One of the more successful activist campaigns in U.S. history was about keeping dietary supplements virtually unregulated. In the early 1990s, Americans besieged Capitol Hill with letters and phone calls demanding the government stay out of the public’s vitamin cabinet.
Following the outcry — which was largely orchestrated by the vitamin industry — Congress passed a law in 1994 that protected supplement makers from the burden pharmaceutical companies shoulder: having to prove through clinical trials that products were safe and effective before being sold to patients.
The supplement industry ballooned and is now valued at some $70 billion. Today it features some evidence-backed products, but also many dubious, sometimes dangerous, ones, including supposed metabolism, muscle and brain boosters. Americans often can’t know for sure what’s in these products or if they work as claimed. One study estimated that supplements caused thousands of emergency department visits each year; another found that they are a common cause of liver injury.
Now experimental peptides, unproven chemicals that are short chains of amino acids, could secure a similar shield by essentially bypassing full Food and Drug Administration review. It’s part of a broader push to increase the number of drugs and ingredients that don’t have to meet the strict evidence standards the F.D.A. usually requires before they are marketed as improving health.
There’s no question that the F.D.A. wasn’t designed for this wellness-crazed Ozempic era with flourishing telehealth, experimental peptides sold online from China, and social-media algorithms fueling it all. But the agency is also the only thing standing between consumers and a Wild West market for these drugs. There has to be a better way forward than dropping or circumventing the scientific standards meant to protect public health.
This week, an F.D.A. advisory committee voted in favor of regulatory changes that would increase access to six peptides — BPC-157, TB-500, KPV, MOTS-c, semax and epitalon — even though these drugs are not F.D.A.-approved. The decision came after Health Secretary Robert F. Kennedy Jr.’s office named eight new members to the committee, six of whom had ties to the peptide business. The committee’s decisions are nonbinding but if the F.D.A. adopts its advice, which it usually does, compounding pharmacies that mix drugs tailored for individual patients will be allowed to legally make and sell these peptides.
This meeting wasn’t just about peptides, however. It was a referendum on how to balance evolving consumer demand with scientific evidence. Americans want a health system that helps them lead a long, healthy life, and one that addresses their individual needs and concerns. They’re going outside the bounds of traditional health care in growing numbers.
The committee’s stance suggested Americans should get even more help doing just that. Historically, compounding pharmacies filled gaps in the drug ecosystem for individual patients. “Opening up the compounding pathway to more and more products just allows more and more products to go around the F.D.A.,” a drug regulatory expert at Harvard, Aaron Kesselheim, told me. “And we may never end up getting any of this useful information about how safe or effective the products are.”
Peptides are produced in the human body. Synthetic versions of them have long been used in medicine and can be genuinely revolutionary. Insulin and Ozempic are both F.D.A.-approved peptides and have decades of rigorous human clinical trials backing their safety and effectiveness.
For the batch of unapproved peptides the committee voted on, the clinical evidence runs thin to nonexistent. Booming on the gray and black markets, these drugs are often produced in China and marketed on websites that purport to sell them for the purpose of “research.” Social media influencers and even some clinicians promote their use for everything from weight loss to wrinkle reduction to longevity.
Ahead of the meeting, the F.D.A.’s own scientists advised against their broader use, because data from studies in humans are so lacking. The agency scientists also raised concerns that they are difficult to consistently manufacture, and at least one, epitalon, had properties that could theoretically promote cancer cell growth.
None of this deterred a majority of the committee members. They seemed to vote in favor of what Anant Vinjamoori, the chief medical officer of Hims, an online medication provider that plans to sell peptides, referred to as open-mindedness. In the public comment portion of the meeting, Dr. Vinjamoori spoke in support of BPC-157 — a drug for which there have been no completed large-scale randomized trials in humans, though patient anecdotes abound. He acknowledged the evidence for the peptide’s effectiveness was thin, but added don’t “read thin as nonexistent.”
Other speakers with a stake in the peptide market similarly made the case for medical freedom, claiming that they’ve seen remarkable turnarounds in the health of patients on these drugs. They pointed out that because the demand for peptides already exists, it’s better to have patients get them through trusted compounding pharmacies rather than on the gray or black markets. The arguments echoed those of Secretary Kennedy, who has acknowledged he’s “a big fan” of peptides. “My hope is that they’re going to get moved to a place where people have access from ethical suppliers,” he said on “The Joe Rogan Experience” podcast.
If the agency moves ahead, entrepreneurs will surely bank millions and some patients may find relief. But others may be harmed. Compounders are not even required to report adverse events for drugs like these to F.D.A., so the harms may never be accounted for.
To mitigate such risks, the National Institutes of Health could step in and study each drug. Or peptide companies could research them and then seek formal F.D.A. approval. The fact that they haven’t feels like an acknowledgment that they probably won’t work. The advisory members who voted to approve peptides cited, again and again, public demand, the way supplement proponents did in the 1990s. But where does this logic lead?
As Peter Lurie, president of the nonprofit Center for Science in the Public Interest and a former F.D.A. associate commissioner, told me, “This means that if you could generate enough demand, even illegally, F.D.A. would have to turn a blind eye. This is a profound challenge to the drug approval process itself.”
Julia Belluz is a contributing Opinion writer and an author of the book “Food Intelligence.”
Source photographs by Robert Brook/Science Phot Library and ElenVD/Getty Images.
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