In today’s advertisements of cosmetics, we hear terms like organic, alcohol free, hypoallergenic, and cosmeceutical, but most of the general public is not informed regarding the definitions and ‘enforcement’ of such terms by the regulatory agencies.
Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices and to help consumers make informed decisions regarding product purchase.
Although it is illegal to introduce a misbranded cosmetic into interstate commerce, some instances do occur. Some of the ways a cosmetic can become misbranded are:
- its labeling is false or misleading,
- its label fails to provide required information,
- its required label information is not properly displayed, and
- its labeling violates requirements of the Poison Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21 U.S.C. 362].
The FDA does not have the resources or authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer’s and/or distributor’s responsibility to ensure that products are labeled properly. The following information must appear on the principal display panel:
- An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
- An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].
The following information must appear on an information panel:
- Name and place of business. This may be the manufacturer, packer, or distributor. This includes the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory [21 CFR 701.12(a)].
- Distributor statement. If the name and address are not those of the manufacturer, the label must say “Manufactured for…” or “Distributed by…,” or similar wording expressing the facts [21 CFR 701.12(c)].
- Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
- Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.
- Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled “For professional use only” or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above. To learn more, see “Ingredient Names,” “Color Additives and Cosmetics,” “Fragrances in Cosmetics,” and “‘Trade Secret’ Ingredients.