fda warning letter bpc-157 unapproved drug An advisory committee voted Thursday to remove compounding restrictions on four peptides despite little evidence the products are safe or effective for medical use. In a series of 8-6 votes (with Demand for Unapproved Weight-Loss Drug

The one or more hepatocyte growth factor mimics has or have a general structural formula R] -R 2 -R 3 -NH-(CH 2 ) n -C-IS[H2 1 2 3 where Ri is one of an N-acyl group, a substituted or unsubstituted phenyl, a norleucine group, and an amino acid selected from tyrosine, phenylalanine, aspartic acid, arginine, isoleucine, serine, histidine, glycine, cysteine, methionine, tryptophan, lysine norvaline, ornithine, and s-benzyl cysteine

It is clinically employed as an adjunct therapy in infectious diseases, cancers, and immunodeficiency conditions due to its ability to stimulate T cell maturation and modulate both innate and adaptive immune responses 1,3,4 .

The FDA cited the lack of human studies on the peptide and concerns about safety as its rationale

Indian Journal of Endocrinology and Metabolism (2024) 10