General Labeling Requirements

The Basics

• False or misleading label representations will render a cosmetic misbranded. (Section 602(a) of the FDC Act.)

• False or misleading label representations about another cosmetic or a food, drug, or device also will render a cosmetic misbranded. (Section 701.1(a) of the FDA regulations.)

• The name of a cosmetic product may be misleading if it includes or suggests one or more, but not all of its ingredients. (Section 701.1(b) of the regulations.)

• Labeling required by or under the FDC Act must be prominent and conspicuous. (Section 602(c) of the FDC Act.)

• 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).

• 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)(1) of the FDA regulations.)

• Labeling required by the Federal Fair Packaging and Labeling Act (FPLA) (i.e., ingredient declaration and statement of identity) need not appear in the foreign language on a dual-language label for a cosmetic product. (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: CTFA Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising, Eighth Edition 2006.