Overview

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, click here to order the Labeling Manual.

General Labeling Requirements: The Basics

• False or misleading label representations will render a cosmetic misbranded. (Section 602(a) of the FDC Act.)
• Labeling required by or under the FDC Act must be prominent and conspicuous. (Section 602(c) of the FDC Act.)
• A cosmetic label must bear a declaration of each ingredient in descending order of predominance, except that fragrance and flavor may be listed as fragrance or flavor. (Section 701.3 of the FDA regulations.)
• Words, statements and other information required by or under the FDC Act must appear in English if the product is marketed in the United States. (Section 701.2(b)(1) of the FDA regulations.)
• If a cosmetic product is marketed in a U.S. territory where the predominant language is one other than English, the predominant language may be substituted for English (e.g., products marketed solely in Puerto Rico may be labeled in Spanish). (Section 701.2(b)(1) of the FDA regulations.)
• If the label or labeling of a cosmetic product marketed in the U.S. contains any representations in a foreign language, all mandatory information under the FDC Act must appear in the foreign language, as well as in English. (Section 701.2(b)(2) and (3) of the FDA regulations.)
• If cosmetic manufacturers partially process or pack an unfinished cosmetic product, they lawfully may ship the product to another establishment for processing, labeling, and repacking without fully complying with the adulteration and misbranding provisions of the FDC Act. (Section 701.9 of the FDA regulations.)

SOURCE: The Personal Care Products Council Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Ninth Edition 2013.

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.
• 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.

SOURCE: The Personal Care Products Council Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Ninth Edition 2013.