US Health Officials Advance Plan for Peptide Drugs Favored by Wellness Advocates

U.S. health officials are moving forward with a policy that would permit specialty pharmacies to produce certain peptide injections, a class of largely unregulated substances that have gained popularity among followers of Health Secretary Robert F. Kennedy Jr. and other wellness influencers. The Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to a posting on a government website. The plan was sent to the Office of Management and Budget, which reviews federal rules and regulations with potential economic impact.

Peptides are foundational components of proteins that trigger hormones involved in growth, metabolism, and healing. Pharmaceutical companies have developed several peptides into approved medications for conditions such as diabetes and weight loss. However, the peptides at issue in this policy have not undergone the same rigorous vetting process. Despite this, they have become popular for purported benefits like muscle building, anti-aging, and energy enhancement, uses that are not approved by the Food and Drug Administration (FDA). Much of the available data on these specific peptides comes from animal studies.

Before joining the administration, Kennedy had stated that the FDA's stance against peptides and other wellness products would change. After becoming health secretary, he argued that U.S. compounding pharmacies should be allowed to sell peptides as Americans were increasingly turning to unregulated, "gray market" options sourced internationally. These products remain accessible through online platforms.

The White House filing does not specify the details of the new policy. However, individuals familiar with the plan indicated it aims to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157, which is promoted for muscle building and injury healing. These individuals spoke on condition of anonymity to discuss confidential government deliberations.

This development suggests that Kennedy and other administration officials are seeking to ease access to unproven products favored by the Make America Healthy Again (MAHA) movement, whose prominent figures often promote peptide injections and supplements.

Previously, the FDA had designated BPC-157 and over a dozen other injectable peptides as too risky for compounding by pharmacies due to potential risks like contamination, allergic reactions, and tumor growth. Earlier this year, Kennedy directed the agency to reconsider a select group of these substances that have been widely promoted by wellness influencers and fitness celebrities.

In July, a panel of external FDA advisers recommended that the agency remove restrictions on six of the seven peptides presented to them. This recommendation contrasted with the FDA staff scientists' conclusion that none of the peptides had been sufficiently studied to confirm their safety and effectiveness. The new policy sent to the White House would signal to compounding pharmacies that they would not face enforcement action for producing certain peptides. This approach, known as enforcement discretion, allows the FDA to choose not to enforce certain regulations. Formally adding these peptides to the FDA's list of safe compounds would require a lengthy federal rulemaking process.

Supporters of Kennedy's stance praised the proposal online. Brigham Buhler, who operates a wellness clinic selling peptides, stated on X that the move is about "MEDICAL FREEDOM." The panel of outside experts that reviewed the peptides in July was selected by Kennedy's health department and included several doctors, pharmacists, and consultants involved in the peptide field.

The market for peptides has attracted the attention of major telehealth providers, such as Hims & Hers and Noom, which have announced plans to offer peptides if federal access is eased. Wall Street analysts estimate the market's potential value at $2 billion to $3 billion.