Do I need FDA approval to sell a polyglutamic acid serum in the US?

Topical cosmetic serums do not require pre-market FDA approval, but under MoCRA (2022) your manufacturing facility must be FDA-registered and each product must be listed with the FDA. You also need a compliant INCI label per 21 CFR Part 701. AJ Cosmo Labs connects brands with manufacturers and regulatory consultants who handle MoCRA compliance as part of the launch process.