US President Joe Biden has signed into law the Modernization of Cosmetics Regulation Act (MoCRA), the first change to Food and Drug Administration (FDA) oversight of cosmetic products since 1938.
MoCRA mandates the FDA to issue manufacturing standards for products, and companies to tell the agency of the ingredients within them and where they are made.
The new law also orders cosmetic manufacturers to report serious side-effects to the FDA, which now has the power to issue mandatory recalls, and disclose allergens on their labels.
MoCRA establishes obligations on the “responsible person”, i.e. the manufacturer, packer, or distributor of a cosmetic and those whose name appears on the products label.
In addition, the new law requires the FDA to issue proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing products; and assess and issue a report regarding use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetics.
The law gives the FDA the authority to suspend the registration of a facility if it determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences and other products manufactured by the facility may be similarly affected.
The FDA also has the power to access records relating to a cosmetic product if it reasonably believes that a product or its ingredients are adulterated and present a threat of serious adverse health consequences.
MoCRA is only applicable to importers and entities that manufacture or process cosmetic products.
