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Supplement Label Consultants

by Morgan Settle in Uncategorized Comments: 0

As Supplement Label Consultants we often are asked what we think of a product claim. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its finished product, or an ingredient or raw material.

The Food & Drug Administration (FDA) has specific rules for labeling and claims related to dietary supplements on packaging, marketing, websites, inserts and other promotional materials. If a label states a false or misleading claim, FDA, other regulatory agencies or class-action attorneys may file warning letters or lawsuits.

Dietary Supplement Label Review Checklist

As Consultants at NaturPro we have a checklist we follow to ensure we help make the label for you product.

⊗ PACKAGING REQUIREMENTS

Five general requirements for labels include: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling (Supplement Facts Panel), 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.

⊗ LABEL STATEMENTS

You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by theconsumer when facing the product), unless otherwise specified by regulation(i.e., exemptions).

⊗ SUPPLEMENT FACTS PANEL

Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, totalcarbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, andiron must be listed when they are present in measurable amounts. Calories from saturated fat and the amount of polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they must be declared when a claim is made about them.

⊗ INGREDIENT LIST

When present, you must place the ingredient list on dietary supplementsimmediately below the nutrition label, or if there is insufficient space belowthe nutrition label, immediately contiguous and to the right of the
nutrition label.

⊗ WARNING STATEMENT

FDA requires warning statements related to safety and special precautions that, if not followed, could make the product unsafe.

⊗ UNITS OF MEASUREMENT

Proper units of measurement must be used, for example milligrams (mg), micrograms (mcg) or other appropriate units

⊗ PERCENTAGE DAILY VALUE (DV)

The % DV must be declared for all dietary ingredients for which FDA has established Daily Values, except that 1) the percent for protein may be omitted, and 2) on the labels of dietary supplements to be used by infants, children less than 4 years of age, or pregnant or lactating women, you must not list any percent for total fat, saturated fat, cholesterol, total carbohydrate,dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum,chloride, sodium, or potassium.

⊗ DOMESTIC ADDRESS OR PHONE NUMBER

The label of a dietary supplement being marketed in the United States must include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. If the label does not include the required domestic address or phone number, the dietary supplement is misbranded.

⊗ UPC BAR CODE

The UPC bar code may be obtained from the Uniform Code Council (www.uc-council.org)

⊗ NATURAL AND ARTIFICIAL FLAVORS

You must declare these ingredients in ingredient lists by using either specific common or usual names or by using the declarations  “natural flavor” or “artificial flavor,” or any combination thereof.

⊗ CHEMICAL PRESERVATIVES

You must list the common or usual name of the preservative, which may be followed by a description that explains its function e.g., “preservative,” “to retard spoilage,”“a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”

⊗ OTHER DIETARY INGREDIENTS

You must list “other dietary ingredients” by common or usual name in acolumn or linear display. FDA has not specified an order that you must follow. You must list the quantitative amount by weight per serving immediately following the name of the dietary ingredient or in a separate column. You must place a symbol in the column for “% Daily Value” that refers to the footnote “Daily Value Not Established,” except that the symbol must follow the weight when you do not use the column format.

⊗ LIQUID EXTRACTS

You must list liquid extracts using the volume or weight of the total extract and the condition of the starting material prior to extraction when it was fresh. You may include information on the concentration of the dietary ingredient and the solvent used. The solvent must be identified in either the nutrition label or ingredient list.

⊗ DRIED EXTRACTS

For dietary ingredients that are extracts from which the solvent has been removed, you must list the weights of the dried extracts.

⊗ CONSTITUENTS

You may list constituents of a dietary ingredient indented under the dietary ingredient and followed by their quantitative amounts by weight per serving. You may declare the constituents in a column or in a linear display.

⊗ PROPRIETARY BLENDS

You must identify proprietary blends by use of the term “Proprietary Blend” or an appropriately descriptive term or fanciful name. On the same line, you must list the total weight of all “other dietary ingredients” contained in the blend. Indented underneath the name of the blend, you must list the “other dietary ingredients” in the blend, either in a column or linear fashion, in descending order of predominance by weight. These ingredients should be followed by a symbol referring to the footnote “Daily Value Not Established.”Dietary ingredients having RDIs or DRVs must be listed separately and the individual weights declared.

⊗ PRODUCT CLAIMS

Claims come in four basic varieties:

  • structure/function claims
  • disease claims
  • health claims and qualified health claims
  • content claims

Basically, dietary supplements cannot make “disease” claims (for example: “treats cancer”). Dietary supplements that make disease claims are considered by FDA as drugs.

Dietary supplements can make “structure/function” claims (for example, “calcium builds strong bones”). A structure/function claim describes the product’s role in maintaining the “structure or function of the body,” or “general well-being.”

The Federal Trade Commission (“FTC”) has overlapping jurisdiction with the federal Food and Drug Administration (“FDA”), and focuses more on whether advertising is truthful, or false and misleading. Thus, it is important to respect nuanced labeling rules, including those regarding the statement of the identity.⊗HIGH POTENCY CLAIMS

The regulation states that the term “high potency” may be used in a claim on the label or in labeling to describe individual vitamins or minerals thatare present at 100 percent or more of the Reference Daily Intakes (RDI) per reference amount customarily consumed (21 CFR 101.54(f)(1)(i)). This means a supplement may be labeled as “high potency” for each nutrient(s) that is present at 100% of the RDI per serving.

⊗ ANTIOXIDANT NUTRIENT CONTENT CLAIMS

A claim that describes the level of antioxidant nutrients present in a food is a nutrient content claim and may be used on the label or in the labeling of a food when the conditions of use in the regulation are met (21 CFR 101.54(g)).

The antioxidant nutrient must meet the requirements for nutrient content claims in 21 CFR 101.54.

⊗SUGAR-FREE CLAIMS

A dietary supplement may include claims in labeling such as “sugar free,” “no sugar,” or other claims provided it meets all of the eligibility criteria set forth in the regulation.

Among other requirements, a food must be labeled as “low calorie” or “reduced calorie” or bear a relative claim of special dietary usefulness. However, a dietary supplement that is prohibited from bearing a “low calorie”or “reduced calorie” claim can still use a sugar-free claim provided it meets the “low calorie” requirement in 21 CFR 101.60.

⊗HIGH OR GOOD SOURCE CLAIMS

You may make a “high” claim when your dietary supplement contains atleast 20% of the Daily Value (DV) (i.e. the Reference Daily Intake (RDI) or Daily Reference Value (DRV)) of the nutrient that is the subject of the claim perreference amount customarily consumed. You may make a “good source”claim when your dietary supplement contains 10 to 19% of DV.

⊗ LOW OR FREE-FROM CLAIMS

If a similar dietary supplement is normally expected to contain a nutrient and your dietary supplement is specially processed, altered, formulated, or reformulated as to lower the amount of the nutrient in the food, remove the nutrient in the food, or not include the nutrient, then you are permitted to make a “low” or “free” claim as applicable.

⊗ LOW CALORIE CLAIMS

A “low calorie” claim may not be made on dietary supplements, except when an equivalent amount of a dietary supplement that the labeled dietary supplement resembles and for which it substitutes (e.g., another protein supplement), normally exceeds the definition for “low calorie.”

⊗ QUALIFIED HEALTH CLAIMS

FDA will permit the use of a qualified health claim provided that 1) FDA hasissued a letter stating the conditions under which we will consider exercisingenforcement discretion for the specific health claim, 2) the qualified claim is accompanied by an agency-approved disclaimer, and 3) the claim meets all the general requirements for health claims in 21 CFR 101.14, except forthe requirement that the evidence for the claim meet the validity standard for authorizing a claim, and the requirement that the claim be made in accordance with an authorizing regulation.

This guidance was prepared by the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.

Further reading:

Article: Food and Supplement Claims with Confidence

Food and Supplement Testing for Natural Products

Dietary Supplement Facts and Label Review FAQ

Dietary Supplement and Food Label Review

Cannabis Quality Consultants

by NaturPro in Uncategorized Comments: 0

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

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

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

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

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

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

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

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

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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: 0

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

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

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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

Single Laboratory Validation of Ethanol in Kombucha Tea

by NaturPro in Uncategorized Comments: 0

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

 

Why Verify, Then Trust?

by NaturPro in Uncategorized Comments: 0

“Verification” is the 2016 buzzword for food and supplements, due to the sequence of food safety crises that arguably started with salmonella in peanut butter in the early 2000s.

Recently, FSMA and the “Identity Crisis” for botanical ingredients in supplements have renewed the requirement for verification of quality and safety practices in the supply chain: raw materials, manufacturing practices and test methods being three big areas of focus.

“Trust But Verify” is attributed to President Reagan and later FDA and quality assurance folks. Although it is a well meaning mantra, doesn’t it make verification seem optional?  Shouldn’t we verify BEFORE trusting?

We do know that trust disappears soon after a failure to verify becomes apparent.

From Salmonella in peanut butter, to misidentified plant extracts, to illegal levels of contaminants in your food or supplement, verification is how trust is ensured.

While trust is the ultimate goal, verification comes first.

#verifythentrust

First published on LinkedIn, April 2016

2-Minute Tip: 6 Ways Ingredients Communicate Value

by NaturPro in Uncategorized Comments: 0

Product development is an increasingly painful process, taking weeks and months to sort through and evaluate ingredients.

That’s because the evaluation process involves cutting through the marketing fluff and understanding (and communicating) the core value of your product.  This makes it a difficult and time-consuming task for your customers.

Marshmallow fluff GinnyWhy should your customer pick your product or ingredient over all the others?  Because they are able to communicate it’s value.

Effective customer education  is one great way to help customers navigate the pitfalls of the product development process, and keep your product top of mind.  The results often include higher customer conversion and less wasted activity.

 Here’s a 2-Minute Tip listing a few things to be sure to include in your customer education materials:

2-Minute Tip: Six Ways Ingredients Communicate Value

 

 

What do supplement testing and Star Wars have in common?

by NaturPro in Uncategorized Comments: 0

Star Wars and science fiction fans know that technology is a double-edged sword. On one hand, advances in science offer us fantastic powers to solve difficult problems (space travel, light sabers). On the other hand, the potential for catastrophe is also greater. With better technology comes a greater responsibility to prevent its misuse.

Early botanical scientists understood both the power and limitations of science to describe a complex natural world. Carl Linnaeus, who developed the original system to classify plants and animals, recognized that all organisms are not discrete species necessarily, but exist on a continuous spectrum of life.

Five ways NaturPro helps to ensure scientific validity

star-wars-episode-7-production-release-date

Today, scientists in academia work to identify and quantify the diverse array of chemical constituents in botanical products, while industry works to ensure a safe, effective and consistent product. At our disposal are alphabet soups of various analytical technologies that offer increasingly better detection of constituents, even down to the picogram, which relative to a gram can be visualized as a drop of water in a thousand swimming pools.

But with picoscale resolution comes a lot of noise (one trillion per gram, to be exact) and even more responsibility to reliably separate a signal from it. Even at the parts-per-million (ppm) level—equivalent to a cup of water in a swimming pool—we often observe unexplainable results that defy logic.

How our “UnLab” approach controls for shoddy methods and unexplainable results… 

For example, only today’s best and most expensive instruments, such as multiple mass spectrometers linked to a chromatograph, such as LC/MS/MS (also known as tandem-MS, which means two mass spectrometers are hooked to each other; the first MS removes a lot of the “junk” that can interfere with the result from the second MS), are able to account for matrix effects that occur when testing complex mixtures. The reason complex mixtures are so difficult to examine is they contain so many different compounds, and therefore the chances are relatively high that one of these is observed at the same retention time (or peak) on the chromatogram as the compound a scientist is trying to quantify. Also, because the sample is being injected into super-heated, high-pressure instruments, there are often chemical reactions create new interfering compounds. Matrix effects can falsely change results in a significant way that cannot be resolved without further work. Results should always be questioned and replicated, and ultimately, investments in the development of methods are required to generate confidence.

FDA Supplement FactsValidation of matrix-specific methods across multiple laboratories address these challenges, however few methods have been validated to the extent required to be confident in the results. An example from the nutrition field: the inherent challenges in quantification of vitamin D (a pure compound and age-old vitamin, no less!)

Both the best and worst thing about good science is that with each answer comes another question. There is always more work to be done to achieve the greater goal: reproducible results. Needless to say, rigorous analysis of complex mixtures such as botanical products is often not straightforward. Unfortunately, the aims of science often oppose the aims of high-throughput lab testing.
How do you know whether a lab is focused on getting the right results? Here are some criteria to help decide whether or not to work with an independent laboratory:

  • Is it transparent? Does it share methods, chromatograms, observations, historical data and control charts?
  • Does it perform validation? Does it verify methods using appropriate controls such as calibration curves and spike recovery? What steps are taken when it initially sets up a method?
  • Does it have a process for dealing with out-of-specification results, and will it share that process? Does it have an internal recordkeeping system that tracks method precision and alerts them when a method or system is out of calibration?
  • Does it run internal control samples? Does it run samples in triplicate or duplicate at least, and does it report statistical analysis on the certificate of analysis (CoA), such as standard deviation from multiple runs?
  • How does it validate the purity of reference standards? When it gets a new batch of reference standard, does it run it against an internal control sample? How often does it make fresh reference standard solution?
  • Is it a proactive communicator, for example how often does it advise on the best methods to use, and alert their customers on new developments in methods?

 

Not all testing needs to be expensive or high-tech, but every method needs to be rigorous enough to provide results that are reproducible in another lab. For example, thin layer chromatography (TLC) is not high-tech, but it can be valid to determine botanical identity with the right mix of expertise, a rigorous and validated set of reference standards, and enough trial and error to develop the method and be confident in reproducibility of results. High-performance liquid chromatography (HPLC) is great when actual validation of the method and reference standards have been certified for their purity.

MicroscopeThe true test of scientific validity is when multiple labs running different methods achieve the same result, especially when they are blinded as to the expected result.

Despite all of the challenges in quality control (QC) testing of botanicals, the world is changing, and our industry is rapidly improving. With scientific validity mandated by supplement GMPs (good manufacturing practices), and increasing demands for transparency and validity from all stakeholders, everyone is upping their game. Good science, not science fiction, provides reproducible results we can all be confident in.

Learn about reproducible results through our UnLab…


By: Blake Ebersole

This article appears with revisions, and was originally published in the March 2014 issue of Natural Products Insider.

QC Testing Consultants for Supplements and Foods

by NaturPro in Uncategorized Comments: 0

We are QC Testing Consultants for Supplements and Foods.

NaturPro offers independent quality control analysis and testing for foods and dietary supplements.

Why Testing is Important: Supplement and natural product testing with a compliant laboratory is required by FDA for foods, dietary supplements and ingredients to ensure they meet standards for safety, quality and effectiveness.

For example, identity, potency and purity are quality control parameters needed to legally sell a natural product as an ingredient, food or dietary supplement.

Have food or supplement testing questions? Contact Us..

Supplement Food Testing Consultants
NaturPro specializes as the UnLab — expert supplement and food testing consultants who work for our clients — not for a testing lab.

NaturPro Scientific is driven to achieve the right answers for our clients.  

Some have even called us the ultimate UnLab.

We are not a lab. And this independence means that we are free to pick from the top scientific experts for each type of test or analysis. 

As a result, we are truly able to work on behalf of our clients, to ensure that correct methods are used and reliable results are obtained.


Natural Product and Supplement Testing Consultants
Food and Supplement Testing Consultants

Objectives of QC Testing:

  1. To ensure analytical methods used are valid and fit for purpose
  2. To make sure laboratories don’t take shortcuts with your sample
  3. To determine if results are precise and accurate
  4. To replicate the results of another lab
  5. To resolve out-of-specification test results
  6. To resolve disputes in data reports
  7. To determine if “dry-labbing” may be occurring
  8. To have an independent expert to review methods and results
  9. To perform due diligence on a supplier or partner
  10. To eliminate the potential for perceived conflict of interest when testing own products
  11. To qualify a lab as a good partnership choice.

3 main benefits of food and dietary supplement QC testing consultants:

  1. Better analysis and testing validity  for reliable, replicable and defensible results.
  2. Fast turnaround and lower testing costs.
  3. Reduced retesting, rejections, production delays and product recalls.

We know the shortcuts that testing labs can take, and how to prevent that from happening to you, to ensure testing gives the most scientific, accurate and defensible results possible.


Contact Us with your QC Testing Questions

Eight Steps to Developing Research Relationships

by NaturPro in Uncategorized Comments: 0

Developing relationships with scientists is much like any other; the first step is in understanding scientists’ challenges and needs. Sensitivity to the ways of the scientific research world, especially academia, is one of the best ways to get the most out of your research investment.

As for what else a supplement manufacturer needs to do:

Show an interest in the science. Like anyone, scientists can sense if you’re more interested in doing great science or just the marketing benefits from it. Offer solutions that boost both scientific and business objectives. Add to the debate and question assumptions.

Try to discover something new. There are thousands of questions to be answered and thousands of different study designs. To be industry-relevant, adopt “standard” methods used widely—but allow some space for new discoveries. Also, test some new hypothesized bioactivity or clinical effect.  One-hundred percent “me-too” science just isn’t very interesting to scientists or consumers. Plus, new findings are more likely to go viral.

Decide on a budget and be realistic. Most research costs money, unless you can get into a study funded by someone like the NIH. But government funding is decreasing every year, while grant applications have multiplied exponentially. Performing strong research often requires expensive labor and materials, and the coordination of many different shared resources.

Offer unrestricted grants for basic research. Research seeking to understand mechanisms of action often best developed step-by-step, making long-term planning difficult. Unrestricted grants that don’t guarantee a specific study plan allow you to support critical shared resources, and they prevent you from painting yourself into a corner at the beginning of your scientific journey.

Agree to milestones for projects, but anticipate delays. University-based, public-funded research requires the alignment of many parts, so some projects hit snags. Plan in advance to prevent potential troubles with approval, recruitment, testing, or finances. Add a “delay buffer” to your timeline for a more realistic expectation.

Decide whether to publish research results and, if so, where. Agree early on who owns the data and who has final decision on whether to publish results. Deciding this early on is a good idea because it sets the standard for the rigor of study design. It’s not necessary to always publish in a patent application or journal. Consider the fact that by publishing, you are likely helping both humankind and your competition. Decide which one outweighs the other.

Presentations at research conferences are sometimes a good idea because you can “publish” data that is somewhat peer-reviewed, and isn’t widely available to the public.

Scrutinize everything. Analyze all methods, data, and reports closely; question them to the best of your ability. Form an internal peer review panel of experts from related disciplines. Be sure to give yourself and other sufficient time to review and discuss revisions.

License technology. Many universities have inventions or start-ups that quietly clamor for attention and funding. Look for available technologies that are scalable and offer a new benefit for humankind.

By: Blake Ebersole

First published in Natural Products Insider, December 8, 2015

Keys for Meeting Supplement GMP Testing Requirements

by NaturPro in Uncategorized Comments: 0

A core concept across GMPs for many industries is scientific validity, and this is also one of the necessary requirements of the dietary supplement GMPs. For example, the purpose of an ingredient specification is to disclose scientifically valid methods and results for the tests, and these methods and results are used to verify the quality and identity of the material being sold.

Scientific validity means that tests must be suitable for what they are intended to measure. In a rapidly evolving industry, scientific validity is a core principle guiding our efforts to ascertain the identity, safety, and label claims of the material that millions of people take to support their health.


Here’s some ways NaturPro helps to ensure scientific validity


To apply scientific principles to the measurement means that we develop a foundation of confidence in test results that accumulates only through repeated testing of viable hypotheses. During the process, we understand that like with many scientific measurements, sources of error exist which tend to increase with complexity. For example, complex samples containing thousands of chemical constituents (e.g., botanical extracts), and instrumentation methods that have a lot of variables all contribute to our bank of “known unknown” and “unknown unknowns.”

Testing using any single method can be an educated guess as an answer to a different question, especially for labs that may only sporadically test a given matrix with a single type of test.

gel electrophoresisToday’s analytical technology to measure analytes in complex mixtures is way ahead of the not-too-distant past, but now we understand a mitigating factor: that with greater power and resolution comes an increasing number of factors that may cause test results to be inaccurate or imprecise.

For example, it can be difficult to account for systematic error associated with dirty chromatography columns or non-optimal instrument conditions. Inaccurate purity data on reference standards (due to either inaccurate standard purity values, or unaccounted-for degradation during storage) are also a common sources of error — when we are simply trying to figure out the “actual” composition of a material. Another source of error arises from the calculation of the results; for example, moisture can account for a certain amount of the measured weight of both samples and standards, which is often simply estimated, even if it is accounted for.


What more does supplement testing and Star Wars have in common?


Other sources of error in testing can be chalked up to incomplete extraction and isolation during the sample preparation.  The subject of dissolution is an interesting one. For example, it is a common assumption that when a sample “dissolves” during HPLC sample prep, then it is fully “ionized” and thus is not strongly bonded to any solid particles (which then often get caught on the filter and not pass into the detector).

If both standard and sample dissolve to the same degree, no problem!  But (unknown unknown) error due to lower than expected ‘percent recovery’  creeps in when your sample is prepared with heat and time, becoming different compounds and binding differently to the protein-fat-and-sugar matrix of a biological product.  So the analyte that you are trying to extract into another phase is often a lot easier using the pure, unbound. chemical reference standard — leading to a difference in percent recovery.  So chemical reference standards are best complemented in testing with an additional control being the original, authentic botanical reference — yes a whole plant part, taken from the same source as the raw material in question.  Sounds easy, but its actually not for a lot of people. 14963749580_49e4e7ed8a_k

Then compound the sample preparation challenges with the high heat and pressure applied by an analytical instrument like HPLC, where more chemical reactions can happen in the complex sample to degrade what you are measuring, all while your pure reference standard survives nicely to the detector. (Theoretically, this scenario can also happen the other way around, where the matrix stabilizes the analyte better than the standard solution under the HPLC conditions.)

Good-Manufacturing-PracticesExciting stuff, all this mystery, which we eventually find answers to through validation and repetitious testing.  While it’s difficult to predict analytical uncertainty, the point is to control it to the extent possible, hopefully to within 5-10% of your expected result — not bad compared to the 20% tolerance limit required by pharmaceuticals.

The practical question facing suppliers and manufacturers is how to ensure your specification accounts for testing variance?  One solution commonly opted for in the short term is surprisingly simple: add the testing variance to the label or spec requirement, to ensure a high statistical probability that the material won’t fail due to inherent imprecision of the test.

The implications of an imprecise test often means that manufacturers are forced to add an ‘overage’ of material, which essentially makes the cost of the material 10% more expensive for every 10% difference in test results. 

Scientific validity in QC testing for supplement all too often is discussed not on a daily basis, but when the cost of “mistakes” has finally sunk in.  Many a product formulator saw hours and months of work go down the drain due to quality testing failures, and everyone involved in product development can testify to the measurable waste of time and resources that result from testing failures, which can include both the approval of bad material, as well as the rejection of good material.


Five ways NaturPro helps to ensure scientific validity


Here is a short list of some practices that QC units can perform to achieve scientific validity as per GMPs:

–Review your lab’s methods for their suitability for the intended purpose. There are good independent labs out there that will share method information, and answer your questions. Always ask whether the sample is being tested in triplicate and request to receive the individual values.

–Review the documentation on the reference standard, specifically the methods and results of the testing used to determine its purity. When was the standard made, when was its purity last tested, and how was it stored in between?

–Blind your sample so your lab does not know what value to expect.

–Test control samples (samples that do not contain the suspected analyte, OR samples that you previously sent to the same lab).

–Work with labs that can demonstrate having worked to some basic degree to optimize/validate the method.

Sounds like costly work, but not so much when put in perspective of the potential costs. With transparency among customer, supplier, and lab together, a little teamwork goes a long way to reduce the costs and maximize the benefits of quality systems.

By: Blake Ebersole

This article was first published in Natural Products Insider in June 2013