HHS orders FDA to allow sales of six unproven wellness peptides

The Department of Health and Human Services issued a draft policy on Wednesday that instructs the Food and Drug Administration to stop enforcing rules against specialty pharmacies selling six specific wellness peptides. This move allows the sale of injectable compounds such as BPC-157, TB-500, and KPV, which have not undergone the standard review process for safety and effectiveness. Health Secretary Robert F. Kennedy Jr. has publicly supported the use of these drugs for muscle repair and energy.

FDA scientific staff opposed the change with little input during its development, according to six people familiar with the deliberations. These staffers warned that the policy could undermine the agency's long-standing mission to keep unproven health products off the U.S. market. The individuals spoke to The Associated Press on the condition of anonymity to discuss confidential government decisions.

The policy directs the FDA not to take action against pharmacies that sell these chemicals, which are currently considered illegal drugs under federal regulations. Kennedy stated in the document that the change advances patient choice while protecting Americans from peptides sold online that are often made from unscreened ingredients. The government will accept public comments on the measure for two weeks before finalizing the rules.

Lee Rosebush of the American Academy of Peptide Medicine described the move as a huge step for medical freedom. The group represents people who prescribe or sell peptides but is not a traditional medical professional organization. Major telehealth providers, including Hims & Hers, have announced plans to offer wellness peptides once the government policy is updated. Wall Street analysts estimate the market for these products could exceed $2 billion.

Some peptides occur naturally in the body to trigger hormones for growth and healing, but the specific chemicals in the new policy have not been approved by the FDA. They are promoted for conditions including insomnia, anxiety, and migraines. Dr. Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, noted that the FDA has already approved rigorously tested drugs for those same conditions.

Lurie questioned the timing of the decision, which occurred days before the midterm election. He described the move as a signal to Kennedy’s Make America Healthy Again supporters in the hope that they would vote. A spokesperson for HHS said the agency is confronting the risks of black-market peptides by providing a more controlled alternative through licensed U.S. compounders.

The final policy is a step back from HHS' original plan to have the FDA draft an official regulation deeming the peptides safe for compounding. FDA officials warned that scientific staff had major safety concerns and would not support such a regulation. HHS instead opted for a directive to limit enforcement, while FDA staffers provided technical assistance to include guardrails. These require pharmacies to use ingredients from FDA-registered factories and to collect data on side effects.

Lurie pointed out that the FDA lacks the legal authority to enforce those specific pharmacy requirements. The Alliance for Pharmacy Compounding said it needs clarification on when the policy takes effect and how it will interact with state pharmacy boards. In 2023, the FDA added more than a dozen peptides to its list of substances that should not be compounded due to risks of allergic reactions, kidney damage, and tumor growth.