The Department of Health and Human Services has advanced a plan that would let specialty pharmacies produce certain peptide injections without immediate FDA enforcement. The proposal, described as an "interim access policy," was sent to the White House Office of Management and Budget for review, according to a government posting. Two people familiar with the plan said it is intended to allow temporary compounding of popular peptides such as BPC-157, which is promoted for muscle building and injury healing.
These peptides have not gone through rigorous FDA review, and most data on them come from animal studies. The FDA had previously placed BPC-157 and over a dozen other injectable peptides on a list of substances too risky for pharmacy compounding, citing contamination, allergic reactions, and tumor growth. Health Secretary Robert F. Kennedy Jr. had publicly vowed to end what he called the FDA's war on peptides, and earlier this year directed the agency to reconsider several widely promoted substances. In July, an external FDA advisory panel recommended dropping restrictions on six of seven peptides, contradicting FDA staff scientists who said safety and effectiveness were not established.
The approach is known as enforcement discretion, meaning the FDA would selectively decline to enforce its own regulations rather than go through formal rulemaking, which could take years. The White House filing does not include specifics, and it remains unclear whether the administration will still pursue a formal rulemaking process. The proposal drew quick praise from some Kennedy allies who sell peptides, and telehealth companies such as Hims & Hers and Noom have announced plans to offer peptides if federal access is eased. Wall Street analysts estimate the market could be worth $2 billion to $3 billion.
Both sources for this article are wire reports from the Associated Press and present identical information, with no differing accounts.