Are color additives in cosmetics separately regulated by the FDA?

Yes. Color additives used in cosmetics are subject to a pre-approval process under 21 CFR Parts 73, 74, and 82. Synthetic dyes such as FD&C Red No. 40 require batch certification by the FDA before use. Many cosmetic colorants approved in the EU are not permitted in the US. A cosmetic chemist audits your color palette against the FDA's approved list and flags any unapproved pigments before you finalize your formula—saving you from a potential product recall. Post your brief on AJ Cosmo Labs to find a qualified chemist.