Trump administration advances plan for peptide drugs favored by RFK Jr.

Before joining HHS, Kennedy publicly declared that 'FDA's war' on peptides would soon end

U.S. health officials are progressing with a plan that permits specialty pharmacies to manufacture specific peptides, a category of largely unregulated injections that have gained popularity among supporters of Health Secretary Robert F. Kennedy Jr. and various wellness influencers.

Kennedy's Department of Health and Human Services recently submitted a peptides "interim access policy" for White House review, as indicated by a posting on a governmental website. This policy has been forwarded to the Office of Management and Budget, which evaluates federal regulations that may have significant economic implications.

Peptides serve as fundamental components of more intricate proteins, promoting the release of essential hormones that facilitate growth, metabolism, and healing within the body. Pharmaceutical companies have successfully brought several peptides to market as medications, including widely used treatments for diabetes and weight management.

However, the peptides currently under consideration have not undergone the extensive evaluation typically required. Despite this, they have resonated with individuals seeking enhanced physical appearance, improved energy levels, or muscle gain. It is important to note that these applications are not sanctioned by the Food and Drug Administration (FDA), and most available data regarding these peptides is derived from animal studies.

Prior to his appointment in the administration, Kennedy expressed confidence that the "FDA's war" on peptides and various wellness products would soon cease.

Upon assuming the role of health secretary, Kennedy asserted that U.S. compounding pharmacies should be permitted to sell peptides, citing an increasing trend where Americans are resorting to "gray market" peptides sourced from countries such as China, which are readily accessible for purchase on platforms like TikTok.

While the White House filing lacks detailed information about the proposed policy, two individuals familiar with the plan indicate it is designed to temporarily allow pharmacies to compound some of the most sought-after peptides, including BPC-157, a compound marketed for muscle growth and injury recovery.

This development further underscores the intentions of Kennedy and other officials within the Trump administration to facilitate access to unverified products that have gained traction within the Make America Healthy Again movement. Notably, some prominent figures associated with MAHA are involved in the promotion and sale of peptide injections and supplements.

The FDA had previously categorized BPC-157 and over a dozen additional injectable peptides as too risky to be compounded by pharmacies due to potential hazards such as contamination, allergic reactions, and tumor formation.

Earlier this year, Kennedy instructed the agency to reassess a limited selection of substances that have been widely endorsed by wellness advocates and fitness personalities.

In July, an advisory panel composed of external FDA experts recommended that the agency lift its restrictions on six out of seven peptides presented to them, a suggestion that directly contradicted the scientific assessments of the FDA's staff scientists, who maintained that adequate research on the safety and effectiveness of these peptides had not been conducted.

The proposed policy submitted to the White House effectively assures compounding pharmacies—specialized businesses that create customized medications not available from conventional pharmaceutical manufacturers—that they will not face enforcement actions for producing specific peptides, according to the insiders briefed on the plan. This tactic, referred to as enforcement discretion, grants the FDA the ability to selectively refrain from implementing certain regulations.

Formally including the peptides on the FDA's list of drugs deemed safe for compounding would necessitate a federal rulemaking process, which could span years and involve multiple public comment periods. It remains unclear whether the administration intends to pursue this lengthy process.

The proposal has garnered prompt acclaim online from some of Kennedy's supporters who market peptides.

"This is huge," remarked Brigham Buhler, an operator of a wellness clinic that distributes peptides through an online service. "This isn't about whether you're for or against peptides. It's about whether you're for or against MEDICAL FREEDOM."

The external panel convened in July was appointed by Kennedy's health department and consisted of several doctors, pharmacists, and consultants who specialize in the peptide industry.

The growing peptide market has attracted the attention of major telehealth providers such as Hims & Hers and Noom, both of which have recently announced plans to offer peptides to their clientele should federal regulations be relaxed. Industry analysts project that the peptide market could reach a valuation between $2 billion to $3 billion.

— Matthew Perrone

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