Manufacturers of dietary supplements are urging the Food and Drug Administration (FDA) to broaden the range of ingredients they can incorporate into their products. This change could lead to an increase in the marketing of popular items such as peptides and probiotics.
The FDA convened a public meeting on Friday to explore its existing criteria for dietary supplements and whether these guidelines can include substances that do not traditionally come from food, vitamins, or herbs. Officials from the FDA will hear from industry leaders, consumer advocates, and scholars.
This meeting marks the first since Robert F. Kennedy Jr. took office as the nation’s top health official last year. Kennedy has expressed a commitment to “end the war at the FDA” regarding dietary supplements, peptides, and other products favored by his Make America Healthy Again movement.
The discussion was initiated by the Natural Products Association, an industry organization that has often clashed with the FDA over newer supplement ingredients. They requested this meeting in January, highlighting the confusion and costs that arise from vague regulatory expectations.
Key Information about the Issue
Many wellness products currently fall outside the definition of supplements.
According to FDA regulations, supplements are categorized as food and their ingredients primarily originate from plant and herb-based sources commonly found in the American diet.
This requirement has posed challenges in recent years, as emerging wellness products frequently contain ingredients that have never been part of the traditional food supply.
For example, peptides are amino acid chains resembling drugs, heavily marketed by celebrities and influencers as tools for muscle building and youth enhancement, despite a lack of supporting scientific evidence.
Though certain specialty pharmacies and clinics offer these as injections or IV infusions, some supplement manufacturers have begun including them in capsules, gummies, and powders.
According to FDA lawyers, these products technically breach FDA regulations. The same applies to certain probiotics, which are marketed as enhancements for digestion and gut health.
Industry representatives argue that existing FDA law does not specify that all ingredients must be derived from food.
“The meeting aims to encourage the FDA to reconsider its interpretation of what qualifies as a dietary ingredient, allowing for substances not yet classified as food,” explained Robert Durkin, a former FDA supplements program official who now consults for companies.
If the agency refuses to redefine the term, legal action may be forthcoming, particularly following a 2024 Supreme Court ruling that limited federal regulators’ authority to implement laws and regulations at their discretion.
Supplement Makers See Kennedy as an Ally
Kennedy has publicly endorsed peptides, explaining to podcast host Joe Rogan that he personally utilizes them for injury treatment. He has also pledged to relax FDA restrictions on the production of injectable peptides, which have faced federal safety protocols.
Some of Kennedy’s associates back the use of such chemicals, including Gary Brecka, who calls himself a “longevity expert” and sells peptide injectables, patches, and nasal sprays on his website.
Dr. Mark Hyman, another supporter of Kennedy, markets numerous dietary supplements, including some that purportedly contain peptides, through his online platform.
Two former health advisors from Kennedy’s presidential campaign maintain connections to the supplement industry.
Calley Means, now a senior advisor in the Department of Health and Human Services, co-founded a platform enabling users to use tax-exempt health funds for supplements and wellness products.
Dr. Casey Means, Kennedy’s sister and the nomination for President Donald Trump’s surgeon general, has reportedly earned substantial amounts promoting supplements, probiotics, and related items.
Lack of Stringent FDA Oversight for Supplements
The FDA does not assess dietary supplements with the same rigor it applies to pharmaceuticals and other medical products, focusing instead on confirming safety and efficacy. The agency doesn’t even maintain a comprehensive list of all available products.
With around 100,000 supplements on the market, manufacturers bear legal responsibility for ensuring the safety and truthful advertising of their products. Supplements cannot claim to treat specific diseases or conditions.
A law enacted in 1994, granting the FDA oversight authority, also exempted supplement manufacturers from the nutritional labeling requirements that obligate companies to scientifically validate health claims.
Instead, supplement companies may assert broader health benefits, such as maintaining or supporting general well-being.
Some former regulators believe this approach was misguided.
“It legitimized unauthorized, implied health claims,” remarked Mitch Zeller, who handled supplement issues at the FDA during the 1990s. “Numerous claims are made on supplement labels or in marketing that are worded carefully to sidestep making drug or treatment assertions.”
Companies may also suggest their products enhance the structure or function of body parts, such as fortifying bones. All products stating either general or specific claims must carry the disclaimer: “This statement has not been evaluated by the FDA.”
___
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
___
Stay informed about the FDA’s activities by visiting https://apnews.com/hub/us-food-and-drug-administration.
