The dietary supplement industry is advocating for the Food and Drug Administration (FDA) to broaden its regulations regarding the types of ingredients that can be included in these products. This shift could facilitate the increased marketing of popular wellness options like peptides and probiotics. On Friday, the FDA hosted a public meeting addressing its existing criteria for dietary supplements and the potential to include substances not derived from traditional food sources, vitamins, or herbs. Industry stakeholders, consumer advocates, and academics engaged in discussions regarding this important topic. This meeting marks the first gathering since Robert F. Kennedy Jr. took on the role of the nation’s health official last year, with a commitment to reform the FDA’s stance on dietary supplements and enhance public health initiatives.
The event was organized at the request of the Natural Products Association, an industry group that has expressed concerns over the FDA’s stance on new supplement ingredients. Their January letter highlighted the challenges and uncertainties arising from unclear regulatory expectations. Kyle Diamantas, the FDA’s leading food official, opened the forum by emphasizing the agency’s dedication to “cutting red tape” to alleviate costs for the industry. “The industry has expanded significantly over the past 30 years, yet the regulatory framework has largely remained unchanged,” Diamantas explained to attendees.
Many Wellness Products Don’t Qualify as Supplements
Under current FDA regulations, dietary supplements are categorized as food, with most ingredients sourced from plants, herbs, and other naturally occurring substances found in the American diet. This regulation presents challenges for the industry as newer wellness products feature ingredients that have never been used in food.
Peptides serve as an example—they are amino acid chains that have been heavily promoted by celebrities and influencers as remedies for muscle building and anti-aging, despite limited scientific backing. While many specialty pharmacies and clinics offer peptides as injections or IV infusions, some supplement manufacturers are starting to include them in capsules, gummies, and powders.
According to FDA legal experts, these products technically violate existing FDA regulations, as do certain probiotics that are marketed as aiding digestion and promoting gut health. Industry representatives argue that the current FDA laws do not require all ingredients to be sourced from food. “We hope this meeting encourages the FDA to expand its interpretation of dietary ingredients to include substances not currently classified as food,” noted Robert Durkin, a former FDA official turned industry consultant.
However, consumer advocates caution that opening the door for new ingredients may significantly enlarge the supplement market, which has already proven difficult for the FDA to supervise. Jensen Jose, senior regulatory counsel with the nonprofit Center for Science in the Public Interest, stated during the meeting, “The FDA should prioritize making the current market safer rather than introducing more novel substances into supplements.”
Supplement Makers View Kennedy as an Ally
Kennedy has expressed strong support for peptides, sharing on a podcast with Joe Rogan that he has personally used them for injury treatment. He has also committed to loosening the FDA’s restrictions on injectable peptides, which have historically faced stringent federal safety regulations. Prominent supporters of Kennedy, such as longevity expert Gary Brecka, who sells peptide injectables online, also align with this advocacy.
Notably, Dr. Mark Hyman, another ally of Kennedy’s, markets numerous dietary supplements, including those containing peptides, through his own website. Additionally, two former health advisers from Kennedy’s presidential campaign maintain connections to the supplement industry. Calley Means, currently a senior adviser at the Department of Health and Human Services, co-founded an online platform that enables users to purchase supplements and wellness products with tax-free health dollars. Dr. Casey Means, Kennedy’s sister and President Donald Trump’s nominee for surgeon general, has reportedly earned substantial income promoting various supplements and probiotics, based on financial disclosures.
Supplements Have Never Been Subject to Strict FDA Oversight
Unlike pharmaceuticals, the FDA does not evaluate dietary supplements with the same rigorous standards required for drug approval, which includes establishing safety and effectiveness. Furthermore, the FDA lacks a comprehensive list of all dietary supplements currently available in the market. With over 100,000 supplements in circulation, manufacturers are responsible for ensuring their products are safe and correctly advertised, as mandated by FDA regulations. Notably, supplements cannot claim to treat specific medical conditions.
A 1994 law that granted the FDA regulatory oversight of dietary supplements also exempts manufacturers from nutrition labeling requirements, meaning companies do not have to substantiate health claims scientifically. Instead, supplement manufacturers may make broad statements that their products promote health and well-being without rigorous evidence.
Some former regulators believe this approach has been detrimental. Mitch Zeller, a former FDA executive involved in supplement regulation during the 1990s, remarked, “This framework has allowed for unauthorized claims that imply health benefits.” He noted the various claims made in supplement labeling and promotions are often designed to skirt direct medical claims. Additionally, companies are permitted to assert that their products bolster the structure or function of body parts—like strengthening bones—but must include disclaimers such as, “This statement has not been evaluated by the FDA.”
As discussions continue regarding the future of dietary supplements, the potential for new ingredients raises critical questions about safety, efficacy, and regulation. The industry’s push for expanded ingredient inclusion could reshape the landscape of dietary supplements, balancing innovation with the responsibility to protect public health.
