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Quality is as Quality Does

Quality Assurance Quality Assurance

Re-examining dietary supplement ingredient quality in a supply-disrupted world.

Non-GMO Project

Our expert panel:

Daniel Fabricant, PhD, President and CEO, Natural Products Association (NPA), Washington, D.C., www.npanational.org

Salma Fathalla, Director, Quality Assurance, Nutrition21, Purchase, NY, https://nutrition21.com

Dan Lifton, President, Maypro Ventures, Purchase, NY, www.maypro.com

Vishal Shah, Director, Nutriventia, Mumbai, India, https://nutriventia.com

William Sommer, Vice President Global Development and Regulatory, NattoPharma, Oslo, Norway and Edison, NJ, www.nattopharma.com

Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com

Quality. From an ethical standpoint, it would seem that all suppliers and manufacturers would want optimal quality, if not for end-user value then for liability insurance, at the very least.

But suppliers aren’t always transparent and manufacturers aren’t always aware. Therein lies the rub.

That’s why we turned to our panel of experts to suss out what’s vital and what’s not regarding quality for dietary supplement ingredients.

NIE: How do you (or how does your company or organization) define “quality” with respect to nutritional ingredients?

Sudberg: They say beauty is in the eyes of the beholder. Similarly, quality can be in the eyes of the beholder, but first look for that spec.

Specifications should be set in advance of all testing. This makes testing for the quantity of THC or CBD or resveratrol very simple. It either meets spec or it does not. Identity testing is far more complicated and even nuanced.

Gertrude Stein said, “A rose is a rose is a rose,” but the industry relies on Alkemist Labs when they want to be confident that it is indeed a rose, and be able to prove it.

Botanicals have data points that vary based on growing conditions, harvest conditions, drying conditions and region, and further impacted by extraction conditions. With DNA testing or some of these new magic-box tricorders like plug and play devices, a rose is a rose is a rose and labs using that technology might pass substandard quality material because the investigation was too narrow.

Alkemist Labs deploys HPTLC (high-performance thin-layer chromatography), which allows the full offering of the plants phytochemical fingerprint to be debuted in a colorful chromatogram which can then be compared to many reference samples, ensuring accuracy.

We don’t just pass your elderberry based on the presence of one data point or it being a genetic match, we use multiple data points and consider the experience the plant had along the way to its present and potentially questionable state. There is a quality story that hides in the identity story and we assess both together. Our clients are sure they are working with or selling authentic, quality ingredients.

Fathalla: Quality ingredients are the building blocks for a quality finished product. A consistently efficacious, safe, science-backed product is a quality product. Further, proper documentation and accurate SOPs (standard operating procedures) that comply with cGMPs (current good manufacturing practices) make for a solid QMS (quality management system) that is critical in producing quality ingredients. At Nutrition21, quality is of the utmost importance. Our customers rely on us to consistently provide science-based, high quality ingredients that will take their products to the next level.

Shah: Quality is part of our DNA at Nutriventia and touches every aspect of our organization. A commitment to quality branded ingredients is as much about the ingredient itself as the manufacturing process, plants, and people, to the value we provide our customers at Nutriventia.

Quality starts on the backend with sourcing trusted and tested raw materials with uniform manufacturing to provide our customers dependable branded solutions with batch-to-batch consistency. We ensure our products are safe and meet their intended targets, whether a technical advantage or specific efficacy requirements, then provide the support needed for a reliable customer experience.

Fabricant: For starters it’s what’s in the cGMPs: Identity, strength, composition, potency, purity and anything else that may be relevant. Then if there are claims about the ingredient, the expectation for quality is that there is something there to back it up.

Lifton: Our mission statement speaks to both safety and quality: “By supplying safe, natural, highly efficacious nutraceutical ingredients and fine chemicals to the U.S. and global markets, our customers are able to formulate finished products that make a real difference in people’s lives.”

If it’s backed by science, not just me-too window dressing, and is both safe and effective, then an ingredient is at least worth our consideration—but only after those other conditions are met.

NIE: We’ve heard the complaint that “COAs” aren’t (sometimes) worth the paper that they’re printed on. If this is even partly true, why is this the case and what specific steps or choices can manufacturers take to not be handed worthless COAs?

Fathalla: If you’re talking about “fake COAs” (certificates of analysis), you should know you have one prior to completing the qualification of the supplier (if you are doing it correctly and thoroughly!).

A lot of times, companies request COAs for their paper-based document system for receiving. However, once a manufacturer is qualified through proper questionnaires, audit, document requests and testing multiple products, a COA’s accuracy should no longer be an issue (until re-qualification time). Unless you have a validated electronic document management system, paper originals of COAs are required per cGMP regulations. That being said, electronic scans of original COAs can be a good alternative to save trees.

Nutrition21 verifies testing of the all results by a qualified lab to ensure good, specification-meeting data for each attribute listed on the COA as well as provides transparent COAs, complete with all testing and method information. Manufacturers should look out for generalities in COAs, inaccurate methods, and confirm the results.

Sudberg: For too long that statement has been true. Which is why nearly 25 years ago Alkemist Labs set out to provide the most informative COA the industry has to offer, with reproduceable methods transparency. To date we provide, at no additional fee, a fully transparent COA suitable to defend the quality or identity of your ingredients in front of an FDA (U.S. Food and Drug Administration) audit or even court room. This makes our COA worth the value of the material we are testing and not the paper it’s printed on. Also we stopped printing on paper a long time ago and now only offer PDFs. Sommer: COAs are not product descriptors, but report on key values that confirm the quality of the ingredient/product.

It is possible that unpurified natural components are variable mixtures of components, but these are better described by properties, not a composition.

What is inconsistent among suppliers of the “equivalent” ingredient is the definition of what is the functional ingredient and care must be taken when comparing the description of ingredients.

Lifton: COAs are just one piece of the supply-chain chain-of-custody and validation process, but should never be the only documentation relied upon by manufacturers.

NIE: Using the correct method of analysis for ingredients is important. How can manufacturers ensure that the correct methods have been used?

Sudberg: While cGMPs require us to “use some science,” they failed to be specific about what test methods. As a result, results will vary from lab to lab and method to method. So how do you know your lab is using the most fit for purpose method to test your materials? 1) Ask them how they choose their methodology. 2) Rely on AHPA (American Herbal Product Association) and their expert staff and members with their deep level of knowledge. 3) Hire a respected consultant to help set up your testing regime to be able to answer this exact question. 4) Work only with labs that have excellent reputations for proficiency and ISO accreditation for the testing area appropriate to your needs.

Shah: Testing parameters play a highly important role in determining the quality of our products. Test methodologies should be provided by the supplier and may be validated through third-party labs. Hence, testing must be performed diligently against the correct methods and then validated for the molecule of interest.

Fathalla: Manufacturers should check for, and work with their testing labs to check for, existing compendial methods such as USP (United States Pharmacopeia), AOAC, FCC (Federal Communications Commission). The method(s) used should be properly validated for the attribute being tested and run against a standard.

NIE: Microbiological and toxic metal testing of ingredients is also critically important. What are the best practices that manufacturers and suppliers should follow in this regard?

Fathalla: In terms of microbiological testing, basic TPC and YM (total plate count and yeast and mold) should be done on every batch. Micro “load” can vary based on the source of the ingredient (geographically) and type of ingredient (botanical, synthetic, etc.) In addition to that, the basic pathogens such as E. coli, salmonella, pseudomonas and enterobacteria (which covers all gram-negative bacteria) should be included.

When it comes to toxic metals testing, the four basic tests that should be done on every product include arsenic, cadmium, mercury and lead. Other metals may need to be tested based on where the ingredient is sourced, and the manufacturing process; an example of this would be hexavalent chromium.

Shah: A product is deemed to be unsafe if it contains harmful microorganisms or toxic chemicals. It is therefore important for manufacturers to do everything that they can to ensure that these harmful substances are not present in the product, or that they are effectively eliminated.

This can be achieved by following good manufacturing practice, regulations specified by the government for specific products and by having analytical techniques that can detect harmful substances. In many situations it is important to use analytical techniques that have a high sensitivity, by which one can reliably detect low levels of microbiological or toxic material.

Sommer: Follow published standard or compendium methods or logical variants on the representative test sample. Ultimately, what is being confirmed is the absence of, not quantity of.

Fabricant: One thing that is getting more important for micro is to re-calibrate your in-house testing by either checking with a top-flight contract lab or developing a reliable way to sequence to differentiate if a positive has pathogenic potential. For heavy metals, we all have to unfortunately deal with what’s going on in California with Prop 65, so methods have to dovetail into that.

NIE: Ingredients being substituted with cheap alternatives is a problem of economic adulteration. How widespread is this problem, and, briefly, how can manufacturers avoid being duped?

Lifton: Since the incentives for economic adulteration are high, and the difficulty bar for engaging in adulteration is low, this has become a big problem. This makes it even more important for manufacturers to partner with suppliers that they trust and which have a proven track record in the industry.

Fathalla: We have seen a rise in substitution of ingredients for a cheaper alternative over the years. I have mostly seen this in the botanical space. That being said, a solid testing plan for every ingredient you purchase is critical. Make sure that if there is a compendial method, and use that first. Tests such as GC (gas chromatography), HPLC, IR (insulation resistance) are all good at identifying the ID of an ingredient.

Shah: Adulteration has become a serious problem and the reasons may vary, but often it is due to high-priced products, limited supply or lack of clear understanding of the value of higher priced ingredients. Ingredients are substituted or diluted with cheaper alternatives. Thus, adulteration can be avoided by setting an ingredient standard and to partner with reputable suppliers.

It is inevitable that there may be some variation in natural botanical ingredients, even from the same supplier from batch to batch or from month to month, and so it is important that this variability be characterized and monitored to ensure it remains within the given limits. This is where the analytical technique and sensitivity will play an important role as well.

Sudberg: We enjoy the best cross section of the industry in terms of our client base and don’t see too much duping, but it happens. Labs with the kind of experience we have known the tricks of the trade, and what to look for, and there really is no substitute for a high level of expertise. Manufacturers can avoid ending up with worthless or problematic material by entrusting labs with experience and transparency to test things the correct way.

NIE: It is said that quality is not only about safety and efficacy but also about reliability and consistency in color, flavor and other factors from batch to batch. Please comment.

Sudberg: Our clients set specs and we try to make sure they are getting what they asked for. If all they care about in their green tea powder is that the caffeine spec is met, they could be trading saw dust fortified with caffeine, and they are probably not going to the best labs. Sometimes color can vary, and when botanicals are highly processed, they could be almost anything. Aspects of botanicals can vary from season to season and region to region, which is why we test against several different verified reference materials when confirming identity.

Shah: All processes should be standardized to get batch-to-batch consistency and to, thus, ensure a high-quality finished product. The main challenge with botanical raw materials is the seasonal variations of actives. This can be standardized by using chromatographic fingerprinting (TLC/ HPTLC), widely used to characterize the chemical composition of botanical extracts.

Quality at Nutriventia covers a broad range of product attributes in addition to safety, stability and efficacy. We strive to give our customers a reliable experience with no surprises. Our branded solutions assure consistent batch-to-batch characteristics, including color, flavor, particle size, flowability, documentation and applications.

NIE: In many ways, quality is also about the science. Please speak to why, and in what specific ways, having relevant science behind ingredients is so important?

Sudberg: Quality is absolutely about science and, as a lab, we try our best to measure it. What makes good green tea can be determined by its destination. Some are simply looking for high caffeine content. Some may seek a full spectrum of phytochemicals. If a manufacturer is buying an ingredient backed by research based upon a set percentage of a specific constituent, it’s important to confirm that this material is indeed what will be in the bottle with that claim on the label.

Shah: Now, more than ever, science plays a significant role in the dietary supplement and functional food and beverage markets. Delivering quality and value to our customers means understanding what their customers—the consumer—want and need today and tomorrow and developing innovations to address the market. Nutriventia dedicates tremendous resources around developing claims and building the relevant scientific substantiation to support these claims.

Fabricant: The promise of the industry is in our ability to communicate with the consumer. If our message isn’t based on competent and reliable information and data, we wouldn’t have the consumer following and trust that we do and have had for so long.

Sommer: Ingredients do vary in source, composition, formulation and even identity; and these have an effect on performance. “Science” is the unbiased way of quantifying performance, and no nitamin K2 as MK-7 on the market has the body of scientific evidence that MenaQ7 does supporting and confirming performance.

Lifton: Every proprietary ingredient we sell must have human clinical studies supporting it, otherwise we won’t sell it; it’s that simple.

NIE: With all of the focus these days on clean labels, inactives are scrutinized by consumers as closely as actives are, in some cases more so. Please comment.

Sudberg: The next generation of consumers are growing in awareness beyond their predecessors. They ask more questions and want to know more about each ingredient, why is it there, what’s it do, and how do we know if it’s good. So even inactives are being challenged, and so if a brand holder doesn’t jump on the transparency movement, they will find themselves an irrelevant brand.

Fathalla: Visibility and transparency of your inactives has become more important more recently because of the rise in studies showing the unsafe or harmful effects of certain colorants and excipients. In addition to safety, lifestyle needs such as gluten free, allergen free, gelatin/animal derivative free have caused “inactives” to be scrutinized.

Lifton: As well they should be. Whenever and wherever possible, Maypro seeks to offer ingredients that are non-GMO (genetically modified organism), kosher, halal, gluten free, dairy free and other attributes that are important to quality and important to customers.

Fabricant: Yes much of it has to deal with both consumer understanding of “green” and “corporate social responsibility” so for some it’s not enough that all that care is taken with the actives but with the totality of the product, from recyclable plastic, to renewable sources of cotton, to organic excipients, where appropriate, the consumers want to know the source. They want total confidence with the products that they buy represent their values throughout.

NIE: Quality is also linked to sustainable and ethical sourcing. In what ways does sustainability support quality?

Shah: Sustainability is one of the pillars that defines quality at Nutriventia. Sustainable and ethical sourcing practices ensure incoming raw materials are available consistently in terms of quantity and quality. At Nutriventia we have also incorporated sustainability practices into our manufacturing operations regarding waste treatment and restricted solvent usage, thus ensuring that sustainability and quality go hand in hand for every product from Nutriventia.

Fathalla: A company that is responsibly-sourcing will “impress” the consumer. “Quality at the source” refers to an approach in which workers are given the authority to stop a production line if there is a quality problem. Empowerment is also a primary pillar in promoting supply chain sustainability. The promotion of an informed, participatory workplace helps ensure fair working conditions and will likely drive quality improvements.

Sudberg: There is a massive and unstoppable movement toward sustainability through regenerative agriculture. Not only has the jury returned to state that sustainability is important for our futures, it also is important to the quality of your ingredients. With the adage, garbage in garbage out, if you grow your herbs in crappy soil, the secondary metabolites people depend upon for benefits will be of poor quality and so will your sales.

NIE: For suppliers and manufacturers, briefly what is the most important quality differentiator that sets your ingredients apart?

Lifton: Having all of our proprietary ingredients backed by clinical science is a very important differentiator.

Sudberg: We’re not just a testing lab, Alkemist Labs is a purveyor of data. That’s our product. It’s confidence in your ingredients or your product that we sell. Since in the golden triangle paradigm you can only pick two, our value propositions are quality first and turn around time second. There are other labs to work with if low price is your primary concern.

Shah: Nutriventia delivers differentiated ingredient solutions to help our customers meet consumer demands, from low dose, bioequivalent curcuminoids with proven low-dose efficacy to controlled-release long-acting vitamin C to support immunity. Our technologies and science set us apart from other ingredient suppliers.

Fathalla: Going above-and-and beyond by having a thorough testing protocol for every batch of product, and verifying all the attributes for ID, potency, efficacy, biological contaminants, metal contaminants … every time.

NIE: Briefly, in what ways have COVID-19 supply-chain disruptions impacted the ability of a manufacturer to assure quality?

Fathalla: An increase in qualifications for secondary and tertiary suppliers has needed to happen quickly to avoid supply-chain disruptions. This puts more strain on the quality department to assure that the alternate suppliers are providing ingredients that are meeting all specifications.

Sommer: Only qualified and approved starting material, ingredients, excipients and services from specific suppliers, manufacturers and service providers are used to provide a complete quality product and service. With restrictions placed in response to COVID-19, longer lead times caused by the unanticipated disruption in supply and/or time needed to qualify alternatives impacted is impacting consumer access to the products they want.

Lifton: For Maypro, it has not impacted our ability to assure quality. I think that for all suppliers, however, the pandemic has caused disruptions in the availability of ingredients ready for shipment.

Shah: Widespread disruptions in our normal activities brought on by COVID-19-caused global lockdowns and travel restrictions have impacted the ability of some manufacturers to assure consistent quality. At Nutriventia however, our strong quality management system has insulated us from this scenario. Our quality management system is the cornerstone of all our activities, right from product design to manufacturing to marketing, and it ensures that there are adequate fail-safes built into the system be it with regard to multiple approved and audited and trusted raw material sources or back ups in our operational capabilities.

Sudberg: With demand up and transportation options limited and more costly, manufacturers that don’t have solid relationships with a set group of previously vetted suppliers have been scrambling to get enough material. We all know that when demand is higher, adulteration becomes a greater risk. The solution is always to test, test, test. If you work with top-notch testing labs, no supplier can fool you with sub-par material.

Fabricant: For the responsible manufacturers, I think there have been delays which can affect operations but which shouldn’t do any long-term damage. For the folks who introduced a brand during the pandemic, how reliable can their supply lines be without the ability to visit a facility; that’s where the potential for damage to the industry exists. NIE

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