The US Food and Drug Administration’s staff reviewers have expressed concerns over the risks associated with peptides, citing limited evidence of their benefits. The remarks were made ahead of a July 23-24 meeting of the Pharmacy Compounding Advisory Committee, which will consider whether to add seven popular peptides to the agency’s list of bulk drug substances permitted for use in compounded medicines.

Peptides and Their Uses

Peptides are short chains of amino acids that act as building blocks of proteins and perform essential biological functions in the body. They have gained popularity over the past year, driven by wellness influencers who promote them for various uses, including ulcerative colitis, wound healing, and obesity treatment. However, the FDA staff reviewers noted that evidence supporting peptides’ effectiveness for these uses is scant, and there is a lack of human trials.

The FDA staff reviewers also flagged the lack of human trials and the risks related to immunogenicity, toxicity, and impurity. In 2023, the Biden Administration had barred compounding pharmacies from manufacturing peptides for the same reasons.

Contrasting Views

However, Health Secretary Robert F. Kennedy Jr. has publicly endorsed the use of peptides, stating that he is a “big fan” and has used them himself with “really good effect.” The FDA has also named new members to the panel that will review the peptides, many of whom have ties to peptide-related businesses and clinics.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.