Cosmetics

The document from 2018 outlines the regulatory framework for cosmetics in the United States, highlighting the role of the FDA and the distinction between cosmetics and drugs. Cosmetics, which are for cleansing, beautifying, or altering appearance, are regulated by the FDA's CFSAN, while products with therapeutic benefits are considered drugs and fall under CDER's oversight. The FDA does not preapprove cosmetics, and companies are responsible for the safety and efficacy of their products. The document notes the voluntary nature of cosmetic registration, the absence of mandatory adverse event reporting for cosmetics, and the FDA's inability to mandate recalls for cosmetics. It contrasts the U.S. regulations with stricter international standards, such as those in the EU, Canada, and Japan, which require mandatory product notifications and adverse event reporting, and suggests that the U.S. may adopt more stringent regulations in the future.