HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has sparked concern among former agency officials and public health experts.
HHS secretary Robert F. Kennedy Jr. has criticized FDA’s earlier action as “illegal,” arguing the agency overstepped its authority by evaluating the effectiveness of the substances rather than focusing solely on safety, according to ProPublica. Speaking on The Joe Rogan Experience, Kennedy recently said regulators lacked sufficient evidence of harm to justify restricting the peptides.
However, several former FDA officials dispute that claim, saying the agency’s decision was grounded in documented safety risks and consistent with longstanding regulatory standards requiring evaluation of both safety and efficacy. Among them, former acting FDA Commissioner Janet Woodcock warned that reversing the policy could undermine decades of drug oversight, ProPublica reports. “It would be a disruption of the societal pact we have had since 1962 that drugs will be studied to see if they work before they are marketed in the U.S.,” Woodcock said.
Peptides — short chains of amino acids designed to influence biological processes — have surged in popularity in recent years, particularly among fitness and longevity communities. Despite the growing demand, experts say there has been little new scientific evidence supporting the safety or effectiveness of many of the substances restricted by the agency in 2023.
The agency placed 19 peptides into a category of substances considered too risky for compounding, citing concerns such as immune reactions, contamination risks during manufacturing, and limited clinical data. Some studies involving specific peptides have reported adverse events, including serious complications and deaths, though causation was not always clear. At the same time, demand has fueled a largely unregulated gray market. Wellness clinics, telehealth providers and online vendors often sell so-called “research-grade” peptides labeled as not intended for human use, raising additional safety concerns.
The issue centers on how FDA regulates substances used by compounding pharmacies, which create customized medications for patients. Under federal law, compounders may only use ingredients that are part of approved drugs, meet specific quality standards, or appear on an FDA-approved list known as the “bulks list.” The peptides in question do not meet those criteria, and the FDA’s 2023 action reinforced that they should not be used, ProPublica notes.
Industry groups, including the Alliance for Pharmacy Compounding, argue that allowing regulated compounders to handle peptides would be safer than leaving consumers to obtain them through unregulated channels. The group acknowledges limited clinical evidence but points to patient testimonials and widespread use as justification for broader access.
Critics counter that such arguments sidestep the core issue of safety and effectiveness. “They’re totally unapproved drugs,” one former FDA official said. “Would you let a pharmaceutical company do this? No.”
Kennedy has not yet outlined a detailed plan, but suggested the administration could take steps to make certain peptides more accessible. Regulatory options include reclassifying the substances, loosening enforcement, or using executive authority to override prior FDA determinations.
Former officials warn that such actions could create the impression that the substances are safe without sufficient evidence. Woodcock noted that the HHS secretary has broad authority, but cautioned that similar past interventions have faced legal challenges, according to ProPublica.
The debate comes as peptide-based therapies, including widely used GLP-1 drugs for weight loss and diabetes, gain mainstream acceptance. While those medications are FDA-approved and supported by clinical data, experts stress that most peptides circulating in the gray market lack comparable evidence.