Do I need FDA approval to sell a private label scalp serum in the USA?

Scalp serums sold as cosmetics do not require pre-market FDA approval, but under MoCRA, both your manufacturing facility and your product must be registered with the FDA. If you make drug claims such as treating dandruff or promoting hair regrowth, your product may be classified as an OTC drug, which has stricter requirements. A cosmetic chemist found through AJ Cosmo Labs can help you craft compliant label claims.