FDA Staff Oppose Plan to Let Unproven Peptides Reach Shelves

Consumers who buy injectable wellness peptides online may soon have another source for the products. A draft policy from the Department of Health and Human Services would instruct the Food and Drug Administration to stop acting against specialty pharmacies that sell certain unapproved compounds. The move would make substances like BPC-157 and TB-500 legally available through compounding pharmacies, a shift that has divided federal scientists and policy makers.

Six people familiar with the process said most scientific staff at the FDA opposed the plan. The guidance, which recently cleared White House review, would tell the agency not to enforce its rules against pharmacies selling these peptides. Without the new policy, these substances are technically illegal drugs because they have not passed the FDA’s standard review for safety and effectiveness. The staffers reported they had limited input in drafting the final document.

The substances at issue are popular in the wellness industry. Some occur naturally in the body to trigger hormones for growth and healing. Drug companies have turned similar molecules into approved treatments for diabetes and weight loss. However, the specific peptides covered by this policy have not undergone that vetting process. International sports authorities currently list BPC-157 and TB-500 as doping substances. Health Secretary Robert F. Kennedy Jr. has called himself a big fan of peptides and recently described using BPC-157 to treat a muscle injury.

HHS officials initially planned a more aggressive approach. They wanted the FDA to write a formal regulation adding these peptides to a list of safe substances for compounding. FDA officials warned that agency scientists had major safety concerns and would not back a rule deeming the peptides safe. To avoid a direct clash with FDA staff, HHS shifted to the current approach of directing the FDA not to enforce its existing rules against compounding pharmacies.

FDA staffers provided technical help on the final plan, including specific safeguards. Pharmacies would be required to source ingredients from FDA-regulated factories and collect data on side effects. They must also verify the chemical identity of the peptides. The Alliance for Pharmacy Compounding, an industry group, recently met with White House officials about the proposal and supports those measures. Kennedy has argued that U.S. pharmacies must sell these products because Americans are currently turning to gray market imports from China.

The FDA has historically managed policies regarding compounding pharmacies. The agency added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded in 2023. Cited risks include allergic reactions, kidney damage, and tumor growth. In July, FDA staffers reiterated that more than half a dozen peptides brought forward for reconsideration remained unproven for safety and effectiveness.

Compounding pharmacies make customized medications and have grown into a multibillion-dollar industry. The sector drew national scrutiny after a deadly fungal meningitis outbreak in 2012 was traced to contaminated injections from a Massachusetts pharmacy. A spokesperson for the Department of Health and Human Services did not immediately respond to requests for comment on the draft guidance.