FDA Scientists Push Back on Plan to Ease Access to Unproven Peptides

Americans who use injectable wellness peptides will face fewer regulatory barriers starting now. The Department of Health and Human Services posted a new policy on Wednesday that instructs the Food and Drug Administration not to take action against specialty pharmacies selling these substances. The plan covers a small number of peptides, including BPC-157, TB-500, and KPV. These chemicals have not completed the FDA’s review process for safety and effectiveness.

Health Secretary Robert F. Kennedy Jr. supports the change. He described himself as a big fan of peptides and stated that he used BPC-157 to treat a muscle injury. Kennedy argues that US compounding pharmacies must be allowed to sell these products. He says Americans are currently turning to gray market products imported from China. Many users order vials online from Chinese chemical manufacturers. Sellers often label these items for research use only to avoid US regulations.

The path to this policy was not smooth. HHS initially planned for the FDA to write a formal regulation adding BPC-157 and other peptides to a list of substances considered safe for compounding. FDA officials responded that their scientists had major safety concerns. The agency did not support a regulation deeming the substances safe. HHS then shifted its approach. It moved to a policy that directs the FDA not to enforce its existing rules against pharmacies that compound these ingredients.

Six people familiar with the policy’s development told the Associated Press that most scientific staff at the FDA opposed the plan. They spoke on condition of anonymity because they were discussing confidential government deliberations. These staff members had limited input in drafting the document. The FDA staff ultimately provided technical help on the final version. This included safeguards requiring pharmacies to source peptide ingredients from FDA-registered factories.

The new policy also requires compounders to collect information on side effects for safety analysis. They must verify the chemical identity of the peptides. This approach avoids a direct clash with FDA staff. It only tells the agency not to enforce certain rules rather than changing the underlying standards.

Decisions on compounding have historically rested with the FDA. The agency’s focus on the issue grew after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts compounding pharmacy. Compounding is now a multibillion-dollar industry serving doctors, clinics, and hospitals. Former FDA officials said it is extremely rare for HHS to lead policy drafting on compounding. Federal law technically gives HHS authority over drug regulation, but it usually delegates this power to the FDA.

The FDA has previously warned about the risks of these substances. In 2023, the agency added more than a dozen peptides to its list of substances that should not be compounded. It cited risks of allergic reactions, kidney damage, and tumor growth. At a meeting in July, agency staff reiterated that more than half a dozen peptides up for reconsideration remained unproven for safety and effectiveness. The HHS policy takes effect immediately upon posting.