Debate over the appropriate testing methodology of herbal extracts continues to rage on within the industry. The trade associations appear to be fractured on the issue and the industry simply appears to be confused as to the appropriate course of action. Unfortunately, this debate completely misses the point. 

Rather, the larger issue at hand is about ensuring the integrity of the supply chain. We as an industry continue to sweep under the rug critical issues related to the supply chain that cannot be solved by debating the appropriate test methods until we all simply want to scream. Dietary ingredient supply chains contain far too many low quality ingredients that may be adulterated with any number of contaminants, including active pharmaceutical ingredients.

While testing is necessary to help ensure the quality of finished products as well as the individual dietary ingredients, proper manufacturing controls at the ingredient level is as important as testing itself.

Standards for Suppliers
In this regard, efforts to ensure the quality of dietary supplements in the food supply can only be fully realized by requiring manufacturers and suppliers (collectively, “dietary ingredient suppliers”) of dietary ingredients—the building blocks of any finished dietary supplement—to 1) adhere to the Part 111 standards of quality that help ensure authentic and safe finished dietary supplement products and 2) ensure the products they produce are not adulterated in violation of Section 402 of the Federal Food, Drug, and Cosmetic Act (FDCA) and meet the requirements of Section 403 of the FDCA. 

Including dietary ingredient suppliers within Part 111 is essential from a product quality and production standpoint. In many instances, dietary ingredient suppliers are best equipped with the skill and expertise to evaluate the quality and identity of a raw material. For example, certain botanicals must be harvested from a certain geographic region or at a certain time of year to ensure their optimal potency, or certain parts of the plant must be used to ensure effectiveness. The dietary ingredient supplier in the best position to determine whether these factors have been met.

Indeed, the finished supplement manufacturer likely cannot control for these important botanical attributes via identity or in-process testing. While much has been made over the use of DNA testing to help establish the identity of botanicals, such testing does not provide any information as to the quality of the botanical used to manufacture the dietary ingredient. 

As emphasized by industry comments submitted in response to the 2003 Proposed Rule, “the difficulty to test in-process, or in the finished product, some botanical and other dietary ingredients, makes it necessary to include raw ingredient manufacturers in the rule to ensure consistent high quality from the beginning” (National Nutritional Foods Association, Comments re: Dietary Supplement CGMP Proposed Rule, Docket No. 96N-0416).

Exempting dietary ingredient suppliers has and will continue to undermine FDA goals of establishing a reliable system of production and process controls that is performed by those persons best equipped to assess the quality of dietary ingredients.

Indeed, under the existing regulations, dietary ingredient suppliers have no regulatory obligation to manufacture or hold dietary ingredients in accordance with the specific production and process controls that are necessary to ensure finished product quality. Absent contractual obligations, dietary supplement manufacturers and consumers have no recourse against such suppliers that fail to manufacture quality products. 

Such a regulatory framework falls short of Congress’s intent that FDA establish regulations to oversee the quality of dietary supplements. Moreover, this omission of dietary ingredient suppliers from the cGMP regulations has permitted the introduction of dietary ingredients with questionable quality at significantly lower price points than dietary ingredients that are manufactured pursuant to GMPs. 

Legitimate suppliers are under pressure to compete with these low-cost, low quality options that have flooded the marketplace. These dietary ingredient suppliers that offer products of questionable quality threaten the very existence of the legitimate supply chain. Yet, FDA and the industry have permitted this to continue at the expense of the reputation of ethical dietary ingredient suppliers and finished product companies. 

Petition for Revision
To be clear, FDA has the statutory authority pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) to require dietary ingredient suppliers to comply with Part 111, and only by so doing can FDA fulfill its public health mandate and help restore consumer confidence in the quality of dietary supplements.

As discussed in the recent citizens petition by the Organic and Natural Health Association (ONHA), neither the existing regulations governing dietary ingredients and finished dietary supplements nor the proposed rules under the Food Safety Modernization Act (FSMA) adequately address the quality manufacturing of dietary ingredients. Moreover, neither justifies the exclusion of dietary ingredient suppliers from the responsibility to manufacture products in accordance with quality standards. 

The interesting part is that the reputable dietary ingredient suppliers welcome Part 111 and are already complying with it. Yet, we force these suppliers to compete against others that offer low quality alternatives, counterfeited ingredients, or a combination thereof. Unfortunately, the reputable suppliers are hammered in the marketplace by these low-cost suppliers, and the losers in this scenario are the consumers that we serve, as well as the reputation of the industry. 

People who know me know I am not a fan of government regulation and I am willing to challenge orthodoxy. However, because DSHEA created a system where we have very little barrier of entry into the marketplace, it is time to impose a barrier of entry that makes sense and is designed to safeguard the integrity of the industry and its supply chain.

While placing the dietary ingredient suppliers under Part 111 is not a panacea, it does send the right message to regulators and the public that we are serious about quality and ensuring safe and effective products. As many have heard me say in the past, it’s time to put on our big pants, stop whining and trying to change the subject, and take ownership of the real issue, which is not testing, but the integrity of the supply chain. Until we do, we will continue to be perceived as the Wild Wild West, which may eventually lead to amending DSHEA in a manner that is neither helpful to the industry nor the consumers that want access to dietary supplements.

I hope everyone will write FDA and support the Organic and Natural Health Association’s citizen’s petition. Together, we can make a difference.

---

Todd Harrison, Michelle Jackson & Kristen Klesh
Venable

Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.

Michelle Jackson’s practice is focused on regulatory counseling concerning the development, formulation, manufacture, distribution, and promotion of foods, dietary supplements, drugs, medical devices, and cosmetics.

Kristen Klesh is an associate in Venable’s Regulatory Practice, where she focuses on advising clients on a range of FDA and FTC regulatory matters, including promotional and marketing practices, manufacturing compliance, and regulation of clinical research.