FDA defines a cosmetic as one article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance. The courts have construed altering the appearance to mean that which provides a temporary effect. In addition, FAD defines a drug claim as any product which claims that it can change the structure or function of the body or that diagnosis, treats, or mitigates any disease. Any cosmetic that makes a drug claim will be considered misbranded and potentially be subject to FDA enforcement, such as being issued a warning letter.
Labelers of cosmetics need to pay close attention to the claims about changing the structure or function of the body. Temporary changes or those claims that the average consumer knows will not be permanent are permissible. It is the claims that imply a product can permanently change “wrinkles”, as an example, that will rise to the level of a drug claim resulting in the cosmetic product being misbranded under FDA regulations.
Websites are subject to either FDA or FTC (Federal Trade Commission) regulations. FTC regulates marketing material and FDA regulates labeling. Courts have interpreted labeling to mean anything that accompanies the product, cosmetic or otherwise, at the “point of sale.” An example is a flyer that is distributed with a cosmetic product when the product is sold at a retail store. In this scenario, the flyer would be considered labeling because it is provided with the cosmetic product at the point of sale and thus subject to FDA regulations. The same flyer would be considered marketing material and subject to FTC regulations instead of FDA when this same flyer is mailed out to potential consumers but is not provided at the point of sale.
Which federal agency, FDA or FTC, has jurisdiction over website content will have a direct impact on the claims that can be made on the website. FDA regulations are more stringent than FTC. FTC bases much of the analysis of whether or not a claim is permissible on marketing material on scientific evidence. Whereas FDA requires specific wording regardless of scientific justification.