Drugs and medical devices must obtain regulatory approval before they reach the market but when a cosmetic product is launched there is no requirement to even notify FDA.
Out of design or confusion, products labeled as cosmetics hit the market when they fit the regulatory definition of medical devices or drugs.
The rise of laser devices and products that blur the distinction between cosmetics and drugs suggests that mislabeling is unlikely to go away with potential health implications for consumers.
For those companies caught in a regulatory trap serious financial and marketing consequences can present themselves.
To inform companies about the legal differences between cosmetics, drugs and medical devices and discourage regulatory violations FDA has published warning letters.
For example, in August this year FDA sent a letter to Gaunitz Hair Sciences informing the company that marketing clearance should have been obtained for the THL-1 Handheld Laser.
Threatening regulatory action if prompt action was not taken, FDA explained that the product was a medical device and not a cosmetic because it is intended to be used to diagnose or treat a medical condition or affect the structure or function of the body.
Similar warning letters are published on a separate webpage addressing violations involving cosmetics marketed with drug claims.
Other information has also been published online to help prevent companies from incorrectly marketing their products as cosmetics.
FDA spokesperson Stephanie Kwisnek said: “FDA has made information on the legal differences between cosmetics and drugs readily available on the Web (http://www.cfsan.fda.gov/~dms/cos-218.html).
“In addition, an agreement (http://www.cfsan.fda.gov/~dms/cos-mou.html) between FDA’s Center for Drug Evaluation and Research and Center for Food Safety and Applied Nutrition has been in effect for several years.
“The purpose of this agreement is to gain a more efficient allocation of resources and better coordination of regulatory actions for products that purport to be cosmetics but meet the statutory definition of a drug.”