What Would Cause a Cosmetic to Be Considered Misbranded?

Below is a basic overview of what makes a cosmetic product misbranded.  Labeling regulations are very complex. Detailed information on cosmetic labeling is available in FDA’s Cosmetic Labeling Manual and the labeling regulations themselves [21 CFR 701].

Section 602 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be considered misbranded.

Under the FD&C Act, the term “misbranding” applies to:

  • False or misleading information
    • “Misleading” includes considering both what the label says and what it does not say.
  • Lack of required information
    • The extent to which the labeling or advertising fails to reveal facts with respect to consequences which may result from the use of the product
  • Conspicuousness and readability of required information
    • If words or statements are not prominently placed on the label so that they will be read and understood by an ordinary person under normal conditions of purchase and use
  • Misleading packaging
    • Misleading container presentation or fill (example – making the container much larger than necessary for the quantity)
  • Improper packaging and labeling of color additives
    • It contains a non-permitted, or in some instances non-certified, color additive
  • Deficiencies where the Poison Prevention Packaging Act requires special packaging.

The label must contain:

  • The name and place of business of the manufacturer, packer, or distributor
  • An accurate statement of the quantity of the contents in terms of weight, measure, or count

**Please note that there are variations and exemptions for small packages.