FDA scientists said there is insufficient evidence to support loosening restrictions on seven peptides that an advisory panel will review in July, a position at odds with Health Secretary Robert F. Kennedy Jr.
The seven peptides under consideration include BPC-157, emideltide, epitalon, KPV, MOTS-c, semax and TB-500, and agency scientists flagged a lack of published human studies and potential safety concerns for several of the substances.
The Pharmacy Compounding Advisory Committee is scheduled to meet on July 23 and 24 to review the evidence for those peptides and is expected to reconvene in February to consider additional substances, with reviewers set to evaluate proposed uses such as ulcerative colitis, wound healing, obesity and migraines.
In April, Kennedy reclassified 12 peptides as Category 1 substances, the first step toward allowing compounding pharmacies to make them; Kennedy has said he has used peptides on injuries with "really good effect."
The FDA on Monday published the names of nine new advisory committee members appointed to four-year terms; some of the new members own or work at wellness centers that promote or sell peptides, and the panel also includes members who work for companies that offer injectable peptides.
In briefing documents, FDA scientists wrote they could not find human studies for TB-500 and KPV, found no published human studies for MOTS-c, and said the evidence for BPC-157 — including a small trial reported only in a meeting abstract for ulcerative colitis — was insufficient; the scientists also said they could not rule out safety issues and were unsure what version of each substance was being evaluated.
Dr. Anita Gupta said previous committee reviews presented adverse event data showing "a risk of immunogenicity — immune reactions — and that raised some red flags for the committee." She added, "Studies have begun to show that there are significant issues with some of these products. Some of them have heavy metals. Some have microbial contamination. Some are mislabeled." C. Michael White said, "It’s a really big deal if the advisory committee ends up striking out on its own," and warned of a potential double standard in evidentiary expectations.
The seven peptides were originally nominated by LDT Health Solutions, Inc. and the Wells Pharmacy Network, which later withdrew their nominations, but the FDA chose to evaluate the substances anyway; the agency makes the final decision after advisory committee recommendations and often follows the advice of its panels.