The draft proposal, published in the US Federal Register, establishes a two-week public comment period to enable pharmacies to compound specific amino acid chains into medications. An FDA advisory panel previously voted in July to ease restrictions on the drugs, even though agency staff members formally advised against the move. These wellness substances, including BPC-157 and TB-500, have experienced a surge in consumer demand despite lacking clinical trials verifying influencer claims of muscle building and rapid healing.
Key points
Compounding pharmacies will soon be permitted to prepare medications using six previously…: Compounding pharmacies will soon be permitted to prepare medications using six previously restricted peptides after a brief public comment window.
The policy shift directly fulfills Kennedy's previous promises to reverse federal crackdo…: The policy shift directly fulfills Kennedy's previous promises to reverse federal crackdowns implemented during the Biden administration.
Medical authorities warn that consumer use of these injectable substances carries serious…: Medical authorities warn that consumer use of these injectable substances carries serious unknown risks due to an absence of human clinical trials.
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- Published
US Health Secretary Robert F Kennedy Jr. has released plans to loosen restrictions on controversial peptides.
The plans, which were announced in the US Federal Register on Wednesday, say Kennedy would allow compounding pharmacies to prepare six popular peptides, which not been approved by the Food and Drug Administration (FDA).
In an unusual move, the draft came from the office of the health secretary rather than the FDA. After the plan has been officially published later this week, there will be a two-week public comment period.
Unregulated injectable peptides have become popular online. Experts have warned of their lack of clinical trials for humans and unknown long-term effects.
The peptides mentioned in the plan include BPC-157, TB-500, KPV, MOTS-c and Semax. Compounding pharmacies will be able to mix them to create medications.
The BBC has contacted the FDA for comment.
An FDA advisory panel voted in July to loosen restrictions on the six peptides. But FDA staff members recommended against it.
Kennedy has described himself as a "big fan" of the drugs and has previously vowed to ease…
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