Dietary supplement makers are pushing the FDA to allow peptides and other new ingredients

Makers of dietary supplements are pushing the Food and Drug Administration to expand the types of ingredients they can put in their products, a change that could open the way for the marketing of peptides, probiotics and other cutting-edge health offerings.

The FDA held a public meeting Friday to discuss its long-standing standards for dietary supplements and whether they could be expanded to include items that don’t come from food, vitamins, herbs or other traditional ingredients. FDA officials will hear from industry executives, consumer advocates and academics.

It is the first such meeting since Robert F. Kennedy Jr. became the nation’s top health official last year. Kennedy has promised to “end the war on the FDA” over the nutritional supplements, peptides and other products popularized in his American Health Restoration movement.

Friday’s meeting came at the request of the Natural Products Association, an industry group that has clashed with the FDA over certain new supplement ingredients. “The cost and uncertainty that arise when regulatory expectations are unclear,” the group called for the meeting in a January letter.

The FDA’s top food official, Kyle Dimantas, opened the meeting by outlining the agency’s commitment to “cutting red tape” to reduce industry costs.

“The industry has grown tremendously over the past 30 years, but the regulatory framework has remained largely the same,” Diamantas told attendees.

Here’s what to know about the issue:

Many health products do not qualify as supplements

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

This requirement has become a challenge for the industry in recent years as new health products often contain ingredients that have never been used in food.

Peptides, for example, are drug-like chains of amino acids widely promoted by celebrities and influencers to build muscle and look younger, although there is little science to support their use.

Most specialty pharmacies and clinics sell them as injections or IV infusions, but some supplement manufacturers have also begun adding them to capsules, gums, and powders.

Technically, these products violate FDA regulations, according to FDA attorneys. The same goes for certain types of probiotics, products containing bacteria that aid digestion and promote gut health.

The companies argue that the FDA rule, as written, does not specify that all ingredients must come from food.

“The hope of the meeting is that the FDA wants to open up its interpretation of what constitutes a dietary ingredient to allow nutrients that are not already in the food,” said Robert Durkin, a former FDA supplement program official who now consults for companies.

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

“The FDA should focus on protecting the current market rather than allowing additional chemicals and substances,” said Jensen Joss, senior regulatory counsel for the nonprofit Center for Science in the Public Interest, in a presentation at Friday’s meeting.

Attachment makers see Kennedy as an ally

Kennedy recently declared himself a “big fan” of peptides, telling podcast host Joe Rogan that he personally used them to treat injuries. He also pledged to ease FDA restrictions on the production of injectable peptides, which are subject to federal safety restrictions.

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

Dr. Mark Hyman, another friend of Kennedy’s, sells dozens of nutritional supplements through his website, including some that claim to contain peptides.

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

Kelly Maines, who now serves as a senior adviser at the Department of Health and Human Services, has created an online platform that helps people spend tax-free health dollars on supplements and other health items.

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

Supplements are never subject to strict FDA oversight

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

With about 100,000 or more supplements on the market, manufacturers are legally responsible for making sure their products are safe and truthful as advertised, according to the FDA. Supplements cannot claim to treat specific diseases or medical conditions.

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

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

Some early organizers think this approach was a mistake.

“It’s approved unauthorized, valid health claims,” ​​said Mitch Zeller, who worked on supplement issues at the FDA during the 1990s. “There are all kinds of claims in supplement labeling or advertising that are carefully worded to avoid making drug or treatment claims.”

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