Updates on Cosmetic Regulations in North America (June)
US FDA Refuses Entry to 89 Batches of Cosmetics
In May 2025, the US Food and Drug Administration (FDA) refused entry to 89 batches of cosmetics from 18 countries.
The countries with the most refusals were India (19), Nigeria (16), and China (12). "Other cosmetics" accounted for the highest proportion, followed by cleaning products and bath soaps. The main reasons for refusal included non-compliant labeling, unauthorized color additives, and failure to comply with new drug application requirements.
For products subject to refusal, if the responsible party fails to demonstrate compliance or provide a corrective plan, the FDA will issue a final notice, leading to re-export or destruction of the products.