US health officials are moving ahead with a plan to let specialty pharmacies produce certain peptides, the largely unregulated injections popular with wellness influencers and with Health Secretary Robert F. Kennedy Jr. The Department of Health and Human Services has submitted an interim access policy to the White House Office of Management and Budget, which reviews rules with significant economic impact.
The peptides at issue have not passed FDA review. The agency previously placed BPC-157, promoted for muscle building and injury healing, and more than a dozen other injectable peptides on its list of substances too risky for pharmacy compounding, citing contamination, allergic reactions and tumour growth among the possible risks. In July, a panel of outside advisers selected by Kennedy’s department recommended dropping restrictions on six of the seven peptides put before it, against the stated conclusion of FDA staff scientists that none had been studied enough to establish safety and effectiveness.
The expected mechanism is enforcement discretion: an assurance that the FDA will not target pharmacies compounding the named peptides, rather than a formal listing that would require years of rulemaking. Telehealth companies including Hims & Hers and Noom have already announced plans to offer peptides if access eases, and Wall Street analysts estimate the market at 2 billion to 3 billion dollars. Whether the administration also pursues the formal rulemaking route is not yet clear.