Dietary supplement makers seek FDA approval for peptides and other new ingredients

WASHINGTON (AP) – Dietary supplement makers are asking the Food and Drug Administration to expand the types of ingredients they can include in their products, potentially opening the door to further marketing of peptides, probiotics and other trendy wellness products.

The FDA held a public meeting Friday to discuss its long-standing standards for dietary supplements and whether they can be expanded to include substances not derived from foods, vitamins, herbs, and other traditional ingredients. FDA officials will hear from industry executives, consumer advocacy groups and academics.

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It was the first such meeting since Robert F. Kennedy Jr. became America’s top health official last year. President Kennedy vowed to “end the war at the FDA” over popular nutritional supplements, peptides and other products in the “Make America Healthy Back” movement.

Friday’s meeting was held at the request of the Natural Products Association, an industry group that has been in conflict with the FDA over certain new supplement ingredients. In a January letter, the group requested the meeting, citing “the costs and uncertainties that arise when regulatory expectations are unclear.”

Kyle Diamantas, the FDA’s top food official, opened the meeting by highlighting the government’s efforts to “cut out bureaucracy” to reduce costs in the food industry.

“Although the industry has grown significantly over the past 30 years, the regulatory framework has remained largely unchanged,” Diamantas told attendees.

Here’s what you need to know about this issue:

Many wellness products do not qualify as supplements

Under FDA regulations, supplements are considered a category of food, and most of their ingredients are derived 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 wellness products often contain substances never previously used in food.

For example, peptides are drug-like chains of amino acids that have been widely touted by celebrities and influencers as a way to build muscle and look younger, but there is little science to support their use.

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

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Technically speaking, these products violate FDA regulations, according to FDA lawyers. The same is true for certain types of probiotics, products containing bacteria, which are meant to aid digestion and promote gut health.

Companies argue that FDA law does not require all ingredients to be food-derived, as written.

“The hope of the meeting is that FDA will aggressively expand its interpretation of what a food ingredient is to allow the use of food substances that are not already in food,” said Robert Durkin, a former official in the FDA’s supplement program who now serves as a company advisor.

But consumer advocacy groups warn that allowing the new ingredients would greatly expand a supplement market that the FDA has long struggled to oversee.

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

Supplement makers see Kennedy as an ally

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

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

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

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

Carrie Means, currently a senior adviser at the Department of Health and Human Services, co-founded an online platform that helps people spend tax-free medical expenses on supplements and other health goods.

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

Supplements have never been subject to strict FDA oversight

The FDA does not review dietary supplements in the same way that it approves drugs or other medical products after determining their safety and effectiveness. The agency doesn’t even have a list of all the products it distributes.

According to the FDA, there are approximately 100,000 or more supplements on the market, and manufacturers have a legal responsibility to ensure their products are safe and truthfully advertised. Supplements cannot claim to treat any specific disease or medical condition.

The 1994 law that gave FDA oversight of the industry also exempted supplement manufacturers from nutrition labeling requirements that require them to scientifically back up their health claims.

Instead, supplement manufacturers 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.

“Unauthorized implied health claims have been authorized,” said Mitch Zeller, who worked on supplement issues at the FDA in the 1990s. “Supplement labels and advertising make all kinds of claims that are carefully worded to avoid making pharmaceutical or therapeutic claims.”

Companies can also say that their products improve the structure or function of specific parts of the body, such as strengthening bones. Products that make general or specific claims should include a disclaimer that says, “This statement has not been evaluated by the FDA.”