Peptide Power: Supplement Industry Challenges FDA for New Ingredient Approval

WASHINGTON — Producers of dietary supplements are advocating for the Food and Drug Administration to broaden the range of ingredients permissible in their products. This potential shift could pave the way for increased marketing of popular wellness items like peptides and probiotics.

On Friday, the FDA convened a public meeting to deliberate on its long-standing criteria for dietary supplements, contemplating whether these guidelines could be expanded to encompass non-traditional ingredients beyond food, vitamins, and herbs. The discussions involved contributions from industry leaders, consumer advocates, and academic experts.

This marks the first gathering of its kind since Robert F. Kennedy Jr. assumed the role of the nation’s chief health official last year. Kennedy has pledged to resolve what he describes as the FDA’s opposition to dietary supplements, peptides, and other products that align with his Make America Healthy Again initiative.

The Natural Products Association, an industry organization that has previously been at odds with the FDA over new supplement ingredients, prompted Friday’s meeting. In a letter sent in January, the group highlighted “the financial burden and uncertainty” caused by ambiguous regulatory expectations, prompting their request for dialogue.

Kyle Diamantas, the FDA’s leading food official, kicked off the meeting by emphasizing the administration’s dedication to “streamlining regulations” in order to reduce industry expenses.

“Over the past three decades, the industry has seen significant growth, yet the regulatory framework has largely remained unchanged,” Diamantas remarked to those in attendance.

Here’s what to know about the issue:

Many wellness products don’t qualify as supplements

Under FDA regulations, supplements are deemed to be a category of food, with most of their ingredients coming from plants, herbs and other substances found in the American diet.

That requirement has become a challenge for the industry in recent years as newer wellness products often feature substances that have never been used in food.

Peptides, for instance, are druglike chains of amino acids that have been widely promoted by celebrities and influencers as a way to build muscle and look younger, although there’s little science supporting their use.

Many specialty pharmacies and clinics sell them as injections or IV infusions, but some supplement makers have also begun adding them to capsules, gummies and powders.

Technically, those products violate FDA rules, according to FDA lawyers. The same goes for certain types of probiotics, bacteria-containing products that are pitched to aid digestion and promote gut health.

Companies argue that FDA law, as written, doesn’t specify that all ingredients must come from food.

“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,” said Robert Durkin, a former official in the FDA’s supplements program who now consults for companies.

But consumer advocates warn that allowing new ingredients would vastly expand the market for supplements, which the FDA has long struggled to oversee.

“FDA should focus on making the current market safer instead of allowing more chemicals and substances in supplements,” said Jensen Jose, senior regulatory counsel of the nonprofit Center for Science in the Public Interest, in a presentation at Friday’s meeting.

Supplement makers view Kennedy as an ally

Kennedy recently declared himself “a big fan” of peptides, telling podcast host Joe Rogan that he’s personally used them to treat injuries. He also vowed to loosen FDA limits on producing injectable peptides, which have been subject to federal safety restrictions.

Some of Kennedy’s allies and supporters are proponents of the chemicals, including Gary Brecka, a self-described “longevity expert,” who sells peptide injectables, patches and nasal sprays through his website.

Dr. Mark Hyman, another Kennedy friend, sells dozens of dietary supplements, including some claiming to contain peptides, through his website.

Two former health advisers from Kennedy’s presidential campaign also have ties to the industry.

Calley Means, now serving as a senior adviser in the Department of Health and Human Services, co-founded an online platform that helps people spend tax-free health dollars on supplements and other wellness goods.

Dr. Casey Means – his sister and President Donald Trump’s surgeon general nominee – made hundreds of thousands of dollars promoting supplements, probiotics and related products, according to financial disclosure forms.

Supplements have never been subject to strict FDA oversight

The FDA does not review dietary supplements the way it approves drugs and other medical products after confirming their safety and effectiveness. The agency does not even have a list of all the products in circulation.

With some 100,000 or more supplements on the market, manufacturers are legally responsible for making sure their products are safe and truthfully advertised, according to the FDA. Supplements can’t claim to treat specific diseases or medical conditions.

The 1994 law that gave the FDA oversight of the industry also exempted supplement makers from nutrition labeling requirements, under which companies must scientifically support health claims.

Instead, supplement makers can make more general claims, such as that their products maintain or support health and well-being.

Some former regulators think that approach was a mistake.

“It sanctioned unauthorized, implied health claims” said Mitch Zeller, who worked on supplement issues at the FDA during the 1990s. “There are all manner of claims being made on supplement labeling or in advertising that are carefully worded to avoid making a drug or treatment claim.”

Companies can also say their products improve the structure or function of certain body parts, such as strengthening bones. Products making general or specific claims must carry a disclaimer: “This statement has not been evaluated by the FDA.”