The two most important laws pertaining to cosmetics marketed in the United States are the Federal Food, Drug, and Cosmetic Act1 (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action. 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 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 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)
Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if--
- "its labeling is false or misleading in any particular";
- its label does not include all required information;
- 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)
In addition, under the authority of the FPLA, FDA requires an ingredient declaration to enable consumers to make informed purchasing decisions. Cosmetics that fail to comply with the FPLA are considered misbranded under the FD&C Act.
It is important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including FDA, to create and enforce regulations, but only as authorized under the law. A change in FDA's statutory authority over cosmetics would require Congress to change the law.
The attorneys of Rick Ruz, PLLC provide comprehensive client service across the spectrum of legal needs in the cosmetic industry. Clients ranging from startups to multinational corporations benefit from our experience and focus on regulatory issues.
No matter where your company is located in the United States or around the world, our lawyers can advise you about the best ways to protect your interests.