MoCRA (Modernization of Cosmetics Regulation Act): meaning for cosmetics brands

What MoCRA requires from a cosmetics brand

FDA describes MoCRA as the most significant expansion of its authority over cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938. The responsible person is the manufacturer, packer or distributor whose name appears on the label, so for a private label cosmetic that is usually the brand owner. Facilities that manufacture or process cosmetics register with FDA and renew every two years. The responsible person lists each product with its ingredients and updates the listing annually.

The responsible person must keep records showing adequate substantiation of safety; FDA notes that animal testing is not required. Serious adverse events must be reported to FDA within 15 business days. The law also gives FDA mandatory recall authority and access to certain records, and directs it to set rules on good manufacturing practice and fragrance allergen labelling; check their status at the time of launch.

There are exemptions for certain small businesses, but they do not cover products such as those used in the eye area, injected, used internally or meant to stay on the body for more than 24 hours. A frequent trap is the cosmetic and drug boundary: products such as sunscreens or antidandruff shampoos are regulated as drugs, or as both, with separate rules.

This is general information about a US law; in a project a licensed US specialist confirms what applies. See private label cosmetics in the USA, the US market and our compliance stage.