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

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.

In the first half of 2024, the FDA refused entry to 697 batches of imported cosmetics from 36 countries. Côte d'Ivoire led the list, followed by Germany, China, the Dominican Republic, and France.

Country/Area of Origin

The rejections spanned eight product categories, with skin care preparations being the most affected, accounting for 345 batches—nearly half of the total. Personal cleanliness preparations ranked second at 27.4%, followed by hair preparations at 11.62%, and makeup preparations at 6.46%. 

Non-compliant product categories

The leading cause for rejections was the misclassification of drugs as cosmetics. Over half of the 697 batches were refused entry because they were classified as drugs rather than cosmetics. Unqualified labeling was the second most common issue, including failures to list the generic name, non-compliance with the FD&C Act and Title 21 of the Code of Federal Regulations (21 CFR) regulations, and lack of instructions for use. Other reasons for rejection included the presence of unsafe color additives and various health and hygiene concerns.

Reasons for non-compliance (Top 10)