RFK, Jr., loosens restrictions for six popular peptides, bypassing the FDA

The Department of Health and Human Services (HHS) announced Wednesday a loosening of restrictions on six unproven peptides. These substances have long been touted by biohackers as a means to hack the bodies and brains for the better but which often have scant scientific evidence behind them. HHS chief Robert F. Kennedy, Jr. has voiced support for peptides in the past, such as the so-called "Wolverine Stack," a combination of two—BPC-157 and TB-500—that is meant to promote healing. Both of these are included in the list of peptides now available to dispense.

The new policy allows some licensed pharmacists to produce compounds made up of multiple peptides—provided those peptides are made by registered manufacturers. Users must also have a valid prescription to receive the compounds.

In a document outlining the new policy, the agency acknowledged that compounding drugs carries risks—they are not regulated in the same way as a name-brand or generic medication by the U.S. Food and Drug Association, leading to concerns over their safety and efficacy. But the agency said the level of public interest and available data had led it to expand access to some combinations of peptides, and that doing so would discourage the growing grey and black market for peptides.

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Peptides are small chains of amino acids, which are the building blocks of proteins. Humans produce a large number of peptides naturally, but taking them as supplements has become a major trend among health influencers, tech executives and the Make America Healthy Again movement. Depending on the peptide, they are marketed as helping with everything from extending lifespan to healing from injuries and workouts to improving one’s complexion. Perhaps the best-known peptide product on the market are glucagon-like peptide-1 (GLP-1) drugs, such as Ozempic and Mounjaro.

The peptides included under the new policy are: BPC-157 and TB-500; Epitalon, which is promoted as a sleep and longevity aid; KPV, which is used as an anti-inflammatory; MOTS-c, for obesity ​and osteoporosis; and Semax, a supplement for migraine and chronic pain.

These substances have not been approved for use as a medicine by the FDA. They are also rarely taken alone, and in some cases there is very little research as to what these so-called "stacks" might do to health. Despite that lack of evidence, several government agencies have begun analyzing how to make the substances more accessible, including by allowing some pharmacies to manufacture them.

HHS appeared to acknowledge the lack of data in its announcement, saying it may revisit the issue if safety or product quality issues arise as the compounded peptides become more available.

This is a breaking news story and may be updated.

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