Dietary supplement makers press FDA to broaden ingredients to peptides

The FDA opened a public meeting Friday to revisit how the agency defines which substances can count as dietary-supplement ingredients—an issue that supplement makers say has become harder to navigate as newer “wellness” products increasingly feature ingredients that are not widely present in food. The meeting centered on whether the agency’s longstanding criteria should be broadened to include substances that do not come from food, vitamins, herbs or other traditional ingredient categories.

Kyle Diamantas, the FDA’s top food official, opened the session by emphasizing an administration focus on reducing industry regulatory burdens. Diamantas told attendees that the “industry has grown tremendously over the last 30 years yet the regulatory framework has largely stayed the same,” and he underscored the administration’s commitment to “cutting red tape” to lower the industry’s costs.

The meeting was held at the request of the Natural Products Association, an industry group that has clashed with the FDA over certain newer supplement ingredients. The group asked for the meeting in a January letter, citing what it described as “the cost and uncertainty that arise when regulatory expectations are unclear,” according to the AP report.

Friday’s session came as the FDA’s supplement policy approach operates under a broader legal structure that treats supplements as a category of food rather than as drugs. Under FDA regulations, dietary supplements are generally defined so that most of their ingredients come from plants, herbs and other substances found in the American diet, a requirement that supplement makers say has become strained as new products move beyond those traditional sources.

The issue was highlighted by peptides and probiotics. Peptides are druglike chains of amino acids that have been widely promoted by celebrities and influencers, and some clinics sell them as injections or IV infusions, while some supplement makers have begun adding them to capsules, gummies and powders. FDA lawyers have said such products violate FDA rules, and the same is described in the AP report for certain types of probiotics—bacteria-containing products marketed to aid digestion and promote gut health—when they are not treated as qualifying dietary ingredients under the agency’s interpretation.

Robert Durkin, a former official in the FDA’s supplements program who now consults for companies, told meeting attendees that the “hope of the meeting is that FDA is willing to open up its interpretation of what constitutes a dietary ingredient to allow dietary substances that aren’t already in food.” Consumer advocates pushed back, warning that expanding which ingredients qualify would enlarge the market for supplements even as FDA has struggled to oversee what’s sold and what claims companies make.

Jensen Jose, senior regulatory counsel of the nonprofit Center for Science in the Public Interest, said in a presentation at Friday’s meeting that “FDA should focus on making the current market safer instead of allowing more chemicals and substances in supplements.” The AP report also described a context of rising political and industry support for supplement and peptide changes after Robert F. Kennedy Jr. became the nation’s top health official last year and vowed to “end the war at FDA” on dietary supplements and peptides, according to the report.

The AP report said Kennedy has declared himself “a big fan” of peptides and has said he personally used them to treat injuries in a podcast appearance with Joe Rogan. The report also said Kennedy vowed to loosen FDA limits on producing injectable peptides that are subject to federal safety restrictions, while noting that some of Kennedy’s supporters and allies promote peptide-related products through private businesses and online sales channels.

Mitch Zeller, who worked on supplement issues at the FDA during the 1990s, said the existing system left room for health claims without the type of rigorous review used for drugs. In the AP report, Zeller said, “It sanctioned unauthorized, implied health claims,” and he described how supplement advertising and labeling can be structured to avoid treatment claims, even when companies use messaging that suggests medical effects.

The AP report said supplement makers are legally responsible for ensuring products are safe and truthfully advertised and that the FDA does not review dietary supplements the way it approves drugs and other medical products after confirming safety and effectiveness. The report also noted that the agency does not even maintain a list of all supplements in circulation and that the 1994 law gave the FDA oversight while exempting supplement makers from nutrition labeling requirements, under which companies must scientifically support health claims.

With those constraints in place, Friday’s meeting is likely to shape how the FDA views the question of “what counts” as a dietary ingredient as companies pursue new ingredient categories. Industry executives, consumer advocates and academics were slated to be heard, with the discussion focused on whether the agency’s interpretation should move to include substances that are not already in food.