U.S. FDA Report (September 2024): 88 Batches of Imported Cosmetics Rejected

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)

In July 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 72 batches of imported cosmetics from 17 countries. 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.

Thailand led the list of countries with the most rejections, followed by India, South Korea, Canada, and the Dominican Republic.

Country/Area of OriginThe rejections spanned eight product categories, with hair preparations being the most frequently rejected, accounting for 24 batches—over a third of the total. Oral hygiene products were the second most frequent category, with 22 batches, also representing more than a third of the rejections. Makeup preparations and skincare products each accounted for 11.11% of the rejections.

Non-compliant product categoriesThe primary cause for these rejections was the misclassification of drugs as cosmetics, among which 22 batches refused entry because they did not meet drug GMP requirements. Additionally, another 16 batches were flagged as "unapproved new drugs." Other reasons for rejection included labeling deficiencies, color additive violations, and various health and hygiene concerns.

Reasons for non-compliance (Top 10)