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FDA Labeling Requirements for Cosmetics

The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed, or graphic matter on or accompanying a product. The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper.
FP&L Act requires cosmetics to have ingredient labeling, a statement of the net quality of ingredients, and a principal display panel to the outer container of the product. Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with these requirements may be considered misbranded and may be subject to regulatory action. Below are the most important aspects of labels for cosmetics:

The principal display panel (PDP) is the part of the label most likely displayed or examined under customary conditions of display for sale. 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.
  • 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. Cosmetics of less than 1/4 av. oz. or 1/8 fl. oz. are exempt from a declaration of net contents. Examples of Net Quantity Statements are “Net Wt. 6 Oz.” or “6 oz. Net Wt.”

An information panel must also be included on the outer packaging of a cosmetic product. This panel should include basic information on where the product is manufactured, directions on how to properly use the product, and the ingredient used to make it. 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.
  • 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.
  • Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. 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. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings. An example of such hazardous products is flammable cosmetics.
  • Ingredients. If the product is sold on a retail basis to consumers, even if 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. 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.

Declaration of Ingredients

Cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration. Cosmetics not customarily distributed for retail sale, e.g., hair preparations or make-up products used by professionals on customers at their establishments and skin cleansing or emollient creams used by persons at their places of work, are exempt from this requirement provided these products are not also sold to consumers at professional establishments or workplaces for their consumption at home.

The ingredients must be declared in descending order of predominance. Color additives and ingredients present at one percent or less may be declared without regard for predominance. The ingredients must be identified by the names established or adopted by regulation; ingredients accepted by the FDA as trade secrets exempt from disclosure may be stated as “and other ingredients”.

  • Cosmetics which are also drugs must first identify the drug ingredient(s) as “active ingredient(s)” before listing the cosmetic ingredients.
  • All label statements required by regulation must be in English and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase.

Warning Labels

Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. The statements must be prominent and conspicuous. Some cosmetics must bear label warnings or cautions prescribed by regulation. Cosmetics in self-pressurized containers (aerosol products), feminine deodorant sprays, and children’s bubble bath products are examples of products requiring such statements.

Although the FD&C Act does not require that cosmetic manufacturers or marketers test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement:

“Warning–The safety of this product has not been determined.”

The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.

The safety of a cosmetic can adequately be substantiated by:

  • Reliance on available toxicological test data on ingredients and similar products, and
  • Performance of additional toxicological and other testing appropriate in the light of the existing data. Please note that even if the safety of each ingredient has been substantiated, there usually still is at least some toxicological testing needed with the formulated product to assure adequate safety substantiation.

 

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