
Cosmetics vs OTC Drugs in the United States
Quick Answer: In the United States, a product may be a cosmetic, an OTC drug, or both. The key question is its […]
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Quick Answer: In the United States, a product may be a cosmetic, an OTC drug, or both. The key question is its […]
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Quick Answer: U.S. cosmetic ingredient rules do not work as one universal “approved ingredient list.” With the exception of color additives, cosmetic […]
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Quick Answer: Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the responsible person for a cosmetic product must report a […]
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Quick Answer: MoCRA requires the responsible person to ensure, and maintain records supporting, adequate safety substantiation for each cosmetic product. FDA does […]
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Quick Answer: Under MoCRA, facility registration and cosmetic product listing are separate FDA submissions. Facility registration identifies a covered manufacturing or processing […]
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Quick Answer: A foreign cosmetic manufacturer may need to register its facility with FDA when it manufactures or processes cosmetic products for […]
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Quick Answer: A cosmetic factory does not need FDA registration simply because it makes cosmetics. Under the Modernization of Cosmetics Regulation Act […]
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Quick Answer: Private-label cosmetics do not receive a single blanket FDA registration simply because they are private label. Under MoCRA, the legal […]
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Quick Answer: There is no single FDA “cosmetics import certificate” that makes every shipment admissible. A U.S.-bound cosmetic shipment needs accurate commercial […]
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