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Enforcement of the far-reaching cosmetic regulations underscores the Administration’s desire to get it right the first time.
December 11, 2023
By: TOM BRANNA
Chief Content Officer
The cosmetics industry has been waiting for federal regulation reform— it will have to wait a bit longer. As reported in Happi, implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has been postponed for six months. The compliance date has moved from Dec. 29, 2023 to July 1, 2024. The US Food and Drug Administration (FDA) calls MoCRA “the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.” And rightly so. For example, MoCRA gives FDA access to certain records related to a cosmetic product, including safety records. MoCRA also gives FDA the authority to order a mandatory recall if the responsible party refuses to do so voluntarily. MoCRA establishes new requirements for industry including adverse event reporting, facility registration (updated every two years), product listing (updated annually) and safety substantiation. MoCRA also requires that industry comply with regulations that FDA will establish for Good Manufacturing Practices, fragrance allergen labeling requirements, and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. With that kind of depth and weight, it makes sense to make sure every facet of MoCRA is working smoothly. That includes the launch of Cosmetic Direct, FDA’s electronic submission portal. Read More: Prepare for the Modernization of Cosmetics Regulation Act Beauty industry trade groups, with multinational and independent members, applauded the postponement. At the time of the announced postponement, the Personal Care Products Council said it: “Supports the U.S. Food and Drug Administration’s (FDA) announcement to exercise enforcement discretion on Modernization of Cosmetics Regulation Act’s (MoCRA) facility registration and product listing compliance deadline for six months.” PCPC provided feedback to the FDA on the development of an efficient electronic submission program and recognizes that the FDA’s development of Cosmetics Direct is ongoing.
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