US health department to allow temporary sale of some unapproved peptides
The White House-reviewed plan would let specialty pharmacies sell certain peptides with safety guardrails after FDA staff warned the drugs remain unproven.
- On Wednesday, HHS announced it would exercise "enforcement discretion" for six unapproved peptides, allowing compounding pharmacies to offer them despite the substances not being on the FDA list of permitted ingredients.
- Health Secretary Robert F. Kennedy Jr. argued the policy moves Americans away from unsafe "gray market" products imported from China, though FDA scientific staff opposed the initiative, warning it undermines the agency's safety mission.
- HHS officials initially sought formal regulation but pivoted to enforcement discretion to avoid internal conflict; pharmacies must now source ingredients from FDA-regulated factories and report side effects.
- Shabbir Safdar, executive director of Safe Medicines, denounced the move as exposing Americans to "untested dangerous substances," while Peter Lurie, a former FDA official, warned the agency is "turning a blind eye."
- The policy covers six peptides including BPC-157, TB-500, KPV and MOTS-c while HHS continues working toward formal rule changes supported by the Alliance and other industry groups that recently met with White House officials.
31 Articles
31 Articles
HHS to allow sale of unapproved peptides under review
The Department of Health and Human Services (HHS) will allow compounding pharmacies to manufacture and sell peptides that have not yet been added to the list of approved substances, advancing access to those championed by the “Make America Healthy Again” (MAHA) agenda. The HHS stated in a notice that it would be practicing enforcement discretion…
U.S. FDA scientists are opposing Health Secretary R. F. Kennedy Jr.'s plan to make unproven peptides easier to access, warning of risks and undermining the agency's authority.
My Mother Lode
FDA scientists opposed the Trump administration’s effort to ease peptides access
WASHINGTON (AP) — A plan to give Americans easier access to unproven peptide drugs favored by Health Secretary Robert F. Kennedy Jr. was opposed by most Food and Drug Administration scientific staff members, who had limited input in drafting the policy, according to six people familiar with the policy’s development. The document, which covers certain...
Associated Press News
FDA scientists opposed the Trump administration's move to ease peptides access
Food and Drug Administration scientists didn't support a new policy by President Donald Trump's administration to loosen rules on unproven peptide drugs.
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