U.S. health officials are pursuing a plan to permit specialty pharmacies to manufacture specific peptides, a category of largely unregulated injectable substances that have gained popularity within wellness circles and among followers of Health Secretary Robert F. Kennedy Jr. The Department of Health and Human Services submitted an “interim access policy” regarding peptides to the White House for review, according to a government website posting. The proposal would allow compounding pharmacies to temporarily produce some of the most widely promoted peptides, including BPC-157, which is marketed to support muscle development and injury recovery.
Peptides serve as building blocks for proteins and trigger hormones necessary for growth, metabolism and healing. While pharmaceutical companies have brought several peptide-based medications to market, including treatments for diabetes and weight loss, the peptides in question have not undergone the FDA’s standard vetting process. These substances have become increasingly popular among people seeking to gain muscle, improve appearance or increase energy levels, though such uses lack FDA approval. Kennedy previously stated that the FDA’s regulatory stance on peptides would change under the new administration, and after taking office, he argued that American compounding pharmacies should be permitted to sell peptides because consumers were increasingly obtaining “gray market” alternatives from China and other countries available through online platforms.
The FDA had previously classified BPC-157 and more than a dozen other injectable peptides as too risky for pharmacy compounding, citing potential dangers including contamination, allergic reactions and tumor growth. However, Kennedy directed the agency earlier this year to reconsider a short list of chemicals promoted by wellness influencers and fitness celebrities. In July, a panel of external FDA advisers recommended that the agency remove restrictions on six of seven peptides reviewed, despite FDA staff scientists concluding that the peptides had not been adequately studied to establish safety and effectiveness.
The new policy would employ “enforcement discretion,” permitting the FDA to selectively refrain from enforcing certain regulations against compounding pharmacies producing specific peptides, rather than formally adding them to the FDA’s list of approved compounding drugs. The formal rulemaking process could require years and multiple rounds of public comment. The proposal has drawn support from peptide sellers online, while major telehealth companies including Hims & Hers and Noom have announced plans to offer peptides pending regulatory changes. Wall Street analysts estimate the peptide market could reach $2 billion to $3 billion.
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