According to the FDA's latest regulatory update, OTC-Drugs, which are products that function as both a cosmetic and a drug, must now comply with the FDA's regulations for both cosmetic and drug products. These products include anti-dandruff shampoos, fluoride toothpastes, antiperspirant deodorants, and foundations that contain sunscreen. If the labeling of these products goes beyond the definition of a cosmetic, the FDA may consider them to be new drugs, and therefore these products must be registered with the FDA when exported to the United States.
In addition, under the Modernization of Cosmetic Regulations Act of 2022 (MoCRA), which was signed into law by President Joe Biden on December 29, 2022, all cosmetics exported to the U.S. must be registered or certified by the FDA.Under MoCRA, existing cosmetics manufacturing facilities must be registered within one year of the enactment of the Act, and new cosmetics facilities must be registered within 60 days of the start of processing and production of cosmetics. Existing cosmetics manufacturing facilities must be registered within one year of the enactment of MoCRA, while new cosmetics manufacturing facilities must be registered within 60 days of the commencement of the manufacturing process. These new requirements aim to strengthen the regulation of the cosmetics industry and ensure that the products used by consumers are safe and effective.
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