Health and Human Services Secretary Robert F. Kennedy Jr. announced a policy change this week that will permit broader patient access to several unapproved peptide therapies, bypassing the usual Food and Drug Administration (FDA) drug approval process. The move has raised concerns among drug safety experts about patient risks and the erosion of regulatory safeguards.
Kennedy’s announcement, made public Wednesday, implements a form of “enforcement discretion” that allows certain compounding pharmacies to produce and distribute peptides without undergoing the standard FDA review, which typically assesses safety and effectiveness through rigorous clinical trials. This policy is a departure from established regulatory practices and was described by Kennedy as advancing "patient choice and freedom" while maintaining patient safety.
The unusual nature of the decision is underscored by the fact that it was reportedly made unilaterally by Kennedy, without participation from FDA scientists who had previously recommended against expanding access to these compounds. The agency’s advisory committee also expressed concerns during a July meeting about the lack of fundamental safety data, including potential immune system effects and cancer risk, and had advised against adding these peptides to the list of allowable compounded drugs.
The six peptides named in the new policy include epitalon, which is marketed as a longevity treatment, BPC-157—sometimes called the “wolverine” peptide for its purported muscle repair properties—KPV for skin conditions, MOTS-c linked to cellular metabolism, TB-500, originally developed for veterinary use, and semax, which is promoted for neurological and mental health conditions. None of these peptides have undergone the extensive clinical testing typical for FDA-approved medications, and their safety and efficacy remain unclear.
Compounding pharmacies that will prepare these peptides must be registered with the FDA and meet certain conditions, such as providing traceable ingredients and reporting adverse events. Nonetheless, these requirements mainly involve formalities like notifying the FDA of their location, rather than comprehensive safety oversight.
Critics warn that the policy could inadvertently encourage the use of unproven treatments and suggest that it sends a signal that the FDA tacitly endorses their use. John Hertig, chairman of the Collaborative for Evidence-Based Medicines, said the move effectively provides a “tacit recommendation” without proper scientific review, raising patient safety concerns.
Dr. Janet Woodcock, a former FDA official with four decades of experience, expressed that the new policy echoes earlier eras when folk remedies prevailed before modern drug regulations were established. She described it as undermining the principle of drug safety evaluations before public availability.
Supporters of the policy and the broader “medical freedom” movement, which Kennedy has publicly supported, argue it offers patients alternatives to unregulated products available on the black market and addresses patient demand for these therapies. The Department of Health and Human Services has emphasized that the policy does not amount to FDA approval and does not establish the peptides’ clinical safety or effectiveness.
The decision arrives amid rising interest in peptides driven by internet influencers and telehealth companies such as Hims & Hers and Noom, which have signaled interest in offering these treatments. However, the long-term impact of the policy on patient safety and the regulation of emerging therapies remains uncertain.