FDAストーリー #007 — メキシコのホットソースメーカーが聞いたことのないFCE番号を必要としていた

A K-beauty brand based in Seoul had 23 skincare and makeup products ready for the US market. They came to us for MoCRA facility registration and product listing. We registered the facility, designated ourselves as US Agent, and began listing each product — reviewing ingredient lists, verifying INCI names, checking for prohibited or restricted substances.

Products 1 through 22 passed review without issue. Product 23 — a popular lip tint — did not.

問題

The lip tint contained CI 15510, also known as D&C Orange No. 4. In South Korea, this colorant is approved for use in lip products. In the United States, D&C Orange No. 4 is approved for external use only — it cannot be used in products applied to the lips or in any area where it may be ingested. Under 21 CFR 74.1254, the colorant is restricted to externally applied cosmetics. A lip tint is not externally applied — it is applied to the lips, which is a mucous membrane area.

If the lip tint had been imported into the US and sold with this colorant, it would have been adulterated under the FD&C Act. Import Alert 53-04 specifically targets cosmetics containing unauthorized color additives. A single adulterated product in a shipment can trigger FDA scrutiny of the entire brand.

解決策

We flagged the ingredient during pre-listing review and notified the brand immediately. They had two options: reformulate the lip tint with a color additive approved for lip use in the US (such as D&C Red No. 6 or D&C Red No. 7), or exclude the product from the US market entirely. They chose to reformulate. The new formulation took six weeks. We listed the product with the FDA once the reformulated version was ready.

The other 22 products entered the US market on schedule. The lip tint followed six weeks later with a compliant formula.

教訓

Color additive regulations in the US are completely different from Korea, the EU, and Japan. A colorant that is approved in your home market may be prohibited, restricted, or require batch certification in the United States. This is not something you discover at the border — it is something you check before you formulate for the US market. Send us your ingredient lists at fdabridge.com/cosmetics.