Adulteration and Misbranding

What does the law say about the safety and labeling of cosmetics?

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce.

“Adulteration” refers to violations involving product composition–whether they result from ingredients, contaminants, processing, packaging, or shipping and handling. Under the FD&C Act, a cosmetic is adulterated if–

  • “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” (with an exception made for coal-tar hair dyes);
  • “it consists in whole or in part of any filthy, putrid, or decomposed substance”;
  • “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;
  • “its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”; or
  • except for coal-tar hair dyes, “it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)

“Misbranding” refers to violations involving improperly labeled or deceptively packaged products. Under the FD&C Act, a cosmetic is misbranded if–

  • “its labeling is false or misleading in any particular”;
  • its label does not include all required information. (An exemption may apply to cosmetics that are to be processed, labeled, or repacked at an establishment other than where they were originally processed or packed; see Title 21, Code of Federal Regulations, section 701.9.)
  • the required information is not adequately prominent and conspicuous;
  • “its container is so made, formed, or filled as to be misleading”;
  • it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act; and
  • “its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.” (FD&C Act, sec. 602)

Under the FD&C Act, a product also may be misbranded due to failure to provide material facts. This means, for example, any directions for safe use and warning statements needed to ensure a product’s safe use.

In addition, under the authority of the FPLA, FDA requires a list of ingredients for cosmetics marketed on a retail basis to consumers (Title 21, Code of Federal Regulations (CFR), section 701.3). Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act. (FPLA, section 1456) This requirement does not apply to cosmetics distributed solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities.

FDA can take action against cosmetics on the market that are in violation of these laws, as well as companies and individuals who market such products.

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