News Date
January 12, 2023
The MoCRA introduces new specifications for manufacturers and processors of cosmetics, gives the FDA additional enforcement power and mandates mandatory recalls, among other modifications.
Cosmetics that are both drugs and cosmetics according to the FDCA are subject to the law. All products that fall under the drug and cosmetic categories are exempt from these new regulations and FDA oversight, with a few exceptions.
Specific reporting, manufacturing procedures, registration, substantiation, labelling, and record-keeping requirements are included in the new MoCRA rules. The "Responsible Person," defined as "the manufacturer, packer, or distributor of a cosmetics product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act," is responsible for complying with the majority of these requirements.
FDA is given mandatory recall authority under MoCRA if it finds that, the use of or exposure to such a cosmetic "would result in serious adverse health consequences or death," and if there is "a reasonable risk that it is adulterated or misbranded."
FDA can request access to any record related to a cosmetic product if it believes it is adulterated.
Additional provisions like Preemption, Talc containing cosmetics, PFAS in cosmetics, Animal testing and FDA Appropriations was explained.
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