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H1 2024 Review: U.S. FDA Rejects 697 Batches of Imported Cosmetics

The majority of non-compliant cosmetics originated from Côte d'Ivoire. Skin care preparations were the most frequently rejected category, followed by personal cleanliness, hair, and makeup products. The primary reasons for non-compliance were the misclassification of drugs as cosmetics and labeling deficiencies.

The U.S. Food and Drug Administration (FDA), under the authority of the Food, Drug, and Cosmetic Act (FD&C Act), is empowered to detain any regulated product that appears to be non-compliant. Upon detention, the FDA district office issues a "Notice of FDA Action" to the product's owner or consignee, detailing the nature of the violation. The recipient is then given the opportunity for an informal hearing to present testimony regarding the admissibility of the product. If the owner fails to demonstrate compliance or submit a corrective plan, the FDA issues a final "Notice of FDA Action" refusing the product's entry, after which the product must be exported or destroyed within 90 days.

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