Regulations, reorganization, and the road ahead for dietary supplements and natural products

As 2023 comes to a close, so too does another year of progress and innovation in the dietary supplement and natural product industries that the American Herbal Products Association (AHPA) proudly serves. The growth of newer product categories – such as fungi-based products and probiotic sodas – both captures and demonstrates the heightened level of consumer interest in supporting their personal health and wellness with dietary supplements and functional foods.

Even so, while product variety and availability today may look substantially different than it did in years past, a look back on AHPA’s efforts in 2023 to support the evolving industry through engagement with the U.S. Food and Drug Administration (FDA) evokes feelings of “the more things change, the more they stay the same.”

Modernizing labeling regulations​

AHPA has increasingly called for regulations governing dietary supplements and natural products to be modernized to better reflect the current market for these products. Throughout 2023, AHPA submitted comments to FDA draft guidances toward that effort, requesting revisions in support of responsible industry and well-informed consumers.

Early this year, AHPA submitted comments​ to FDA’s proposed rule updating the regulation governing “healthy” claims for food products, including dietary supplements. Under current regulations, use of the term “healthy” is considered an implied nutrient content claim in the labeling of food. Dietary supplements are intended to support a healthy diet and lifestyle, and, per current dietary guidelines, a healthy diet can include herbs and herbal products. Therefore, AHPA is advocating for dietary supplements, unsweetened coffees and teas, and herbs and spices to be able to bear “healthy” claims, among other requests made in our comments that support use of the term “healthy” in ways that will help consumers make beneficial diet choices.

In September, as a continuation of our work on labeling regulation, AHPA submitted comments​ to FDA’s draft guidance that recommended standards for the use of dietary guidance statements in food labeling. Dietary guidance statements are voluntary statements that “represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern.” Per the draft guidance, dietary guidance statements are not to be used on dietary supplements. However, similar to our position regarding “healthy” claims, AHPA contends that dietary supplements should be able to bear dietary guidance statements. Consumers should have every opportunity to learn about the role that these products play in a healthy and nutritious diet.

Though there have been no further regulatory developments on the use of “healthy” claims and dietary guidance statements, AHPA will continue to closely follow FDA's positions on nutrition labeling and fight for manufacturers and marketers of dietary supplements and natural products to be able to share truthful and not misleading information with the public. Meanwhile, in addition to commenting on draft guidances, AHPA has also taken other, proactive approaches to seek action from FDA on matters impacting the industry.

Calls for FDA action​

In April, an AHPA member informed us​ that Amazon had reportedly banned the sale of products containing Pinellia ternata​ based on a warning letter issued by FDA last year. In the letter, FDA alleged that a dietary supplement manufacturer's product was “adulterated” because the product label “lists Pinellia ternata​, a dietary ingredient which contains ephedrine alkaloids…” However, the regulation cited only deems a product “adulterated” if it actually contains ephedrine alkaloids. In fact, based on records provided by FDA in response to Freedom of Information Act (FOIA) requests from AHPA, it appears that FDA neither collected nor analyzed any samples of the Pinellia ternata​ product before alleging that it contained unlawful ephedrine alkaloids.

After review of these records and learning of Amazon’s ban, AHPA wrote to Cara Welch, Ph.D., Director of FDA’s Office of Dietary Supplement Programs (ODSP), with whom the association regularly communicates. In our letter, we requested that FDA issue a public correction regarding the adulteration allegation. Without such a specific statement, we are concerned Amazon and other retailers may continue to prohibit the sale of products labeled as containing Pinellia ternata​. In response, Dr. Welch did not directly acknowledge the agency’s erroneous adulteration allegation, stating only that she “would not expect the determination that a dietary supplement is adulterated under 21 CFR 119.1 to be based solely on labeling indicating a dietary supplement contains P. ternata​.”

Our work in support of botanicals continued when, in June, we published the highly anticipated third edition of Herbs of Commerce​​, which contains entries for over 2,800 separate plant species, over 1,000 botanical synonyms, over 300 Ayurvedic names, and over 700 pinyin​ names of herbs currently in trade. AHPA published the first edition of Herbs of Commerce​ in 1992 to provide self-governing guidance to reduce confusion associated with labeling botanical ingredients and established a single “standardized” common name for each listed herb. The publication took the force of federal law when it was incorporated by reference in 1997 as FDA completed rulemaking regarding the labeling of dietary supplements to implement the Dietary Supplement Health and Education Act (DSHEA).

In keeping with our calls to modernize regulations, AHPA submitted a Citizen Petition amendment​ requesting that FDA update the federal regulation referencing the first edition of Herbs of Commerce​ to reflect the newest, third edition. This request amended the Citizen Petition that AHPA submitted in 2017, in which we also sought to have FDA remove the reference to the first edition of Herbs of Commerce​ and replace it with the latest edition at the time. To date, FDA has not taken any action on our original Citizen Petition or recently submitted amendment.

AHPA’s continued engagement with FDA comes at a historic time for the agency, which has been criticized for what has appeared to be a relative inattention to food safety.

The future of FDA​

In June, following the 2022 infant formula shortage and subsequent evaluation by the Reagan-Udall Foundation, FDA shared a Proposed Human Foods Program Organization Chart as part of its proposal​ to create a unified Human Foods Program (HFP) and improve the agency’s regulation of food, including dietary supplements. The reorganization would move ODSP under a new Office of Food Chemical Safety, Dietary Supplements & Innovation as part of a unified HFP led by Jim Jones, Deputy Commissioner for Human Foods, who was appointed to the newly created position in September.

Upon learning of the proposed reorganization, AHPA expressed concerns​ about the potential impact on ODSP, which was elevated from its former status as a division in 2015. AHPA and responsible industry have made great efforts to increase ODSP’s budget and secure dedicated funding for the program, and we do not want to see these resources for dietary supplement activities diminished. In meetings with FDA officials, including Dr. Welch and most recently Jim Jones, AHPA has been assured ODSP will retain the same staffing, scope, and responsibilities under this reorganization and that FDA is committed to transparency. Further, FDA appears to be conveying an openness to both improving the flow of information from the agency and seeking input from industry.

For our part, AHPA welcomes transparency from FDA. It is worth nothing, however, that FDA has historically not been transparent with regard to dietary supplements, and some of its messaging about the category can be interpreted as imbalanced. Take, for example, the Dietary Supplement Ingredient Directory​, which was launched this year without input from industry and is arguably misnamed, and not well organized to clearly communicate its purpose. The directory is not a comprehensive list of dietary supplement ingredients at all. Rather, it is mainly a listing of agency actions involving these ingredients, which are not even exclusively found in dietary supplements, as well as ingredients found in drug products, including those that have been found by FDA to masquerade as dietary supplements.

If FDA is truly committed to transparency – that is, being open, accountable, and forthcoming with information and actions – this would represent a significant shift in how the agency deals with dietary supplements. AHPA would like to see FDA’s whole tone regarding dietary supplements change, aligning more with how the agency currently supports pharmaceuticals in areas such as funding, focus, and messaging to consumers.

Though the impact of FDA’s proposed reorganization remains to be seen, one thing is for certain: if a positive change in how dietary supplements and natural products are treated by FDA is coming, AHPA will be at the table to ensure the interests of our members are represented.