Rule CG-RFA-006

Regulatory status: what rule CG-RFA-006 checks

Rule CG-RFA-006 is one of the checker's regulatory status rules. It cites 21 CFR 101.93(g). The reason, source and safer wording are below.

CG-RFA-006 · Blocks approval · Citation checked against stored text
Marketing semaglutide, tirzepatide or peptides for weight loss as research chemicals or as the same ingredient as a brand-name drug sells an unapproved new drug and implies equivalence to an approved product.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Do not market compounded or research peptides for weight loss, and do not claim equivalence with Ozempic, Wegovy, Mounjaro or Zepbound.
21 CFR 101.93(g) · Needs counsel review

Next step

Check your copy against this rule

Run the checker and every flag cites its rule and source.