HHS Moves to Let Pharmacies Make Popular Peptides the FDA Had Deemed Too Risky

The Department of Health and Human Services has sent the White House a plan that would temporarily allow pharmacies to make some popular peptide injections that the Food and Drug Administration had placed off-limits, advancing a long-standing goal of Health Secretary Robert F. Kennedy Jr.

The “interim access policy” was posted Thursday on a government website and forwarded to the Office of Management and Budget, which reviews rules that could have a significant economic impact. The filing itself gave no details. Two people familiar with the plan told The Associated Press, on condition of anonymity, that it would let compounding pharmacies, which mix customized medications, temporarily produce some of the most popular peptides, including one called BPC-157. HHS did not immediately comment, the AP reported.

Rather than changing the rules, the policy would rely on enforcement discretion, essentially assuring pharmacies that the FDA will not act against them for making certain peptides. Formally adding the substances to the FDA’s list of ingredients that are safe for compounding would require rulemaking that could take years and include several rounds of public comment. It is unclear whether the administration intends to pursue that.

Peptides are short chains of amino acids, the building blocks of proteins. The ones at issue are largely unregulated injections promoted for building muscle, healing injuries, slowing aging and boosting energy. None are approved by the FDA for those uses, and most of the evidence behind them comes from animal studies. The agency previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances too risky to compound, citing the possibility of contamination, allergic reactions and tumor growth.

In July, an FDA advisory panel recommended lifting restrictions on six of the seven peptides it reviewed. That panel was selected by HHS and included doctors, pharmacists and consultants who work in the peptide field. The FDA’s own staff scientists disagreed, concluding that none of the peptides had been studied enough to show they are safe and effective.

Kennedy’s strongest argument is a practical one. Americans are already buying peptides from an unregulated gray market of products made in China and elsewhere, sold widely online, and he contends that letting licensed pharmacies make them would be safer than leaving people to those sources. Before joining the administration, he said the FDA’s campaign against peptides and other wellness products would soon end.

Critics counter that easing access to products with little human safety data, on the advice of a panel that included people with a stake in the market, puts commercial demand ahead of evidence. There is real money involved: telehealth companies Hims & Hers and Noom have said they plan to offer peptides if access is eased, and Wall Street analysts estimate the market could be worth $2 billion to $3 billion. Brigham Buhler, a wellness clinic operator who sells peptides, praised the move online as a matter of medical freedom.

The policy remains under review at the White House budget office.