FDA sends White House a plan to ease access to unproven peptides
The Food and Drug Administration, under Health Secretary Robert F. Kennedy Jr., is moving forward with plans to ease access to unproven peptide drugs that are popular among members of Kennedy's Make America Healthy Again (MAHA) movement. Ars Technica notes that this comes despite FDA staff scientists finding that the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms.
The FDA submitted an "Interim Access Policy" on peptides for review by the White House, according to a filing notice posted on an Office of Management and Budget website. The posting does not provide information on the proposed policy. People familiar with the proposal told The Associated Press that it would give the FDA "enforcement discretion" on certain peptide drugs. In Ars Technica's description, that would allow the agency to choose not to enforce current restrictions on peptides, and would assure specialty pharmacies that are eager to start making them that the agency will not target them.
The Department of Health and Human Services, which oversees the FDA, did not respond to Ars Technica's request for comment.
The proposal comes as the FDA is re-reviewing a dozen popular but unproven injectable peptide drugs. In 2023, FDA scientists determined that the peptides lacked data on safety and efficacy and posed risks. As a result, the peptides were stricken from a list of drugs that specialty pharmacies, called compounding pharmacies, can make. Compounding pharmacies make customized formulas for drugs.
The drugs have nonetheless grown more popular. Sellers claim, without evidence, that they can improve appearance, boost energy and help heal injuries, among other wellness claims. They are especially popular among the MAHA crowd, and many prominent MAHA figures sell peptide products. Kennedy, a self-proclaimed "big fan" of peptides, vowed to end "FDA's war" on peptides upon taking office.
Key facts
- The FDA submitted an "Interim Access Policy" on peptides for White House review, according to a filing notice on an Office of Management and Budget website; the posting gives no details of the policy.
- People familiar with the proposal told the AP it would give the FDA "enforcement discretion" on certain peptide drugs, letting it skip enforcing current restrictions and reassuring specialty pharmacies they will not be targeted.
- The FDA is currently re-reviewing a dozen popular but unproven injectable peptide drugs; in 2023 its scientists found they lacked safety and efficacy data and posed risks, and they were removed from the list of drugs compounding pharmacies can make.
- Sellers claim, without evidence, that the drugs improve appearance, boost energy and help heal injuries; many prominent MAHA figures sell peptide products.
- HHS, which oversees the FDA, did not respond to Ars Technica's request for comment.
Why it matters
The story pits a political promise against the agency's own scientific findings. Kennedy, a self-proclaimed "big fan" of peptides, vowed to end "FDA's war" on them upon taking office. Meanwhile FDA scientists found in 2023 that the peptides lacked safety and efficacy data and posed risks, which is why they were removed from the compounding list. An enforcement discretion policy would let the agency decline to enforce restrictions that rest on that earlier finding.
Who it affects
Specialty (compounding) pharmacies that are eager to start making these peptides would get an assurance they will not be targeted by the agency, as described by people familiar with the proposal. Sellers of peptide products, including many prominent MAHA figures, and the consumers who buy the drugs are also in the picture. The drugs are injectable, and the source says they may cause harms.
How to use it
There is nothing for a reader to apply yet. The content of the Interim Access Policy is not given; the OMB posting does not describe it. Which specific peptide drugs would be covered is not named, and no date is given for the policy taking effect or for the outcome of the White House review.
How solid is it
The core fact, that the FDA submitted an "Interim Access Policy" for White House review, rests on a filing notice on an Office of Management and Budget website. What the policy would do rests on unnamed people familiar with the proposal who spoke to The Associated Press; their names are not given. The OMB posting itself provides no information on the proposal. HHS did not respond to Ars Technica, and no FDA or White House response is quoted.
Risks and caveats
The policy text has not been described publicly in this report, so "enforcement discretion" is a secondhand characterisation and the final policy could differ. The source says the drugs have not been sufficiently studied to establish safety and efficacy and may cause harms, and that sellers' wellness claims are made without evidence. The FDA is also still re-reviewing a dozen of these injectable peptides, so the outcome of that review is open.
“Kennedy, a self-proclaimed “big fan” of peptides, vowed to end “FDA’s war” on peptides upon taking office.”
— Ars Technica, describing Health Secretary Robert F. Kennedy Jr.