Until recently, US cosmetics law fit on a few pages written in 1938. The Modernization of Cosmetics Regulation Act, signed at the end of 2022, changed that. It gives the FDA real tools: companies must register their facilities, list their products, keep safety records, report serious adverse events, and the agency can now order a recall.

The part that matters most to people reading this site: there is a small business exemption. Makers whose average gross annual sales in the US over the past three years are under $1,000,000 generally don't have to register facilities or list products. The statute (21 U.S.C. 364h) names four kinds of product the exemption never covers: anything that regularly contacts the mucous membrane of the eye, anything injected, anything intended for internal use, and anything that alters appearance for more than 24 hours and is not removed by the consumer. So mascara and eyeliner take you out of the exemption; a lip balm does not.

What the exemption does not do is lower the safety bar, and it is narrower than "exempt from the paperwork" suggests. Even an exempt maker must still report serious adverse events to the FDA, keep the records behind them, hold evidence that each product is safe as used, and carry adverse-event contact details on the label. A cosmetic still has to be safe for its intended use, and labeling still has to be honest.

Soap is its own special case. A true soap, made from oils and lye and sold with cleaning claims only, is regulated by the Consumer Product Safety Commission rather than as a cosmetic. Add a moisturizing or scent claim and it becomes a cosmetic.