In August 2024, the U.S. Food and Drug Administration (FDA) exercised its authority under the Food, Drug, and Cosmetic Act (FD&C Act) to refuse entry to 115 batches of imported cosmetics from 22 countries, a notable uptick of almost 60% from the previous month. The FDA's enforcement actions included issuing "Notices of FDA Action" to product owners or consignees, which specified the nature of the violations. If the recipients failed to prove compliance or provide a plan to rectify the issues, a final notice would be issued, after which the product must be exported or destroyed within 90 days.
Côte d'Ivoire led the list of countries with the most rejections, followed by India, Chinese mainland, Togo, and Germany.
Country/Area of OriginThe rejections spanned nine product categories, with skin care preparations being the most frequently rejected, accounting for 58 batches—over a half of the total. Personal cleanliness products were the second most frequent category, with 34 batches, representing nearly a third of the rejections. Hair preparations accounted for 6.09% of the rejections.
Non-compliant product categoriesThe primary cause for these rejections was the misclassification of drugs as cosmetics, among which 77 batches were flagged as "unapproved new drugs." Other reasons for rejection include color additive violations and labeling deficiencies.
Reasons for non-compliance (Top 10)
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