Dietary Supplement Makers Urge FDA to Approve Peptides and New Ingredients

WASHINGTON — The dietary supplement industry is advocating for the Food and Drug Administration (FDA) to broaden the types of ingredients permitted in their products. This change could pave the way for increased marketing of popular wellness trends such as peptides, probiotics, and more.

On Friday, the FDA convened a public meeting to revisit its long-established criteria for dietary supplements. Officials are considering whether to include ingredients that do not originate from traditional sources like food, vitamins, or herbs. The meeting provided a platform for industry leaders, consumer advocates, and academics to share their viewpoints.

This gathering marks the first since Robert F. Kennedy Jr. took office as the nation’s top health official last year. Kennedy has committed to “ending the war at the FDA” regarding dietary supplements and associated products popular within his Make America Healthy Again initiative.

The meeting was requested by the Natural Products Association, an industry group that has had disputes with the FDA over new supplement ingredients. They voiced their concerns in a January letter, emphasizing “the cost and uncertainty stemming from unclear regulatory expectations.”

Kyle Diamantas, the FDA’s top food official, initiated the meeting by reaffirming the administration’s pledge to “cut red tape” and reduce costs for the industry.

“The industry has experienced tremendous growth over the past 30 years; however, the regulatory framework has largely remained unchanged,” Diamantas remarked to those present.

Here’s what you need to know about the ongoing discussion:

Many Wellness Products Do Not Meet Supplement Criteria

According to FDA regulations, dietary supplements fall under the umbrella of food, predominantly made from natural sources such as plants and herbs found in typical American diets.

This requirement has become increasingly problematic as new wellness products frequently include ingredients not previously used in food.

For example, peptides—chains of amino acids promoted by celebrities and influencers for their muscle-building and anti-aging properties—lack substantial scientific backing. These compounds are often sold as injections or IV infusions by specialized pharmacies and clinics, but some supplement producers have started incorporating them into capsules, gummies, and powders.

According to FDA attorneys, these products violate existing regulations. This also applies to certain types of probiotics, which are marketed to enhance digestion and overall gut health.

Industry representatives argue that current FDA regulations do not explicitly mandate that all ingredients must originate from food sources.

“The goal of the meeting is to explore whether the FDA is open to revising its definition of what constitutes a dietary ingredient to include substances not typically found in food,” stated Robert Durkin, a former FDA supplements program official now serving as a consultant.

However, consumer advocates express concerns that permitting new ingredients could dramatically expand the supplement market, complicating regulatory oversight for the FDA.

“The FDA should prioritize enhancing the safety of the existing market instead of permitting more chemicals and substances in supplements,” remarked Jensen Jose, senior regulatory counsel for the Center for Science in the Public Interest, during his presentation at Friday’s meeting.

Supplement Producers See Kennedy as an Ally

Kennedy recently expressed his support for peptides, sharing with podcast host Joe Rogan that he has used them to address injuries. He has committed to relaxing FDA regulations surrounding the production of injectable peptides, which are currently subject to federal safety restrictions.

Some of Kennedy’s supporters are advocates for these chemicals, including Gary Brecka, a self-styled “longevity expert” who markets peptide injectables, patches, and nasal sprays through his platform.

Dr. Mark Hyman, a close acquaintance of Kennedy’s, also sells a variety of dietary supplements, including those purported to contain peptides, through his website.

Furthermore, two former health advisors from Kennedy’s presidential campaign have connections to the industry.

Calley Means, now a senior adviser in the Department of Health and Human Services, co-founded an online platform that enables consumers to utilize tax-free health dollars for purchasing supplements and other wellness products.

Dr. Casey Means—Kennedy’s sister and a nominee for President Donald Trump’s surgeon general—has reportedly earned hundreds of thousands promoting supplements, probiotics, and related products, according to financial disclosures.

Lack of Stringent Oversight for Supplements

Unlike drugs and other medical products, the FDA does not review dietary supplements for safety and effectiveness prior to their release. The agency also does not maintain a comprehensive list of all dietary supplements currently available on the market.

With an estimated 100,000 or more supplements available, manufacturers are legally tasked with ensuring the safety and truthful marketing of their products. Supplements are prohibited from claiming to treat specific illnesses or medical conditions.

The 1994 law that granted the FDA oversight of the supplement market also exempted manufacturers from nutrition labeling requirements, which necessitate scientific backing for health claims.

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“Instead, supplement manufacturers may make more generalized claims, asserting that their products support overall health and well-being.

Some former regulators have indicated that this approach was flawed.

Companies are also at liberty to claim that their products enhance the structure or function of specific body parts, such as promoting bone strength. However, products making either general or specific health claims must include a disclaimer stating: “This statement has not been evaluated by the FDA.”