The news: Health and Human Services Secretary Robert F. Kennedy Jr. is bypassing the usual regulatory review process to let licensed compounding pharmacies produce six unapproved wellness peptides: BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. The peptides, which will require a prescription, are marketed for longevity, injury recovery, and other benefits.

Why it matters: The decision runs counter to warnings from FDA scientists citing limited evidence of the substances’ safety or effectiveness.

The FDA previously barred compounding pharmacies, which make customized medications, from producing these peptides over safety concerns. But Kennedy, a peptide advocate who has publicly discussed using them, sought to accelerate access. Compounded drugs aren’t FDA-approved, but pharmacies must generally meet federal requirements governing which ingredients they can use. Rather than formally adding the peptides to its list of permitted ingredients, Kennedy is allowing their production through “enforcement discretion” while the FDA reviews whether to authorize compounding them.

Physicians and scientists, including those at the FDA, warn that largely untested synthetic peptides could put patients at risk. Eighty-one percent of US physicians consider a clear FDA approval or review pathway essential or very important to help them guide patients using these substances, per a July Sermo survey.

HHS emphasized that the policy doesn’t constitute FDA approval or establish safety and efficacy. It also requires compounding pharmacies to meet certain testing and manufacturing standards and report serious adverse events, even without a confirmed link to the peptides—a requirement traditional compounders generally haven’t faced.

Implications for consumer health brands: Direct-to-consumer healthcare companies are poised to capitalize on peptides moving from the unregulated market into more legitimate sales channels. Consumer interest is strong, with 57% of clinicians in Sermo’s survey reporting at least occasional patient inquiries about peptides.

Hims & Hers, which owns a US-based peptide manufacturing facility, has wasted no time launching a waitlist for an upcoming peptides offering. Other telehealth brands are also moving quickly, with Time reporting that several were already marketing the six peptides for $199 to $249 per month shortly after the notice. Peptides could represent a roughly $2 billion telehealth market in 2027, per a July Leerink Partners estimate cited by Barron’s.

A sharp divide could emerge between credible online healthcare providers offering proper medical oversight and those capitalizing on demand to drive sales without adequate patient support. Similar concerns arose with GLP-1s, as some telehealth companies marketed and prescribed the drugs to patients who didn’t need them or failed to provide follow-up care. The risks will be even greater with wellness peptides, which lack the clinical evidence supporting GLP-1 drugs.

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