FDA故事 #002 — 越南海鲜工厂失去注册资格14个月而不自知

A cosmetics company based in Istanbul had built a strong brand across Turkey, the Gulf states, and parts of Eastern Europe. They made high-quality skincare — moisturizers, serums, cleansers, eye creams. When a US distributor approached them about entering the American market, they assumed the process was similar to what they had done in the EU: register the facility, list the products, comply with labeling rules.

They were right about most of their product line. But one product — their bestselling daily moisturizer — had a problem they never anticipated.

问题所在

The moisturizer contained SPF 15 sun protection. In Turkey and the EU, sunscreens are cosmetics. In the United States, any product with an SPF claim is an over-the-counter drug regulated under the FDA's sunscreen monograph (21 CFR Part 352). This is not a technicality. It is one of the most fundamental classification differences between US and EU cosmetics regulation.

As a drug, the moisturizer required drug establishment registration under 21 CFR Part 207, an NDC Labeler Code, drug product listing in SPL format, a Drug Facts panel on the label (not a cosmetic ingredient list), compliance with the OTC sunscreen monograph for active ingredients and concentrations, and annual user fees under GDUFA. The company had none of these.

解决方案

We classified their entire product portfolio — 23 SKUs — and identified which products were cosmetics under MoCRA and which crossed into drug territory. The SPF moisturizer was the only drug. We gave them two options: remove the SPF claim and reformulate as a cosmetic moisturizer, or register as a drug establishment and list the product as an OTC drug. They chose to drop the SPF claim for the US market and reformulate with a non-SPF version. We then registered their facility under MoCRA, listed all 22 remaining cosmetic products, and reviewed their labels for US compliance.

如果不处理会怎样

If they had shipped the SPF moisturizer to the US as a cosmetic, the product would have been an unapproved new drug — one of the most serious violations in the FDA's enforcement framework. The FDA routinely issues Warning Letters for this exact scenario, and Warning Letters are published on FDA's public database, searchable by any potential US buyer. A single product with the wrong classification could have poisoned their entry into the entire US market.

If you sell skincare, haircare, or personal care products and you are not sure whether any of them are drugs in the United States, that is the first question to answer — before you register anything. Visit fdabridge.com/cosmetics or fdabridge.com/drug.