In the U.S., dietary supplements and their ingredients are subject to a patchwork of regulations, industry guidances, voluntary certifications, and audit programs.  With some exceptions, few of our standards have been developed with expert consensus and then broadly implemented by industry. FDA’s dietary supplement Good Manufacturing Practices (GMP) are part of the exception, and have made today’s supplement products generally a higher level of quality than at any time before.

Yet few industry standards are clearly understood, consistently applied, and sufficiently comprehensive to cover all the ground.  One primary example lies in the gap between compliance requirements for dietary ingredients (under food GMP) and dietary supplements, whose GMP framework is derived from that for pharmaceuticals. The underlying litmus test for the level of safety demanded for supplements and foods are different – that of ‘non-adulteration’ versus ‘safe for human consumption’.  Maybe due to the differences, supplement GMP audit programs often tend to overlook the food GMP that governs ingredients. So it is not uncommon for a manufacturer and a supplier to speak completely different quality languages. Audits for supplement GMP are frequently unable to determine to a reasonable degree of certainty whether a particular ingredient, based on its COA, should be expected to meet supplement requirements once it is placed inside a capsule or tablet.

As could be expected, an unintended consequence of this gap is the common practice of a raw material certificate of analysis being simply duplicated as the manufacturer’s raw material specification.  In this scenario, an ingredient specification has been developed according to food requirements, and often without any further analysis or verification, is assumed to meet the requirements of the finished supplement. The end result is a supplement that is essentially of no better quality than the “food-grade” ingredients put into it.

For botanicals and animal-derived raw materials, there is the added dimension of cultivation and processing before they are made into usable ingredients. This is a complicated problem, particularly for a global supply chain of agricultural materials that may or may not pick up contaminants during farming, harvesting, processing, storage or transportation to the ingredient processing facility. These contaminants may not be necessarily listed on the specification or controlled by the food GMP, yet can cause the supplements to which they are added to be adulterated.

Then there are the dozens of standards written for agricultural products, many of which don’t (or can’t) apply to the small family farmer that are a predominant source of botanical raw materials. In addition to recent FSMA requirements for fresh produce (which don’t really apply to dried agricultural materials), we also have USDA Good Agricultural Practices (which are intended for large farms and seldom fully practiced in the U.S.);  NOP Organic (which requires no testing for contaminants like pesticides that may cause a product to be adulterated); independent farm standards  like Global G.A.P. (also intended for large, modernized industrial farms); and dozens of Good Agricultural and Collection Practices (GACP) for medicinal plants that have been independently written by various nations and trade groups.

There are those who say that the mess of standards, the dynamics of industry, and the law of entropy do not support the possibility of a clear and unified regulatory structure.  Yet there are many others who recognize the limitations, yet remain busy sewing the patches together into a quilt that is greater than the sum of its parts.

Fortunately, a number of initiatives are in process or recently completed that contribute to the integrity of our industry quilt, and have provided a lot of free information.  Just in the past couple years:

• The U.S. Pharmacopoeia and American Herbal Pharmacopoeia have developed a number of monographs and methods for testing dietary supplement ingredients.
• USP has also developed a Food Fraud Mitigation Database that lists adulterants common for food ingredients
• AOAC International has developed a number of analytical methods for dietary supplement ingredient potency and contaminants.
• The NIH Office of Dietary Supplements website has become a valuable source of information and resources.
• Trade groups like the American Herbal Products Association and American Botanical Council have made enormous efforts to educate and guide the industry on issues around botanical dietary ingredients and adulteration, including a recently updated draft GACP from AHPA, and the ABC-AHP-NCNPR Botanical Adulterants Program.
• The Supplement Online Wellness Library (or OWL) was established by the Council for Responsible Nutrition, to allow labels for supplement products on the U.S. market to be put into in one place.
• The Supplement Safety and Compliance Initiative (SSCI) was formed as a broad industry initiative, with wide support from the trade associations, to address some of the gaps for supplements that aren’t sufficiently covered under other standards.  SSCI is led by a number of experienced players in retail, manufacturing and supply, and includes a focus on identity, risk assessment and quality for raw materials.
• In response to consumer demand, a number of leading retailers, manufacturers and ingredient suppliers have invested significant resources into traceability and quality, and are now able to make meaningful claims to these effects that are not only important to consumers, but also serve as a reliable way to differentiate from the competition.

Today’s movement towards a greater level of education and transparency includes a firming of the gaps, especially where raw material traceability and quality are concerned. Successful companies across the entire supply chain are actively improving and adopting new standards as they come along, building a level of quality and integrity that provides lasting value to their business.  Those who are upping their game are piecing together a quilt of their own, leveraging their quality advantages into claims that deliver marketing value. On the other side, those who continue to rely on ignorance or a lack of regulatory clarity as reason to take no action are increasingly left behind.

In an industry where faceless online product marketers are more common than they should be, and where a list of the tens of thousands of products on the market is just getting kicked off, efforts to fill in the gaps of our patchwork are probably a good thing for everyone.

First published in Natural Products Insider

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.