The Regulatory Patchwork of Dietary Supplements

In the United States, dietary supplements and their ingredients are subject to a patchwork of regulations, industry guidance, voluntary certifications and audit programs. With some exceptions, few standards for dietary supplements have been developed with expert consensus and  broadly implemented by the dietary supplement industry.

FDA’s dietary supplement GMPs (good manufacturing practices) are part of the exception and have made today’s supplement products generally a higher level of quality than at any time before.

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Yet few industry standards are clearly understood, consistently applied and sufficiently comprehensive to cover all the ground.

One primary example is the gap between compliance requirements for dietary ingredients (under food GMPs) 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,” Respectively. Maybe due to the differences, supplement GMP audit programs can overlook the food GMPs that govern ingredients. It is not uncommon for a manufacturer and a supplier to speak completely different quality languages. Audits for supplement GMPs are frequently unable to determine to a reasonable degree of certainty whether a particular ingredient, based on its certificate of analysis (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 major gap is the common practice of a raw material CoA being duplicated as the manufacturer’s raw material specification.

In this scenario, an ingredient specification has been developed according to food requirements and, often without further analysis or verification, it is assumed to meet the requirements of the finished supplement. The result is a supplement that is essentially of no better quality than the “food-grade” ingredients put into it.

Especially for botanicals and animal-derived raw materials: cultivation, harvesting and processing before the final ‘transformation’ adds another dimension..

Confirming identity and purity is a complicated problem, particularly for a global supply chain of agricultural materials susceptible to contaminants during farming, harvesting, processing, storage or transportation to the ingredient processing facility.

In many poorer countries, the supply chain, and contaminants are not as well regulated as in advanced nations, and are freely shipped with no knowledge of their destination. Likewise, the final manufacturer or end user may have no information on the source of the material beyond the previous dock. In an uncomfortable way, the U.S., with its more lax regulations, often receives the materials rejected by Europe. Thus, potential contaminants may not be necessarily listed on the specification or controlled by the food GMPs, yet they can cause the products to which they are added to be adulterated.

Dozens of standards have been written for agricultural products, many of which don’t (or can’t) apply to the small family farmers who are a predominant source of botanical raw materials. In addition to recent requirements for fresh produce established by the Food Safety Modernization Act (FSMA), which don’t really apply to dried agricultural materials, we also have: USDA good agricultural practices (GAPs), which are intended for large farms and seldom fully practiced in the United States; certified organic, which requires no testing for contaminants like pesticides that may cause a product to be adulterated; independent farm standards like Global GAP, which arealso intended for large, modernized industrial farms; and, dozens of good agricultural and collection practices (GACPs) for medicinal plants that have been independently written by various nations and trade groups.

Some experts say the mess of standards, the dynamics of the industry and the law of entropy do not support the possibility of a clear and unified regulatory structure.

Others recognize the limitations, yet remain busy sewing the patches together into a quilt that is greater than the sum of its parts.

Fortunately,

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

•             The U.S. Pharmacopoeia (USP) and American Herbal Pharmacopoeia (AHP) developed monographs and methods for testing dietary supplement ingredients.

•             USP also developed a Food Fraud Mitigation Database that lists adulterants common for food ingredients.

•             AOAC International developed analytical methods for dietary supplement ingredient potency and contaminants.

•             The National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS) website became a valuable source of information and resources.

•             Trade groups such as the American Herbal Products Association (AHPA) and American Botanical Council (ABC) 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-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program.

•             The Supplement Online Wellness Library (OWL) was established by the Council for Responsible Nutrition (CRN), 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 trade associations, to address some of the gaps for supplements that aren’t sufficiently covered under other standards. SSCI is led by 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, leading retailers, manufacturers and ingredient suppliers 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 toward 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, 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 available on the market is just getting online, our combined efforts to fill in the gaps of the collective regulatory patchwork benefits everyone.

This article was previously published in Natural Products Insider, July 2017.