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.