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Food and Supplement Claims with Confidence


Labeling laws and truthful claims are not just critical for protecting the consumer, and they also ensure a level playing field for participants. Even during times of stalled regulatory clarity and enforcement, there is still the ‘golden rule’: do unto others by ensuring product labels are truthful and not misleading.

As we know in this era of alternative facts, it’s easy to make a claim, but harder to verify it with facts and science. (Go science.) But science has a problem. Even when fully developed, it rarely provides the full 100% confidence that may be required to change beliefs and opinions. (Boo, science.)

First example: identity claims. Many are aware that the identity of dietary ingredients need to be stated on the product label, and the specification. What is often missed is that verification through analytical tests to confirm identity are required on every batch of dietary ingredients – a minimum requirement under GMP.

Unfortunately, many identity methods miss the mark for validity and fitness for purpose – also a minimum requirement under GMP which tends to be overlooked. But if an ID method does not detect the presence or absence of common adulterants for a particular material, then how is it meeting the minimum requirement? How is it considered suitable for its purpose? In most cases, more work is needed: an adulterants review, developing and adopting multiple methods that determine a material’s identity, and adequate supplier qualification are all keys to providing a more reliable assurance of identity. The ‘totality’ approach to assuring identity is especially helpful when non-specific or indirect measures are used, like those based on infrared spectroscopy or thin layer chromatography.

Health claims also require scientific evidence. (Go science.) Here the standards are more clear, but not without some confusion. It is pretty clear that the U.S. scientific establishment plus judge and jury has decided that animal data, anecdotes and traditional use are not scientific, and therefore are not sufficient evidence to support a health claim. Past that, there’s some gaps in minimum requirements, and ask ten experts to get ten opinions (One or two studies? Published or not?). But most agree that well-designed human studies, with differences in treatment versus control groups different to more than a 95% confidence limit (known as p<0.05) are the path to health claims substantiation. This arbitrary statistical cutoff can be criticized, too, because when p=0.051 (a confidence of 94.9%), a product is deemed no more effective than placebo. The difference is the line between effective supplement and worthless snake oil. This confuses even most scientists, but it does set a pass/fail that can be evenly applied.

Science is becoming increasingly useful in the verification of content claims. Now that analytical tools can quantify at picomolar concentrations, almost down to the molecule, content claims can be powerful and truthful if investments are made in developing and verifying them. On the other hand, content claims are increasingly policed by consumer groups and class action attorneys, so a failure to verify content claims can be painful. In one recent example, the kombucha tea industry has been hit hard by a series of settlements involving mislabeling of alcohol, sugar and antioxidant content, and exploding bottles. Debate over which test methods were suitable for ethanol (one of the most frequently analyzed substances) led to an industry-wide effort to validate a method specific for kombucha. The validation in kombucha compositions was the last step required in order to rule out the slim possibility that kombucha contained unique matrix interferences that could make it difficult to measure with reliability. As a participant in the project, validation results from our partner laboratories showed a GC-FID method commonly used for ethanol in foods and beverages was indeed fit for purpose. After approval by the AOAC scientific expert review panel, the method is now becoming adopted by the kombucha industry as a standard method.

While not all methods require this kind of validation, the process is the key part to pay attention to. First you need to verify the test method. Then you verify the product against the claim you want to use, with the verified test method. Then you can put the claim on your label. In that order.

Here’s another catch about claims: your evidence is only so good as it verifies the claim. Picture an ingredient made on the same manufacturing line as a common allergen. Is a test report and supplier checklist from last year sufficient on its own to prove that a new shipment you just received is allergen-free? Maybe, maybe not. The best test method in the world will not make up for a lack in understanding whether you should reasonably expect the same results with the new lot as you did before. Verification is not just about testing.

Regardless, for those who are interested in verifying label claims, hopefully we can all agree that there should be rules, and the same rules should apply to everyone. What should also be agreed is that whether claims are truthful and misleading should be based on science and facts, not beliefs and opinions. Go, science!

 

By: Blake Ebersole

Published in Natural Products Insider, 2017

 

New Omega-3 Technologies Evolving


Emerging sources and technologies for omega-3, omega-6 and healthy fats:

We didn’t need to add butter to coffee to demonstrate the importance of fats as energy in the diet, but maybe it helped. The concept that there are healthy fats other than omega-3’s and 6’s may present a challenge to market growth. Fortunately, the quality problems that plagued the sector for years have moved on. We no longer need to worry how to clean up fish oil, and make it taste like key lime pie.  But where to go from here?

Hopefully the benefits of omega-3’s will continue to be found from the hundreds of clinical studies in progress.  But no dietary ingredient exists in a vacuum, and there are ways to further optimize omega-3’s beyond the old standbys.  For example, phospholipids naturally present in krill oil have been shown to increase the absorption of DHA, allowing for a lower dose substantiated for phospholipid-rich krill oil. This is nature’s way of optimizing absorption. Both phospholipids and omega-3 are stored in cell membranes, where they serve similar roles.  It is reasonable to think there might be a benefit to consuming both together, beyond the increased bioavailability. Are there better optimized combinations of phospholipids and cofactors which closer represent the nutrient profile of salmon, and may be even more beneficial?  Perhaps.

Meanwhile, man continues to create products based on nature, inspired by milk emulsions and small intestine micelles, developing ways that (at least theoretically) increase the body’s ability to assimilate nutrients.  But some caution is to be given with the re-emergence of New Dietary Ingredient guidance. If NDI’s are to be taken literally, any dietary ingredient having a different composition than one marketed before 1994 requires a notification to FDA. So, it’s probably a good idea to start putting together the safety assessments that will be required for omega-3 ingredients and technologies that were not around before 1994.

Back to the clinicals. In addition to the hundreds already published, there are more than 250 clinical trials listed on clinicaltrials.gov for omega-3, which are just getting started.  You name the health condition and it’s probably represented.  Add on the current study conducted by the U.S. Army, to determine if krill oil improves cognitive performance of soldiers. Out of all the supplements (and likely drugs) possible for a study like this, omega-3’s were selected.  With all this interest, there must be some evidence that the stuff works.

For product development, in case a high-quality omega-3 source is not sexy enough on it’s own, the literature is abound with examples of combinations of omegas with other nutrients.  DHA with EPA and GLA have led to improvements in multiple studies on people with cognitive impairment.  Look for the combinations of omega-6 to be balanced with omega-3 sources like flax and krill. And stearidonic acid (18:4 n-3) from echium and Buglossoides arvensis may be a cofactor to help improve absorption of DHA and other omega-3’s.

Combinations of omega-3 with ingredients that are not necessarily fat soluble may be trending. In a 2014 placebo-controlled study, a probiotic blend and omega-3 combination increased HDL and lowered insulin resistance better than either alone.  The addition of Vitamin E and C to DHA has been researched in clinical trials, and several studies have observed the benefits of statins with omega-3.  Omega-3 blood levels may also affect whether B-vitamins can slow the brain’s decline during aging.  And their addition with Vitamin D has been shown to improve symptoms in people with mental illness. So there is some basis to believe omega-3’s are able to potentiate the effects of both water-soluble and fat-soluble nutrients, likely in different ways.

Our understanding of the relationships between PUFA, fat metabolism and inflammation has created many connections with pathways regulated by other nutrients. Thinking in terms of focused nutrition, a combination of omega-3’s with other sources of healthy fats such as MCT, at a certain dose and balance could provide optimal brain nutrition for certain people.   The addition of other cofactors along the arachidonic acid and inflammatory pathways, in addition to mediators along the endocannabinoid pathways may provide systemic support for the pathways which rely on a steady stream of fatty acids as signaling molecules.

New sources of omega-3 are likely to pop up as they always have. Perilla, new types of microalgae, and plants like canola bred to produce greater amounts of omega fatty acids are in the pipeline.  And a few consumer product categories are starting to emerge as opportunities for fortification with omega-3. Meal replacement powders and liquids are beginning to see omegas being added successfully, benefitting from new powdering and emulsion technologies.  The infusion of omega-3 into food products like eggs, chickens and even prepared foods has been achieved through integration of DHA-rich algae or flaxseed into animal feed.  Thanks to long-term and growing interest, the omega-3 rich products of today don’t look or taste anything like grandmother’s cod liver oil, but are just as healthy.

By: Blake Ebersole

First published in Natural Products Insider, October 2016

References

  1. http://www.hindawi.com/journals/mi/2014/348959/tab1/
  2. http://www.eurekalert.org/pub_releases/2014-05/bawh-nss050114.php
  3. http://www.ncbi.nlm.nih.gov/pubmed/12837515
  4. http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-26492011000400007
  5. http://content.iospress.com/articles/journal-of-alzheimers-disease/jad150777
  6. http://www.hindawi.com/journals/ije/2013/361895/
  7. https://www.army.mil/article/172714/omega_3_study_aims_to_give_soldiers_a_cognitive_advantage
  8. http://www.foodingredientsfirst.com/news/Waitrose-Launch-Omega-3-Rich-Chicken-As-Alternative-To-Unpopular-Oily-Fish.html
  9. http://www.fasebj.org/content/26/1_Supplement/125.6
  10. http://www.ncbi.nlm.nih.gov/pubmed/26793308

Cannabis Quality Consultants

by NaturPro in Uncategorized Comments: 1

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.

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

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Quick Links:

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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)

Cannabis and CBD Experts

by NaturPro in Uncategorized Comments: 19

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

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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

Tainted Supplements Perspective & A Master List of Offenders

by NaturPro in Quality Comments: 113

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 [email protected].  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

Testing Lab and Method Qualification


There are thousands of variations of analytical methods used for natural products.  Not all of them are fit for purpose, failing to meet a central requirement for dietary supplement cGMP’s.

Identity methods for botanical products are especially problematic, as demonstrated by the mass confusion set off by the NY A.G.

And manufacturers and contract labs are stuck in the middle of a supply chain that can lack an understanding of the source or processing method, which are important factors for labs to determine appropriate methods.

The slide deck at the link below is from a 2016 talk at SupplySide West that presented challenges and best practices for method selection and validation against established guidance. A process for laboratory qualification, method development and ‘red flags’ are included in these slides.

Access the slides here

NaturPro Supports AOAC Official Method for Ethanol in Kombucha


NaturPro Scientific presented method validation data leading to a unanimous vote for adoption of first action Official Method status at the 130th Annual Meeting of AOAC International, September 18-21, 2016.

The Official Method status is thought to be the first method to demonstrate scientific validity for ethanol in kombucha under peer review, and is the result of a truth-in-labeling initiative supported by industry.

Kombucha is a fermented tea marketed for probiotic properties, which is expected to continue 25% yearly growth, to nearly $2 billion by the year 2020.

The validation data has been submitted to the Journal of AOAC for publication.

A preliminary validation study, including data from multiple laboratories, is available here. 

NDI, GRAS and Supplement Safety Assessment


The objective of NDI and GRAS  for supplements and foods is to provide a baseline evaluation of the safety aspects of an ingredient.

FDA issued draft guidance on the NDI and final guidance on the updated GRAS requirement in August 2016. The guidances are likely to require a significant amount of information related to safety and quality of dietary ingredients to be compiled and evaluated by scientific experts.

Four Steps to Compliance:

1. Determine the most likely regulatory status of your ingredient:  ODI, NDI, GRAS or other based on a preliminary review of regulatory status and toxicology data.
2. Compile a master file of all your safety and quality documents supporting the new CFR 117 and the new FDA guidances. Most master files are more than a hundred pages long, including references.
3. Have the master file reviewed for gaps according to the regulatory status. Perform a risk assessment to safety, quality or brand presented from the analysis.
4. Chart a plan of action to meet the requirements.
Toxicology and safety studies are expensive to conduct, so you need to know if your ingredients need to go through the new GRAS Notification process, require a NDI Notification, and also carry any specific risk for adulteration or contamination. Take care of these elements, and you can be fairly sure that you will not be blind sided by regulators, consumers, or class action attorneys.

A pre-assessment is typically conducted quickly to determine the appropriate strategy and level of risk.  Contact us to determine the best strategy for you.

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For more detail, here is a framework of basic requirements for a safety assessment

  1. Clinical, Medicinal and Food Use 
    1. In country to market
    2. Global
  2. Regulatory Status
    1. ODI or NDI (if ingredient used for supplement)
    2. GRAS
    3. Other
  3. Toxicity Summary
    1. History of human consumption in foods/supplements including dosage amount and composition
    2. LD50/acute toxicity/chronic/subchronic toxicity studies
    3. Bioavailability and ADME
    4. Clinical trials
    5. Other (genotoxicity, carcinogenicity, reproductive toxicity etc)
    6. Case reports, AER and Drug Interaction Review
  4. Dietary Supplement Manufacturing Risk Review (or CMC, Chemistry/Manufacturing/Control)

    1. Chemical and Nutritional Characterization
      1. Literature review
      2. Specification, Certificate of Analysis, ID and contaminants
    2. Manufacturing Facility GMP evaluation (self-assessment and audits)
    3. Potential adulterants and their controls

Contact us for more information.

Identity Testing for Dietary Supplements

by NaturPro in Quality Comments: 12

The mass confusion around identity testing has brought more awareness to the issue, but the industry is still lacking clear guidance on how to deal with some of the practical issues.

How to Properly Conduct Identity Testing for Dietary Supplements

Verifying identity is like a lot of sciences drawn from multiple disciplines: it’s not usually plug-n-chug, and it requires replication of results to achieve meaningful conclusions. Luckily for science, there are valid ways to determine ID. They just take some thought, and in many cases, more than one test.

The thought behind ID requires some understanding of the context of the material being identified. Species expected, plant part, physical form, likelihood and type of adulterants, degree of processing and concentration all dictate what type of method should be used.

Believe it or not, identity testing is easy for a lot of botanical raw materials. Whole or cut herbs, fruits and roots are often easily distinguished by their quality, and by physical features such as size, shape, color and odor. However, we lose this ability when we take a whole leaf, dry it and grind it into a powder whose parts cannot be identified by microscope. At this point, we have to switch to chemical testing to determine what ancient terminology should be used, using classifications created hundreds of years ago by people for plants.

Luckily, whatever form of ID methods we choose, we still need to compare to a ‘reference’ or a sample of the plant as it exists in nature. So it’s really important to be sure the reference material is authentic and representative of the target species in the population, because it forms the entire basis for the test. The method itself should be based on clear and objective pass-fail criteria that includes at least one positive match to the species expected, plus in many cases for higher risk materials, at least one negative match to rule out a possible adulterant.

The documentation is as important as the activity. If it’s not in writing then it didn’t happen, says the auditor. One shortcut often taken for verifying ID is to write ‘conforms’ on the COA. But what, exactly, does the sample conform with? A memory of what the sample looks and smells like? A powder that has been verified to contain some of the same chemical markers as the expected species, which you are ‘pretty sure’ is 100% of the expected species? Or to a specific authenticated reference material? Because shortcuts on the reference are so often taken, it is best to list the reference material number used in the Certificate of Analysis for the sample, under ID Method. Accompanying the COA and available on request should be a test report which lists all methods, reference materials and their validations and verifications.

How to know your reference material is authentic? The best is to acquire whole fertile plant parts from a source that has authenticated the identity of the sample using a trained botanist or herbalist. For chemical testing, a lower grade of botanical references (milled powder, extract or liquid forms) are often used, but their validity as reference material are considered inferior or secondary in the absence of authentication and chain of custody to the whole plant part.

The difference between trusting the source of reference materials versus verifying it can make all the difference. For example, a bottle of olive oil purchased from the grocery store may be used as a reference standard without verifying the identity with testing. However, olive oil is known to be adulterated with other oils, so our trust in the label should not be sufficient to verify its identity. We need more proof, in the form of independent test reports using valid methods, that the olive oil is 100% from olives and is not adulterated, before we can consider it a valid reference material.

Botanical references, even authentic ones, are not ‘ready-made’ to reference all types of samples from the same species and plant part. Again, this is an area that requires some thought by laboratory technicians. For example, when a botanical is extracted or heated, chemical changes occur. To prevent the processing method from falsely impacting the match, a reference must undergo the same process as the sample, or else the chemical differences from heating falsely appear as differences between the species. So, if your sample was extracted in hot 70% ethanol for five hours, then the lab should prepare the reference in the same way.

Now, for the top 5 ID testing lessons they don’t teach in school:

  1. Much of ID testing relies on a sufficient understanding of the material being tested. Communicate to the lab as much info as possible, such as specification and manufacturing process, so that they can make sure to prepare the reference standards correctly and select the correct method.
  2. No ID method covers all potential adulterations or mis-identifications. And ID covers contamination if it may be considered harmful. Make sure you know what the risks are for your materials. Risk assessment for adulteration is necessarily a team effort across the supply chain, not something that ‘someone else should be doing’.
  3. Authentic references and their preparation are as important (or more) than the method used. Always check the sources and make sure they are authenticated and representative of the species and identity.
  4. Testing the same sample with different methods substantially improves the meaningfulness of any one test. High risk materials with known adulterants often need a test for a positive match to the species and a separate test for a negative match to the adulterant.
  5. Many adulterants, especially newly developed ones, are not caught with typical ID methods, which is why strong specifications, and supplier verification is so important.

The issue of ID is not going away, and it’s a big issue in food now too (see sawdust in cheese, sushi that’s not sushi, etc). The wave of attention on food and supplement ID issues has not yet begun to crest, but now at least we know how to swim.

This article was originally published by Natural Products Insider in August 2016.

Single Laboratory Validation of Ethanol in Kombucha Tea

by NaturPro in Uncategorized Comments: 12

Single Laboratory Validation of Ethanol in Kombucha Tea by Gas Chromatography with Flame Ionization Detection

The objective of this study was to ensure the validity of test results of ethanol in kombucha tea by performing single laboratory validation (SLV) of a method using gas chromatography with flame ionization detection (GC-FID).

Downloads:

SLV Study of Ethanol in Kombucha

Research News: SLV Study of Ethanol in Kombucha

AOAC SMPR