Efforts to modernize cosmetics regulation under the law known as MoCRA go beyond makeup
Over half a year after Congress passed a law modernizing the regulation of cosmetics in the U.S. (the Modernization of Cosmetics Regulation Act or "MoCRA"), the U.S. Food and Drug Administration ("FDA") has released draft guidance addressing two significant parts of the law: cosmetic facility registration and cosmetic product listing. The takeaway from the guidance is "stay tuned." The FDA states it intends to make a new electronic portal available for submitting registration and product listing information in October 2023.
In the meantime, folks involved in the cosmetic industry should determine whether they are a "responsible person" and/or "facility" under MoCRA. A "responsible person" is "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label[.]" A "facility" is "any establishment . . . that manufactures or processes cosmetic products distributed in the United States." If they are and no exemption applies, they should start gathering the information that will be required for cosmetic facility registration and cosmetic product listing. The cosmetic facility registration will ask primarily for contact information and general category information about the cosmetics produced at a particular facility. The cosmetic product listing will ask for more specific information about the responsible person's cosmetic products – including a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors.
Recall that "cosmetics" are more than just makeup – "cosmetics" is defined as "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap." FDA provides a list of proposed cosmetic product categories in Appendix A, which illustrates the breadth of the products that fall under the definition of "cosmetics."
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