Understanding regulations regarding the labeling and packaging of cosmetics and personal care products is critical for anyone manufacturing or distributing products in the United States.
PCPC publishes and maintains the most comprehensive resource on U.S. labeling requirements, the Personal Care Products Council Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Ninth Edition. Last printed in 2013, the Labeling Manual continues to be a must-have resource for anyone selling or producing cosmetics or personal care products, containing current labeling regulations with helpful analysis and graphics displays.
With excerpts from the Labeling Manual, this section takes an in-depth look at U.S. regulations for labeling cosmetics, OTC drugs, and professional products. For a complete understanding of this critical issue, order the Labeling Manual.
SOURCE: The Personal Care Products Council Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Ninth Edition 2013.
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.
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.
The FTC requires “all or virtually all” of a personal care product to be made domestically in order to advertise a “Made in USA” claim.
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.