–Susan Perera, Attorney

Last week on Marketplace on NPR, there was an interesting story regarding a FDA crackdown on the beauty industry, particularly on cosmetic companies who have begun to market their cosmetic products using drug-like claims.  (Marketplace audio provided below.)

The FDA appears to be concerned about these “cosmeceuticals” which do more than just claim to beautify, but are advertised as being able to “cure” or change the body’s function.


Apparently, the FDA has identified multiple products, like anti-dandruff shampoo and fluoride toothpastes, that can function as both a cosmetic and a drug based on their intended use.   The FDA’s website says that “intended use” is determined by advertising claims and consumer perception.


So what would be the impact of being classified as a cosmetic versus a drug?  While cosmetics do not require any FDA approval before going to market, drugs are either approved by the FDA prior to hitting the market or must conform to preset rules for a particular drug category.  Further, unlike cosmetics, drugs are required to adhere to good manufacturing practice requirements, and identify their drug formulations to the FDA.


This story again highlights the legal implications of advertising.  On multiple occasions we have discussed how advertisements can land companies in hot water over potentially false advertising claims.  Clearly here, advertising decisions could also have a considerable impact on the entire production and regulation placed on a cosmetic product.  We will be interested in seeing how the cosmetic industry responds to the FDA’s new scrutiny.