Makers of dietary supplements are pushing the FDA to expand the types of ingredients they can put in their products, a change that could open the door to more marketing of peptides, probiotics, and other trendy wellness offerings.
The FDA was holding a public meeting Friday to discuss its longstanding criteria for dietary supplements and whether they could be broadened to include substances that don't come from food, vitamins, herbs, or other traditional ingredients. FDA officials will hear from industry executives, consumer advocates, and academics.
It's the first such meeting since Robert F. Kennedy Jr. became the nation's top health official last year. Kennedy has vowed to "end the war at FDA" on dietary supplements, peptides, and other products that are popular within his Make America Healthy Again 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 group asked for the meeting in a January letter, citing "the cost and uncertainty that arise when regulatory expectations are unclear."
The FDA's top food official, Kyle Diamantas, opened the meeting by underscoring the administration's commitment to "cutting red tape" to lower the industry's costs.
"The industry has grown tremendously over the last 30 years yet the regulatory framework has largely stayed the same," Diamantas told attendees.
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 drug-like 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, PhD, a self-described "longevity expert," who sells peptide injectables, patches, and nasal sprays through his website.
Mark Hyman, MD, another Kennedy friend, sells dozens of dietary supplements, including some claiming to contain peptides, through his website.
Two former health advisors from Kennedy's presidential campaign also have ties to the industry.
Calley Means, now serving as a senior advisor 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.
Casey Means, MD -- 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."
https://www.medpagetoday.com/primarycare/alternativemedicine/120540
