FDA will refuse entry for items that make medical claims. Ingredients are not as important as the labeling and marketing of the product. For example, if a facial mask has labeling making “anti-acne” claims or lists ingredients that “can balance oil secretion”, FDA will not allow the shipment to clear unless the labeling is removed.
Here are three different types of masks that FDA has refused:
- L-Asorbic Acid Whitening Mask – FDA indicated that the product declares intended use for “whitening.” This is considered a medical claim because it is considered to be altering the structure of the body, namely the skin. Therefore this mask was considered a drug.
- L-Asorbic Brightening Mask – FDA indicated that the product declared intended use for brightening and preventing formation of dark melanin. This mask was also considered a drug.
- Herbal anti-acne mask – FDA indicated that anti-acne claims caused the mask to be considered a drug.
Related: Importing Cosmetics