknown 11/20/17 Public Notification
New Stiff Nights Platinum 10K Company unknown 11/20/17 Public Notification
MenXtrong Company unknown 11/20/17 Public Notification
Blue Diamond Pill Company unknown 11/20/17 Public Notification
Control Capsules Company unknown 11/20/17 Public Notificaion
Blue Pearl All Natural Male Enhancement Company unknown-product promoted and sold on various websites, including www.bluepearlformen.com (redirects to www.bluefusions.com), and possibly in some retail stores. 11/20/17 Public Notification
Hard Times for Men Company unknown-product promoted and sold on various websites, including www.blankterrmall.com, and possibly in some retail stores. 11/20/17 Public Notification
Tiger 5000 Company unknown-product promoted and sold on websites and possibly retail stores. 09/20/17 Public Notification
Vegetable Vigra Nature Supplement Inc. 09/20/17 Voluntary Florida Recall
Man of Steel 1 and Man of Steel 2 Man of Steel 08/04/17 Voluntary National Recall
Super Panther 7K Ultra Shop Supplement 07/21/17 Voluntary National Recall
RHINO 7 Platinum 5000 Company unknown 07/17/17 Public Notification
Royal Honey VIP Company unknown 07/17/17 Public Notification
Kingdom Honey for Him Company unknown 07/17/17 Public Notification
Kingdom Honey for Her Company unknown 07/17/17 Public Notification
Kopi Jantan Tradisional Natural Herbs Coffee Bestherbs Coffee LLC 07/17/17 Voluntary National Recall
Triple X 2000 SHH Trading 06/23/17 Public Notification
Triple Premium Zen Gold 1300mg SHH Trading 06/23/17 Public Notification
XXX Zone Platinum SHH Trading 06/23/17 Public Notificaion
Triple Miracle Zen Plus 1200mg SHH Trading 06/22/17 Public Notification
Macho Man 3000 SHH Trading 06/22/17 Public Notification
Monster X 1350 SHH Trading 06/22/17 Public Notification
Own the Knight 1750 SHH Trading 06/22/17 Public Notification
Royal Master 1500 SHH Trading 06/22/17 Public Notification
Xzone Gold SHH Trading 06/22/17 Public Notification
Love Zen 3000 SHH Trading 06/22/17 Public Notification
Super Panther 7K Company unknown-product promoted and sold on various Web sites, including www.ultraxshop.comdisclaimer icon, and possibly in some retail stores. 06/22/17 Public Notification
Man of Steel 2 Company unknown-product promoted and sold on various Web sites, including www.manofsteelpills.comdisclaimer icon, and possibly in some retail stores. 06/22/17 Public Notification
Man of Steel Company unknown-product promoted and sold on various Web sites, including www.manofsteelpills.comdisclaimer icon, and possibly in some retail stores. 06/22/17 Public Notification
Caverflo Natural Herbal Coffee Caverflo.com 05/25/17 Voluntary National Recall
Megajex MS Bionic 05/03/17 Warning Letter
Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. Organic Herbal Supply is also recalling Zrect for Women and LabidaMAX capsules Organic Herbal Supply Products 04/18/17 Voluntary National Recall
Black Ant (4600 mg), Indian God Lotion, Evil Root (1200 mg), Germany Black Gold (2800 mg), Germany Niubian (3000 mg), Hard Ten Days (4500 mg), Lang Yi Hao (Chaonogsuopian) (500 mg), Gold Vigra, Clalis, Ye Lang Shen (5000 mg), Zhansheng Weige Chaoyue Xilishi (2000 mg), Zhonghua Niubian (2000 mg), Stree Overlord (3800 mg), Max Man (3000 mg), Hu Hu Sheng Wei, Tiger King, Viagra 100 (2000 mg), Power V8 Viagra (200 mg), Dadiyongshi Xiangganglongshengwu, Lien Chan for Seven Days, Maca Gold (6800 mg) A&H Focal Inc. 03/07/17 National Recall
Arouse-Plus Company unknown 03/03/17 Public Notification
Bazook Bullet Company unknown 03/03/17 Public Notification
XtraHRD Natural Male Enhancement Capsules Organic Herbal Supply 02/22/17 Recall
Goldreallas Original Company unknown 02/03/17 Public Notification
Ginseng for Reinforcing Kidney Company unknown 02/03/17 Public Notification
Old Chinese Company unknown 02/02/17 Public Notification
Shenjingpian Company unknown 02/02/17 Public Notification
Goldreallas XXX Company unknown 02/02/17 Public Notification
XtraHRD Company unknown 01/26/17 Public Notification
Duramaxx Company unknown 12/22/16 Public Notification
African Viagra Company unknown 12/22/16 Public Notification
Triple Green Capsules Company unknown 12/22/16 Public Notification
Power Male Sexual Stimulant Company unknown 12/22/16 Public Notification
Rhino 8 Platinum 8000 Company unknown 12/22/16 Public Notification
Black 3K Plus Male Sexual Enhancement Capsules Company unknown 12/22/16 Public Notification
Rhino 5 1500 Capsules Company unknown 12/22/16 Public Notification
Black Mamba 2 Premium Company unknown 12/22/16 Public Notification
Bl4ck 4K Capsules Company unknown 12/22/16 Public Notification
Rhino 7K 9000 Male Performance Booster Company unknown 12/22/16 Public Notification
Lang Yi Hao Company unknown 12/22/16 Public Notification
Rhino 9 Premium 3500 Company unknown 12/22/16 Public Notification
90° Jiushidu Capsules Company unknown 12/22/16 Public Notification
Big Penis Male Sexual Stimulant Company unknown 12/22/16 Public Notification
Megajex Natural Male Sex Enhancer MS Bionic, Inc. 11/29/16 Voluntary Nationwide Recall
Ready Man! Company unknown 11/09/16 Public Notification
Stiff Bull Herbal Coffee Company unknown 09/16/16 Public Notification
Kopi Jantan Tradisional Natural Herbs Coffee Company unknown 08/30/16 Public Notification
One More Night Company unknown 08/16/16 Public Notification
Love4Long Company unknown 08/16/16 Public Notification
Master Zone 1500 Company unknown 08/16/16 Public Notification
Boss-Rhino Gold X-tra Strength Company unknown 08/09/16 Public Notification
Anaconda Strong Formula Company unknown 08/09/16 Public Notification
De Guo Hei Bei Company unknown 08/09/16 Public Notification
Ziyinzhuangyang Company unknown 07/29/16 Public Notification
Weili (Yi Pao Dao Tian Liang) Company unknown 07/28/16 Public Notification
Super Shangai Company unknown 07/27/16 Public Notification
The Golden Root Company unknown 07/27/16 Public Notification
Shangai Ultra X Company unknown 07/27/16 Public Notification
Super Bull 6000 Company unknown 07/27/16 Public Notification
Power Spring (XXX) Oral Liquid Company unknown 07/27/16 Public Notification
Libigirl Company unknown 07/27/16 Public Notification
My Steel Woody Company unknown 06/30/16 Public Notification
DR’s Secret Bio Herbs Coffee Company unknown 06/01/16 Public Notification
Black Label X Company unknown 04/26/16 Public Notification
Salute Capsules Company unknown 03/17/16 Public Notification
ZlimXter Capsules Company unknown 03/17/16 Public Notification
Sextra Company unknown-Product promoted and sold on various websites, including www.iShopLSTV.com. 03/03/16 Public Notification
Bull’s Genital Company unknown-Product promoted and sold on various websites, including www.bullsgenital.com. 02/11/16 Public Notification
Zhong Hua Niu Bian Company unknown-Promoted and sold on various websites, including www.zhonghuaniubian.com. 02/11/16 Public Notification
Weekend Prince Company unknown 02/11/16 Public Notificaton
Bull Company unknown-Promoted and sold on various websites, including www.bullsexpills.com. 02/11/16 Public Notification
Mamba is Hero Company unknown 02/05/16 Public Notification
Ninja-X Company unknown 02/05/16 Public Notification
Ginseng Power-X Company unknown 02/05/16 Public Notificaton
Boss Number #6 Company unknown 02/05/16 Public Notification
Golden Night Company unknown 02/05/16 Public Notification
Wonder-Erect Male Pills Company unknown 01/21/16 Public Notification
Wonder-Erect Male Gum Company unknown 01/21/16 Public Notification
Black Ant, Herb Viagra, Real Skill, Weekend Prince, African Black Ant And Stree Overlord Along With Multiple Other Products R Thomas Marketing LLC 01/09/16 Nationwide Recall
Xtra Zone 2400 Company unknown 12/28/15 Public Notification
OrgaZen 3000 Company unknown 12/28/15 Public Notification
Rhino 7 Blue 9000 Company unknown 12/28/15 Public Notification
Rhino Big Horn 3000 Company unknown 12/28/15 Public Notification
Diamond 3500 Company unknown 12/28/15 Public Notification
Triple MiracleZen Extreme 1750 mg Company unknown 12/28/15 Public Notification
Eros Power Zone 1900 Company unknown 12/28/15 Public Notification
OrgaZen 3500 Company unknown 12/28/15 Public Notification
Xtra Zone 2200 Company unknown 12/28/15 Public Notification
Xtra Zone 2600 Company unknown 12/28/15 Public Notification
Triple Power Zen Gold 2000 Company unknown 12/28/15 Public Notification
Triple Power Zen Plus 2000 Company unknown 12/28/15 Public Notification
Triple MiracleZen Gold 1750mg Company unknown 12/28/15 Public Notification
APEXXX Nuway Distributors 12/23/15 Nationwide Recall
Power Tiger-X Company unknown-Promoted and sold on various websites, including www.everestwholesales.com, and in some retail stores. 12/17/15 Public Notification
Fuel Up Plus Reesna Inc. 12/11/15 Nationwide Recall
Fuel Up High Octane Reesna Inc. 12/11/15 Nationwide Recall
Australia Kangaroo Essence Company unknown 11/19/15 Public Notification
Effective Viagra Tablets Company unknown 11/19/15 Public Notification
Sex Drive Capsules Company unknown 11/19/15 Public Notification
XForMan Plus Company unknown 11/19/15 Public Notification
Rhino X Company unknown 11/19/15 Public Notification
Power Khan Company unknown 11/05/15 Public Notification
Wild Sexx Capsules Company unknown 10/23/15 Public Notification
Ultra SX Capsules Company unknown 10/23/15 Public Notification
Super Dragon 6000 Capsules Company unknown 10/23/15 Public Notification
Sex-Love Secret Code Capsules Company unknown 10/23/15 Public Notification
Paradise Suplemento Natural Ultra Plus Capsules Company unknown 10/23/15 Public Notification
Fuel Up Plus Company unknown 10/23/15 Public Notification
Fuel Up High Octane Company unknown 10/23/15 Public Notification
APEXXX Nuway Distributors 10/23/15 Public Notification
S.W.A.G.G.E.R Extreme Capsules Company unknown 10/23/15 Public Notification
Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules TF Supplements 10/09/15 Voluntary Nationwide Recall
Kaboom Action Strips Company unknown 09/21/15 Public Notification
Extreme Diamond 3000 Company unknown 04/30/15 Public Notification
King of Romance Company unknown 04/30/15 Public Notification
Viagra 700 Company unknown 04/30/15 Public Notification
Black Panther Company unknown 04/30/15 Public Notification
Herb Viagra Male Sexual Stimulant Company unknown 03/11/15 Public Notification
Bigger Longer More Time More Sperms (sic) Company unknown 03/05/15 Public Notification
Black Ant King Company unknown 03/05/15 Public Notification
Black Mamba Premium Company unknown 03/05/15 Public Notification
African Superman Company unknown 03/05/15 Public Notification
La Pepa Negra Company unknown 03/03/15 Public Notification
Stiff Nights Company unknown 03/03/15 Public Notification
Stiff Nights Company unknown 03/03/15 Public Notification
Herb Viagra Company unknown 03/03/15 Public Notification
Rhino Blitz Gold 3000 Company unknown 03/03/15 Public Notification
Vim-25 Company unknown 03/03/15 Public Notification
Baolong Company unknown 03/03/15 Public Notification
Male Silkworm Moth Nourishing Oral Liquid Company unknown 03/03/15 Public Notification
Sex Men Company unknown 03/02/15 Public Notification
Santi Scalper Company unknown 03/02/15 Public Notification
Vigra Company unknown 03/02/15 Public Notification
Plant Vigra Company unknown 03/02/15 Public Notification
Super Hard Company unknown 03/02/15 Public Notification
Vigour 300 Company unknown 03/02/15 Public Notification
MME MAXMAN Company unknown 03/02/15 Public Notification
Hard Wang Company unknown 03/02/15 Public Notification
FX3000 Company unknown 03/02/15 Public Notification
Libigrow XXX Treme Company unknown 02/28/15 Public Notification
Night Man Company unknown 02/28/15 Public Notification
Black King Kong Company unknown 02/28/15 Public Notification
72HP Company unknown 02/27/15 Public Notification
Tibet Babao Company unknown 02/27/15 Public Notification
Germany Niubian Company unknown 02/27/15 Public Notification
Happy Passengers Company unknown 01/21/15 Public Notification
Samurai-X Company unknown 12/23/14 Public Notification
Zhansheng Weige Chaoyue Xilishi Company unknown 12/23/14 Public Notification
Triple PowerZEN Gold Company unknown 12/23/14 Public Notification
Black Storm Company unknown 11/24/14 Public Notification
Mayhem Company unknown 11/13/14 Public Notification
Herbal Vigor Quick Fix Company unknown-Promoted and sold for sexual enhancement on various websites, including www.calcompnutrition.com, and in some retail stores. 08/11/14 Public Notification
Arize Company unknown-Promoted and soldon various websites, including www.calcompnutrition.com, and in some retail stores. 08/11/14 Public Notification
O.M.G. Company unknown 07/22/14 Public Notification
Gold Vigra Company unknown 06/17/14 Public Notification
Miraculous Evil Root Company unknown 06/17/14 Public Notification
Zhen Gong Fu Company unknown 06/05/14 Public Notification
Liu Bian Li Company unknown 06/02/14 Public Notification
Dick’s Hard Up Company unknown 06/02/14 Public Notification
Eyeful Company unknown 06/02/14 Public Notification
3 Hard Knights Company unknown 06/02/14 Public Notification
Full Throttle on Demand Company unknown 06/02/14 Public Notification
GoldReallas Company unknown 06/02/14 Public Notification
African Black Ant, Black Ant, Mojo Risen Eugene Oregon 05/28/14 Voluntary Recall
MV5 Days Company unknown 05/16/14 Public Notification
S.W.A.G. Company unknown-Promoted and sold on various websites, including www.SexWithAGrudge.com, and in some retail stores. 04/16/14 Public Notification
African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), XZone 1200 (Lot# 13071012) and Mojo Risen (Lot# 10081359) Nova Products Inc. 04/01/14 Voluntary Nationwide Recall
Weekend Warrior Company unknown-Product promoted and sold on various websites, including www.onlinecoralcalcium.com, and in some retail stores. 03/07/14 Public Notification
Bali Mojo Company unknown 01/28/14 Public Notification
Tiger King Company unknown 01/28/14 Public Notification
Vimax Company unknown 01/28/14 Public Notification
JINQIANGBUDOR Red Dragon Company unknown 01/28/14 Public Notification
SexRx Company unknown-Product promoted and sold on various websites, including www.alternative-health-supplements.com, and in some retail stores. 01/28/14 Public Notification
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men, “New” Extenze, and New XZen Platinum Midwest Wholesale 01/09/14 Voluntary Recall
CONTROL All Natural Sexual Enhancement Company unknown 12/19/13 Public Notification
Best Whips Company unknown 12/19/13 Public Notification
P-Boost AKA NatuRECT Tendex 11/19/13 Voluntary Recall
RezzRX Fossil Fuel Products LLC 11/18/13 Voluntary Recall
Rhino 5 Plus, Maxtremezen and Extenzone Jobbers Wholesale 11/16/13 Voluntary Recall
Alpha Male Company unknown 11/21/13 Public Notification
ExtenZe Maximum Strength lot number 0512058 Company unknown 11/12/13 Consumer Warning
Vitalikor Fast Acting Company unknown-Promoted and soldon various websites and in retail stores, such as www.vitalityresearchlabs.com, www.vitalikor.com, and in GNC stores (including on www.gnc.com). 11/08/13 Public Notification
Wood-E Company unknown 09/24/13 Public Notification
XZone Premium Company unknown 09/24/13 Public Notification
Xzen 1200, Xzen Gold or Xzen XPress Company unknown 09/24/13 Public Notification
Virilis Pro, PHUK and Prolifta Haute Health LCC 09/24/13 Voluntary Recall
72HP, Evil Root and Pro Power Max Hardmenstore.com 08/27/13 Voluntary Recall
Jack Rabbit Jack Rabbit Inc. 08/12/13 Voluntary Recall
Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules Volcano Company 07/18/13 Voluntary Worldwide Recall
Silver Sword and Clalis Hardmenstore.com 07/05/13 Voluntary Recall
Silver sword Company unknown-promoted and sold on various websites including www.hardmenstore.com and in some retail stores 06/28/13 Public Notification
Exten 1300 Company unknown 06/28/13 Public Notification
MVP Mega Company unknown 06/28/13 Public Notification
MaxTreme Zen Company unknown 06/28/13 Public Notification
Clalis Company unknown 06/28/13 Public Notification
Royal Dragon Herbal Tonic Balls Company unknown 06/17/13 Public Notification
Mojo Risen Company unknown 6/10/13 Public Notification
Reload Company unknown-sold on various websites including www.reloadpill.com and in some retail stores 6/10/13 Public Notification
Cave Diver Company unknown-sold on various websites including www.bonanza.com and in some retail stores 6/10/13 Public Notification
X Zen Platinum Company unknown 6/10/13 Public Notification
Super Cheetah Company unknown-sold online on various websites including www.bonanza.com and in some retail stores 06/10/13 Public Notification
Nights to Remember Company unknown 06/10/13 Public Notification
Get It Up Company unknown 06/10/13 Public Notification
SexVoltz
Velextra
Amerect
Beamonstar Products 05/07/13 Recall
Bullet Proof Company unknown 05/07/13 Public Notification
Lightning Rod Capsules Chang Kwung 05/07/13 Recall
Vicerex Capsules
Black Ant Capsules
American Lifesyle 05/01/13 Recall
Sex Plus sold online and some retail stores 04/25/13 Public Notification
Zoom-Zooma-Zoom Company unknown 04/25/13 Public Notification
Affirm XL Affirm XL, Inc. 04/10/13 Recall
Love Rider Company unknown 04/03/13 Public Notification
AFFIRM XL Company unknown 04/03/13 Public Notification
Nina Mojo Company unknown 04/03/13 Public Notification
ROCK-IT MAN Consumer Concepts, Inc. 04/01/13 Recall
Rock-It Man sold online 03/21/2013 Public Notification
Libido Sexual Enhancer sold online 03/21/13 Public Notification
Stiff Days Company unknown 03/21/13 Public Notification
X-ROCK All Natural for Men
Z-ROCK All Natural
X-ROCK All Natural 3 Day Pill For Men
X-ROCK for ERECTILE REFUNCTION, The 3 Day Pill
Coral Rock Man Inc. dba CRM Laboratories 03/13/2013 Warning Letter
Night Bullet Green Planet, Inc. 03/12/13 Recall
Super Power D&S Herbals, LLC 01/24/13 Recall
Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® Performance Plus Marketing Inc. 12/17/12 Recall
Evol Nutrition Associates, Inc./ Red Dawn Issues Voluntary Nationwide Recall of Dietary
Supplements
Mojo Nights and Mojo Nights for Her 9/21/12 Recall
ACTRA-Sx 500 Capsules Body Basics, Inc. 9/18/12 Recall
X-ROCK 3 Day Pill for Men & Z ROCK sold online 07/24/2012 Public Notification
IBU-RELIEF 12
Idebenone
Sexual Virility Max
ABCO Laboratories, Inc. 06/19/2012 Warning Letter
Kaboom Action Strips www.kaboomformen.com and in some retail stores 05/25/2012 Public Notification
Mojo Nights Sold online, and various retail stores 05/25/2012 Warning
V Maxx Rx www.themensclub.net www.vmaxxrx.com 05/25/2012 Recall-Firm Press Release
EreXite Sold online, including www.amazon.com 05/22/2012 Public Notification
Firminite
Extra Strength Instant Hot Rod
Libidron
West Coast Nutritionals, Ltd. 05/18/2012 Recall-Firm Press Release
Firminite Sold online, www.firminit.com 05/16/2012 Public Notification
Boost-Ultra Sexial Enhancement Formula Sold online, www.bosstultra.biz 05/16/2012 Public Notification
VMaxx Rx Sold online, www.vmaxxrx.com 05/16/2012 Public Notification
X-Rock CRM Laboratories, sold online 4/18/2012 Recall

Public Notification

Stree Overlord Sold online 4/05/2012 Public Notification
African Black Ant Sold online, ebay.com 4/05/2012 Public Notification
France T253 Sold online, ebay.com 4/03/2012 Public Notification
Man King Sold online 2/18/2012 Public Notification
Hard Ten Days Sold online 2/18/2012 Public Notification
RegenErect Regeneca, Inc. 2/27/2012

Recall

Press Release

RegenArouse Regeneca, Inc. 2/10/2012 Recall
Virility Max Keime Inc dba Barry’s Vitamins 11/10/11 Recall
ViaXtreme Global Wellness, LLC 06/06/11 Recall
Regenerect Ethos Environmental, Inc.
d.b.a. Regeneca International, Inc.
05/25/11 Warning Letter
Regenerect Ethos Environmental, Inc.
d.b.a. Regeneca International, Inc.
04/28/11 Recall
Duro Extend Intelli Health Products, LLC 04/27/11 Warning Letter
X-Hero
Male Enhancer
USA Far Ocean Group, Inc. 03/29/11 Recall
THE BEST Enhancer AVNS, Inc. 03/28/11 Recall
Black Ant Sold online 03/16/11 News Release
EXTENZE Biotab Nutraceuticals, Inc. 02/22/11 Recall
Nite Rider Maximum Sexual Enhancer For Men
STUD Capsule for Men
Kanec USA, Inc. 01/18/11 Recall
Rock Hard Extreme
Passion Coffee
Drive Total Energy 12/30/10 Recall
RockHard Weekend
Pandora
RockHard Laboratories 12/22/10 Recall
Man Up Now Synergy Distribution LLC 12/15/10 News Release
Duro Extend Capsules For Men Intelli Health Products 12/2/10 Recall
Vigor-25 Piston Corp. 11/19/10 News Release
MasXtreme
Passion Power for Men
Passion Power for Women
Natural Wellness, LLC 10/05/10 Warning Letter
Magic Power Coffee INZ Distributors, Inc. 08/23/10 Warning Letter
TimeOut Capsules Sold online 08/25/10 News Release
Mr. Magic Male Enhancer Glow Industries, Inc. 08/18/10 Recall
Stiff Nights
Aziffa
Size Matters
Erex
Mojo
Hard Drive
Eyeful
Red Magic
Straight Up
Zotrex
Monster Excyte
WOW
Xaitrex
Verec
Prolatis
Xytamax
Maxyte
Libidinal
OMG
OMG45
Zilex (with Golden Spear)
Novacare LLC 08/10/10 Recall
Prolatis’ Prolatis’ 08/09/10 Recall
Revivexxx Extra Strength EZVille, Ltd. 08/06/10 Recall
Ejaculoid XXTREME
Stimuloid II
Nutraloid Labs, Inc. 07/28/10 Recall
Vialipro Good Health, Inc. 07/16/10 Recall
Natural Progesterone Cream USP with Adrenal Support
Testosterone Cream Formula FOR WOMEN
Testosterone Cream Formula FOR MEN
Total HGH Cream
LibidoEdge Capsules NATURAL SEXUAL ENHANCEMENT
Libido Edge Labs, LLC 06/10/10 Warning Letter
Rock Hard Weekend
72 Hours
Stamin I
Finally On Demand
Stamini
Vierect
Atlas Operations, Inc. 06/04/10 Warning Letter
Vitalex Vitapro 04/20/10 Prison Sentence
Super Shangai
Strong Testis
Shangai Ultra
Shangai Ultra X
Lady Shangai
Shangai Regular
Shangai Chaojimengnan
Naturalë Super Plus
Shangai Distributors Inc. 04/08/10 News Release
Stud Capsule For Men Kanec USA, Inc. 04/02/10 Recall
Stiff Nights Impulsaria LLC 11/05/09 News Release
Enzyte Berkeley Premium Nutraceuticals, Inc. 07/22/09 Court Order
LibieXtreme
Y-4ever
Libimax X Liquid
Powermania Liquid
Capsule
Herbal Disiac
Opteron 1 Inc. dba Nature & Health Co. 07/15/09 Recall
Stamina-Rx Hi-Tech Pharmaceuticals, Inc. 07/15/09 Recall
Libipower Plus Haloteco 07/13/09 Recall
Actra-Rx
Actra-Sx
Libidus
Nasutra
Neophase
Vigor-25
Yilishen
Zimaxx
4EVERON
Liviro3
Lycium Barbarum L.
Adam Free
Rhino V Max
V.Max
True Man
Energy Max
HS Joy of Love
NaturalUp
Blue Steel
Erextra
Hero
Xiadafil VIP tablets (Lots 6K029 and 6K209-SEI only)
Sold online Consumer Update
Zencore Plus Bodee LLC 03/11/09 Recall
Spontane-ES National Urological Group dbaWarner Laboratories
National Institute for Clinical Weight Loss, Inc.,
Hi-Tech Pharmaceuticals, Inc., dba Planet Pharmacy, Global Pharmacy
01/15/09 Court Order
Rize 2 The Occasion
Rose 4 Her
Jack Distribution, LLC
G & N works, Inc.
Devine Distribution, Inc.
07/28/08 Recall
Xiadafil VIP SEI Pharmaceuticals, Inc. 07/28/08 Seizing
Xiadafil VIP SEI Pharmaceuticals, Inc. 05/27/08 Recall
Viapro (in 375mg capsules) EG Labs, LLC 07/23/08 Recall
Viril-Ity-Power (VIP) Tabs International Pharmaceuticals, Ltd. 05/29/08 Recall
Blue Steel
Hero
Active Nutraceuticals
Marion Group
05/25/08 News Release
BOOM! Yoi Jin Sei LLC 04/23/08 Court Order
Shangai Regular
Shangai Ultra
Super Shangai
Naturalë Super Plus
Lady Shangai
Shangai Distributors Inc. 04/9/08 Seizing
Maxidus pills KG Enterprises LLC 03/31/08 Recall
Aspire36
Aspire Lite
Palo Alto Labs 02/28/08 Recall
Encore Tabs Bodee LLC 11/21/07 Recall
True Man’s Sexual Energy Nutriment Men’s Formula
Energy Max
Energy Supplement Men’s Formula
America True Man Health Incorporated 11/16/07 Recall
Nasutra Nasutra, LLC 09/20/06 Recall
SIGRA
STAMINA Rx
STAMINA Rx for Women
Y-Y
Spontane ES
Uroprine
NVE Inc., distributed by Hi-Tech 06/20/03 News Release

AUSTRALIA

09/23/18:NET Remedies homeopathic products
08/22/18:Liangzern Dietary Supplements
08/22/18:Germany Niubian tablets
08/22/18:Rhino 8 Platinum 8000 capsules
08/15/18:G Female Oral Tablets
08/02/18:Fairy capsules
06/28/18:Need for Seal tablets
06/28/18:Gold Maka tablets
06/28/18:One Night Lover tablets
06/19/18:Platinum-Male Enhancer tablets
06/19/18:Bulbao Male Enhancer tablets
06/19/18:Meltz-Instant Energy for Male tablets
06/05/18:Camellia sinensis (green tea) extract
06/02/18:Solve Botanical Slimming capsules
05/23/18:Hypnotic poisom capsules
05/17/18: Jaguar 30000 capsules
05/14/18:Lishou Strong Slimming capsule
03/07/18:Ja Dera Max+ capsules
02/28/18:Help 100% & Pure Natural & Body Slim capsules
02/06/18:Perfect slim capsules by Peenuch
01/16/18:Yunnan Feng Shi Ling capsules – counterfeit
12/19/17:Counterfeit: SLAM Natural Formula 29000 mg capsules
12/11/17:Semenax capsules (counterfeit version)
11/13/17:Super Soniic Capsules
11/13/17:Hard Rod Plus Capsules
11/09/17:LISHOU Fuling Jiaonang Capsules
11/07/17:Red Ant Tablets
11/07/17:Maximum Powerful (Baiwei USA) tablets
11/02/17:Lose Weight 30 Capsules
11/02/17:Beautiful Lose Weight Gold 30 Capsules
10/18/17:Jimpness Beauty Fat Loss capsules
09/18/17:Body Con Plus Capsules
09/18/17:7 Day Slim Extreme capsules
08/28/17:Rhino 9 Capsules
08/25/17:Recall – Oh Baby!, JO LMax Extra and RUFF Natural Formula
08/04/17:Maxidus capsules
08/04/17:Majestic African Mango capsules
08/04/17:Herbal Max Real Slim Capsules
08/02/17:Germany Black Gorilla tablets
07/27/17:Bittermelon Slimming Capsules
07/25/17:RUFF Natural Formula capsules
07/24/17:V8 Tablets
07/24/17:Jing Pin Heijin Gang Tablets
06/13/17: Slimming Capsule-Reduce Fat
05/30/17: Jinqiangbudor Red Dragon Tablets
05/30/17: Dragon Power (Yong Gang Tablets)
05/12/17: Man XXX Herbal capsules
05/04/17: Black Gorilla tablets
05/04/17: France T253 capsules
05/04/17: Gold Reallas XXX capsules
05/04/17: Dragon Power Capsules
05/04/17: Real Skill Male Sexual Stimulant capsules
05/04/17: V9 Male Sexual Stimulant tablets
05/04/17: Rize N Shine tablets
05/04/17: XXXL Penis Enlarging Ointment
05/04/17: MME Maxman IX capsules
05/04/17: 100% Healthy Food For Men tablets
05/02/17: Maxman IV capsules
05/02/17: Dragon Max capsules
05/02/17: Maxman Premium capsules
05/02/17: Maxman V capsules
05/02/17: MMC Maxman XI tablets
05/02/17: New Advanced Technological tablets
04/20/17: Slim-Vie Slimming Capsules
04/11/17: Lose Weight Capsules
04/08/17: Nangen Zengzhangsu capsules
03/15/17: Change Me Herbal Slimming capsules
03/09/17: Africa Black Ant capsules

New FDA Requirements for Imported Ingredients

by NaturPro in Quality Comments: 0

Importing any food or supplement products? Do you have training, procedures and records according to FDA’s FSVP guidance? 

Many firms in the food and dietary supplement industry are quietly putting significant investment into meeting the Food Safety Modernization Act (FSMA). FSMA was signed by President Obama in 2011 as the first major legislation to update food safety regulations in more than 50 years. FSMA and FSVP represent the best approach to ensuring a safe global food chain.

supplement food verification

For supplements and health foods, its more reliable to verify than it is to trust.

FDA Requires You To Do these Things:

  1. Your FSVP includes all written procedures and records that demonstrate compliance with FSMA, especially the requirements for Supply Chain Preventive Controls (PC). If you purchase any ingredients directly from foreign sources outside the U.S., then you must have a written FSVP. And if your U.S. based supplier imports ingredients, you are responsible for verifying their FSVP is effective.
  2. Warehouses, marketers and distributors, and supplement manufacturers are subject to “modified” FSVP requirements. Even if you don’t receive product, or open any containers, you must still verify those you designate to handle, order, process or store your product.  If your name is on the  label of any product or package, then you must be able to show (with written documentation) that your supplier, warehouse, processor, and customer ensures the safety of the product within 24 hours of the FDA visiting you or requesting this information by phone.
  3. If you import, own and/or have a financial stake in the imported goods, then you are probably responsible for the goods as the designated “FSVP Importer”. For imports involving multiple U.S. parties, there must be a written agreement specifying who is responsible for what. Foreign firms who send goods to the U.S. without a designated buyer must have a U.S.-based agent to act as importer, and take responsibility for the shipment once it arrives to the U.S.
  4. You need to have a Qualified Individual or QI to write your FSVP. No standard training is required to be a QI, but it will greatly help your QI to be trained on PCQI and/or FSVP. Because the final FSVP rule includes more than 300 mentions of the word ‘flexibility’, you still gotta know what you’re doing.
  5. With few exceptions, importers must perform a hazard analysis on all imported products. This requires you to know how your ingredients are grown and made, where they came from, and what biological, chemical or physical hazards may be present that could make them unsafe. A hazard requiring a preventive control is defined as one that is “known or reasonably foreseeable to cause significant injury or illness”. It’s up to your QI to determine these hazards.  You can agree in writing with your supplier or customer to ensure that they are responsible for a preventive control – otherwise, the responsibility probably falls on you.
  6. The most common hazards are:
    1. Undeclared allergens
    2. Salmonella
    3. Listeria
    4. These three are the source of 88% of all product recalls! 
  7. Economically Motivated Adulteration (EMA) and radiological contamination are often overlooked as hazards, and often require PC in the FSVP guidance.
  8. Much of the available information on hazards is provided by FDA for free. Some examples:
    1. FDA Import Alerts
    2. FDA Warning Letters
    3. FDA Product Recalls
    4. FDA Guidance on Potential Hazards for Foods and Processes
    5. FDA Bad Bug Book
    6. FDA Guidance on Chemical Hazards
    7. FDA Reportable Food Registry
    8. Product specifications that control for hazards like salmonella and allergens. These are often not publicly available, but many are found on industry databases like UL Prospector.
  9. The easiest and most impactful thing you can do to start evaluating your foreign supplier is to request their hazard analysis!
  10. Third party experts are the most popular way to develop FSVP programs. A couple days of staff training is not the same as experience and expertise, especially with today’s global supply. Remember that suppliers are not allowed to verify themselves – this duty is left to customers, third party auditors, or other qualified individuals sent on behalf of the customer.

If you don’t have the time or expertise on staff to handle your supplier verification according to FSMA, make sure you talk to someone trained in FSVP with experience in qualifying your type of products and suppliers.

For more information on FSVP, visit the FDA page “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

NaturPro Scientific LLC is a leading natural products consultancy specializing in evaluating and maximizing the value of foods and dietary supplements. Contact us for more information at http://naturproscientific.com/contact-us

 

Workshop on Product Testing at Supplyside

by NaturPro in Quality Comments: 0

2018 SUPPLYSIDE WORKSHOP — Effectively Partnering with a Contract Laboratory

Location: Lower Level, North Convention Center

Wednesday, November 7 | 1:30-4:30pm

  • NaturPro Scientific will be discussing common pain points (and reliable cures) to forging long-lasting client-lab partnerships. For example, many companies responsible for testing their product pay little attention to how the material is being tested, and whether the lab is using a scientifically valid method.
  • Miscommunication, lack of transparency, and insufficient lab QC practices can hamper the reliability and consistency of lab test results. Ultimately, product quality suffers.
  • Open communication, verification, and investment in testing of ingredients and finished products are critical factors of successful partnerships in many ways — the main being to prove the validity of test methods required by GMP, and ensure accurate and reliable results.
  • The business benefits of positive client-lab relationships are often reflected in key performance metrics such as fewer production delays and product recalls, and reduced testing expenses.

——————

About the Workshop:

The extensive range of requirements for testing—of ingredients and finished products—places a great burden on manufacturers to invest in their own laboratory facilities, or to select an appropriate contracted partner. Many companies do both, using internal resources for day-to-day operations and outsourcing higher cost tests or seeking independent validation of results. Understanding the steps involved in selecting the right laboratory partner to meet your needs, and managing that partnership over the long term, can lead to greater peace of mind and, ultimately, ensure you’re delivering the highest quality products to consumers.

  • Top considerations and questions for a contract laboratory partner
  • Ensuring your laboratory is compliant with all regulations—and that you’re covered
  • Determining the type of testing that can be accommodated in-house and what is best served by an outside partner.

Speakers:

  • Tara Couch, EAS Consulting
  • Blake Ebersole, NaturPro Scientific
  • Michael Hoard, Arizona Nutritional Supplements
  • Holly Johnson, AHPA
  • Aaron Secrist, NOW Foods

Underwritten By:

American Testing Lab

Eurofins

Micro Quality Labs

Good Manufacturing Practices (GMP) for Natural Products

by NaturPro in Quality Comments: 0

Scientific Publications on Natural Products, including Food, Medicine and Dietary Supplements: With a focus on Good Manufacturing Practices (GMP) for Natural Products, Quality Management Systems, and Good Agricultural and Collection Practices (GACP)

(Have a suggestion to add? Contact us!)

    1. A Field Guide to Herbal Dietary Supplements, AHPA-ERB Foundation, http://www.ahpafoundation.org/fieldguide.pdf
    2. A Harvester’s Handbook to Wild Medicinal Plant Collection in Kosovo (2003). Lonner J. and Thomas M. Source: http://www.gowildconsulting.com/wp-content/uploads/2011/02/harvesters_handbook.pdf
    3. AHPA-AHP Good Agricultural and Collection Practice for Herbal Raw Materials, December 2006. (Updated draft 2016)
    4. AHPA Botanical Identity References Compendium, http://www.botanicalauthentication.org/index.php/Main_Page
    5. AHPA Guidance Policies, http://www.ahpa.org/Portals/0/PDFs/Policies/AHPA_Guidance_Policies.pdf
    6. Aspects of sustainable wild plant collection (2012) Rodina K, WWF Hungary/TRAFFIC
    7. Biological Diversity Act 2002 (India)
    8. BRC’s Global Standard for Food Safety
    9. Canadian Herb, Spice and Natural Health Product Coalition (CHSNC) Good Agriculture and Collection Practices (GACP). Kehler C. Source: https://www.cotr.bc.ca/webs_media/Creston/_docManager/docs/Good%20Agricultural%20and%20Collection%20Practices(1).pdf
    10. Canadian Horticultural Council OFFS (CanadaGAP)
    11. Code of Good Agricultural Practices of Georgia (2007). Ministry of Agriculture of Georgia. Source: http://iwlearn.net/iw-projects/633/reports/aret-code-of-good-agriculture-practices-of-georgia
    12. Code of hygienic practices for spices and dried aromatic herbs. (2014) Codex Alimentarius Commission, CAC/RCP 42-1995
    13. Codex Alimentarius Commission Recommended International Code of Practice – General Principles of Food Hygiene CAC/RCP1-1969, Rev. 4 -2003
    14. Current good manufacturing practice in manufacturing, packaging, labeling or holding operations for dietary supplements (21 CFR 111)
    15. Current good manufacturing practice, hazard analysis and risk-based preventive controls for human food (21 CFR 117)
    16. Development of a Good Agricultural Practice Approach. November 5, 2003. Source: http://www.fao.org/prods/GAP/archive/GAPCONCEPT12_en.pdf.
    17. Development of Good Wildcrafting Practices and Wildcrafter Certification for Medicinal Plants. (2006) Howe A. Source:  http://www.bestlibrary.org/best_teachers/files/Wildcraftingfinalreport.pdf
    18. Dietary Supplement Ingredient Database, https://dietarysupplementdatabase.usda.nih.gov/
    19. Dietary Supplement Label Database, https://ods.od.nih.gov/factsheets/DietarySupplements-HealthProfessional/
    20. Dietary supplement laboratory quality assurance program: the first five exercises. Phillips MM, Rimmer CA, Wood LJ, Lippa KA, Sharpless KE, Duewer DL, Sander LC, Betz JM.  J AOAC Int 2011;94:803-14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3173719/
    21. Dietary Supplement Online Wellness Library (OWL), Council for Responsible Nutrition (CRN), http://www.supplementowl.org/
    22. EFSIS Safe & Legal: https://www.saiglobal.com/assurance/food-safety/SafeandLegal.htm
    23. Ensuring the Compliance of Raw Herbal Materials stemmed from China with European Good Agricultural and Collection Practice. Philippe A. et al. Chinese Herbal Medicine, (2011) 3(4): 251-256
    24. FairWild Standard, Version 2.0 (2010).
    25. FairWild Standards Map. Source: http://search.standardsmap.org/assets/media/FairWild/English/AtAGlance_EN.pdf
    26. FDA Food Safety Modernization Act http://www.fda.gov/Food/GuidanceRegulation/FSMA/
    27. FDA Dietary Supplement Labeling Guide, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm2006823.htm
    28. Field Techniques Used by Missouri Botanical Garden. Compiled by R. Liesner with suggestions from MO staff and others. Source: http://www.mobot.org/MOBOT/molib/fieldtechbook/pdf/handbook.pdf
    29. GAP Production of TCM Herbs in China (2010) Zhang B. et al. Planta Med 2010 76:1948-1955
    30. General guidelines for good agricultural practices: spices. International Organisation of Spice Trade Associations (IOSTA) (2013). Source: http://www.esa-spices.org/download/iosta-gap-final.pdf
    31. Global GAP, http://www.globalgap.org/uk_en/
    32. Good Agricultural and Collection Practices – Guidelines for the cultivation and collection of herbal medicines. (2012) Republic of Kenya.
    33. Good agricultural and collection practices for medicinal plants: Illustrated booklet for farmers and collectors. Source: http://www.dmapr.org.in/Downloads/Illustratedbooklet.pdf
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