Wire reporting: (AP, via Anchorage Daily News)

The U.S. Department of Health and Human Services posted a draft policy Wednesday that would tell regulators not to take enforcement action against compounding pharmacies that prepare six peptide drug substances that lack Food and Drug Administration approval^1,2,3.

The substances named in reporting and in the CBS account of the draft are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500^1,2,3. BBC said the draft originated in the health secretary's office rather than the FDA, an unusual path, and that a two-week public comment period is expected after official publication in the Federal Register later this week¹. Ars Technica said a Federal Register public-inspection notice listed publication for Oct. 30³.

Peptides are short chains of amino acids. Some approved peptide drugs, including insulin, have long been used as medicines¹. The six substances in the draft are not FDA-approved products^1,2. They have been marketed in wellness circles for unproven uses such as muscle building, injury recovery and energy, according to coverage of the policy^1,4.

HHS Secretary Robert F. Kennedy Jr. has described himself as a supporter of the drugs and previously said he wanted easier access after earlier restrictions on compounding^1,4. The Associated Press, carried by Anchorage Daily News and other outlets, reported that Kennedy has said he used BPC-157 for a muscle injury⁴.

The policy is enforcement discretion, not FDA approval of the peptides³. Ars Technica reported that in 2023 the FDA removed the six from the list of bulk substances compounding pharmacies could use, citing safety concerns³. BBC said an FDA advisory panel voted in July to loosen restrictions on the six, while FDA staff recommended against that step¹.

AP reporting, via Anchorage Daily News, said FDA scientific staff had little input on the HHS draft and opposed it, according to six people familiar with the process who spoke on condition of anonymity^4,9. Under ordinary FDA rules, AP said, the chemicals would be treated as unapproved drugs because they have not completed the agency's safety and effectiveness review⁴.

HHS, in accounts of the document, said the change would advance patient choice while steering people away from peptides sold online with ingredients of unknown origin^3,4. Ars Technica quoted the HHS text as saying the policy is meant to discourage research-use-only peptides from foreign manufacturers that the department says pose a safety risk³. Lee Rosebush of the American Academy of Peptide Medicine, which AP described as representing people who prescribe or sell peptides rather than a medical professional society, called the move a step for patient and provider medical freedom, AP reported⁴.

Health experts cited by BBC warned that the substances lack adequate human clinical trials and that long-term effects are unknown¹. Unregulated injectable peptides have been promoted online, including to teens, for unproven muscle-building claims, BBC reported¹. AP said the wellness peptide market has drawn telehealth companies and that analysts have estimated it could exceed $2 billion⁴.

What happens next is a short comment window and then a decision on whether HHS finalizes the interim policy^1,4. Whether FDA staff safety objections will change the final text is not established in public documents cited here.

Not medical advice.