Summary of Refusal of Imported Cosmetics by FDA in the First Half of 2025
From January to June 2025, the U.S. Food and Drug Administration (FDA) refused entry to 474 batches of cosmetics, a decrease of 220 batches year-over-year.
In terms of rejected categories, skincare products accounted for 128 batches and were reported the most, including facial, body, hand care products, and moisturizers, etc.
From the perspective of origin, over half of the rejected cosmetics are produced in Asian countries, involving a total of 274 batches. Among them, South Korea, India, China, and Japan account for nearly 90% of of Asian refusals and ranked as the top four source countries overall.
Upon closer examination of the reasons for rejection, 55.1% of cases in the first half of the year were due to the product not meeting the U.S. definition of cosmetics or dual-regulated as drugs. The frequent occurrence of labeling and color additive non-compliance in the past is still the main cause of violations, respectively affecting 30.6% and 24.5% of cosmetics exported to the U.S.
Specifically in China, the FDA rejected a total of 67 batches of Chinese cosmetics this year, an increase of 29 batches compared to the same period last year, accounting for a significant increase in the overall proportion from 5.5% to 14.1%. Monthly data shows that the proportion of Chinese cosmetics in rejected batches has increased almost every month compared to the same month last year, showing a gradual upward trend.
From a regional perspective, the rejected cosmetics in the first half of the year were mainly produced in Zhejiang, Guangdong, and Hong Kong SAR. Compared to the same period last year, there has been a different increase in rejected cosmetics related batches in the above-mentioned regions. In addition, it is necessary to pay attention to certain manufacturing companies that have been notified by the FDA and have faced consecutive monthly refusals.
Chinese cosmetics, such as eye shadows and face powders, are the main categories of rejected cosmetics, involving more than 60% of the batches. Body and facial painting products in children's face and body paints are also a common rejected category, with a total of 6 batches in the first half of the year.
In terms of violations, many cosmetics in China have been refused entry by the FDA due to issues with color additive and labeling. The addition of unsafe pigments or improper labeling of pigments are the core reasons for the rejection of cosmetics in China. In addition, there are many cases in Taiwan, China where cosmetics exported to the U.S. are food, drugs or medical devices.
As the U.S. cosmetic regulations (MoCRA) undergo significant updates, companies should pay more attention to product compliance management to cope with the new regulatory requirements of the FDA.
