To protect consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drugs, devices, and cosmetics.

Fair Packaging and Labeling Act

The FP&L Act was passed by Congress to ensure that packages and their labels provide consumers with accurate information about the quantity of contents and facilitate value comparisons. To ensure that packages and their labels provide consumers with accurate information about the quantity of contents and facilitate value comparisons. 15 U.S.C. 1451-1460 

It shall be unlawful for any person engaged in the packaging or labeling of any consumer commodity (as defined in this chapter) for distribution in commerce, or for any person (other than a common carrier for hire, a contract carrier for hire, or a freight forwarder for hire) engaged in the distribution in commerce of any packaged or labeled consumer commodity, to distribute or to cause to be distributed in commerce any such commodity if such commodity is contained in a package, or if there is affixed to that commodity a label, which does not conform to the provisions of this chapter and of regulations promulgated under the authority of this chapter.

Federal Food, Drug, and Cosmetic Act

he FD&C Act prohibits the marketing of cosmetics that are adulterated or misbranded as well as their adulteration or misbranding while in interstate commerce.  Sec. 301, FD&C Act.

A cosmetic is considered misbranded if.....

• labeling is false or misleading
• label does not state
• the name and address of the manufacturer, packer, or distributor
• the net quantity of contents
• the required information is not stated prominently, with conspicuousness and in terms that it is read and understood by consumers under customary conditions of purchase and use
• the container or its fill is misleading

Factors Determining Whether Labeling Is Misleading

Sec. 602, FD&C Act defines the conditions which cause a cosmetic to be deemed misbranded.

Factors Determining Whether Labeling Is Misleading

1. Representations made or suggested
2. Failure to reveal material facts:
3. Material in light of such representations
4. Material with respect to consequences resulting from the intended use

Sec. 201(n), FD&C Act
21 CFR 1.21

Labeling may be considered misleading not only because a label statement is deceptive but also because a material fact is not revealed on a label. A fact may be material in light of a statement made on a label or because certain consequences may result from the recommended use of a product.

Click Here to Download Cosmetic Labeling Guidelines from the

U.S Food & Drug Administration.

Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.

Most currently marketed cosmetics which are also drugs are over-the-counter drugs. Several are new drugs for which safety and effectiveness had to be proved to the agency before they could be marketed. A new drug is a drug which is not generally recognized by experts as safe and effective under the conditions of intended use or which has become so recognized but has not been used to a material extent or for a material time under such conditions.

The regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. For example, the FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations as codified at 21 CFR 210 and 211.New Paragraph