Import Labeling Law

The Basics

• Unless covered by an exemption, every “article” of foreign origin must be marked with the country of origin.

• The country of origin marking must be permanent, legible, and conspicuous.

• “Ordinary containers” not designed for or capable of reuse need not be marked with the country of origin, but “unusual containers” which serve some purpose other than transporting or holding their contents (e.g., fine crystal fragrance flacon) must be marked “Container made in (country).”

• The country of origin designation for imported articles made up of components from different countries, or assembled in a country different from the country of manufacture, is governed by the substantial transformation doctrine.

• For personal care products, a “Made in USA” claim is regulated by the Federal Trade Commission (FTC) and must be truthful, substantiated, and qualified to the extent necessary to prevent it from being deceptive.

• The FDA and U.S. Customs and Border Protection share authority at U.S. ports of entry over imported foods, drugs, cosmetics, and devices. After preliminary examinations by Customs, imports may be released, automatically detained, sampled, or subject to verification by the FDA.

SOURCE: CTFA Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Eighth Edition 2006.