FDA 이야기 #011 — 콜롬비아 커피 브랜드가 웹사이트에 'FDA Approved'라고 적었다. FDA가 알아챘다.

A producer in Essaouira, Morocco, made virgin argan oil — cold-pressed, unrefined, the real thing. In Morocco, argan oil is used interchangeably for cooking and for skin and hair care. The same oil. The same bottle. Different uses.

They were selling it into the US through two channels: a specialty food distributor who placed it in gourmet shops as a cooking oil, and an e-commerce platform where it was listed as a hair and skin treatment. Same product. Same SKU. Same label.

문제

In the United States, a food product and a cosmetic product are regulated under entirely different frameworks. A food requires food facility registration under 21 CFR Part 1. A cosmetic requires facility registration and product listing under MoCRA. The labeling requirements are different — food requires a Nutrition Facts panel, allergen declarations, and net contents in specific formats. Cosmetics require an ingredient list in descending order of predominance, net contents, and distributor information.

The company had one FDA food facility registration. They had no MoCRA registration. The product being sold as a hair treatment was an unregistered cosmetic with a food label. The product being sold as a cooking oil was missing the Nutrition Facts panel because the label had been designed to work for both uses — and ended up working for neither.

해결

We split the product into two SKUs with two separate labels. The culinary argan oil received a compliant food label: Nutrition Facts panel, ingredient list, net contents in US customary and metric, allergen declaration (tree nut — argan is classified as a tree nut under FALCPA), and country of origin. The cosmetic argan oil received a compliant cosmetic label: product identity, ingredient list with INCI names, net contents, and manufacturer information. We registered the facility under both the FDA food facility registration and MoCRA cosmetics registration, and listed the cosmetic product.

Two labels. Two registrations. One facility. Compliant on both sides.

교훈

If your product can be used as both food and cosmetic, you need separate labels and separate registrations for each use. A single multi-purpose label that tries to cover both categories will comply with neither. If you produce a product that crosses categories — oils, butters, herbal extracts — talk to us before you design the label. fdabridge.com/contact.