FDA Panel Clears the Way for 6 Banned Peptides. Here’s What They’re Claimed to Do - Gizmodo

What the report says

Gizmodo reported that the FDA’s Pharmacy Compounding Advisory Committee voted this week to recommend removing six peptides from the agency’s Category 2 list for bulk drug substances used in compounding. The two-day meeting, held July 23 and 24, considered seven substances: BPC-157, KPV, TB-500, MOTs-C, emideltide, semax and epitalon. The panel backed allowing compounded versions of all except emideltide.

The Category 2 list covers substances the FDA considers too risky for compounding pharmacies to prepare, even when ordered by a clinician. According to Gizmodo, career FDA scientists opposed removing the peptides, arguing that the reviewed compounds lacked sufficient safety and effectiveness data. The committee’s recommendations are not binding, but the article notes that FDA advisory panel votes are often influential.

Gizmodo described the peptides as unapproved or lightly regulated compounds promoted for a range of possible uses. BPC-157 and KPV have been studied for healing or anti-inflammatory effects; TB-500 is promoted for muscle and soft-tissue recovery; MOTs-C has been examined in relation to obesity, diabetes and exercise-like effects; epitalon has been studied for aging and insomnia; and semax is marketed for neuroprotective or cognition-related claims and is approved in some Eastern European countries.

The decision matters because it could make these compounds more accessible through compounding pharmacies, despite limited large-scale human trial evidence for many of them. Gizmodo also reported that Robert F. Kennedy Jr. has criticized the FDA’s restrictions on peptides and that new advisory committee members with peptide-industry ties participated in the narrow votes.