Do private label peptide hair serums need FDA approval?

Cosmetic hair serums (non-drug claims) do not require pre-market FDA approval in the US, but the manufacturer must comply with FDA 21 CFR Part 700 series and the Fair Packaging and Labeling Act. If you make drug-adjacent claims like 'regrows hair,' the product may be regulated as an OTC drug. For EU sales, a Cosmetic Product Safety Report and Responsible Person are required under Regulation 1223/2009. AJ Cosmo Labs connects you with regulatory consultants who handle both markets.