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 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.