Is Korean Skincare FDA Approved? Cosmetics Rules in Plain English
The FDA does not approve cosmetics before sale, but MoCRA added new duties for brands and importers. Here is what that means for Korean skincare.
The short answer
The FDA does not pre-approve cosmetics, Korean or American. Cosmetics must be safe, properly labeled and not adulterated. Products that make drug claims, like sunscreen SPF or acne treatment, are regulated as drugs.
What MoCRA changed
The Modernization of Cosmetics Regulation Act of 2022 requires facility registration, product listing, adverse-event reporting and safety substantiation for cosmetics sold in the U.S. Importers and brands share responsibility for compliance.
What it means for you
Buy from sellers who import properly and label in English. Be cautious of products sold with medical claims. Our fake-spotting guide helps.
Frequently asked questions
Are Korean sunscreens legal in the U.S.?
Sunscreens are OTC drugs in the U.S. and need to meet FDA sunscreen rules, which many Korean sunscreens have not gone through.
Does KFDA approval count in the U.S.?
Korea's MFDS regulates products in Korea; U.S. rules apply separately.
This article is for general information and is not medical advice. Products sold by KAREMEDI are cosmetics and are not intended to diagnose, treat, cure or prevent any disease.