The FDA says it is primarily targeting cosmetics devices for regrowing hair, weight reduction, spider vein removal and dermabrasion, as well as injectable fillers, stating that there should always be clearly defined definitions for these products that should not use the same descriptions as medical devices.
The body warns that a number of devices being marketed in the US have crossed the barrier because, although they are marketed purely for cosmetics purposes and as cosmetics, any intention to diagnose or treat a medical condition or affect the structure or function of the body, makes them medical devices.
In a public notice published on the FDA website this week, the authority refers to the Federal Food, Drug and Cosmetic Act (FD&C Act), which specifies that device manufacturers must obtain marketing clearance for their products before putting them in any retail space.
Different approval for medical and cosmetic devices
The notice also states that this kind of specific clearance or approval is needed for cosmetic products or ingredients, with the exception of color additives.
Likewise, medical devices are also subject to the Quality System Regulation section of the FD&C Act, which cosmetic products do not have to comply with.
The FD&C Act officially recognizes medical devices as being: "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory.”
Likewise, the Act also refers to physiological claims as being any that is “…intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."
FDA has come down hard on anti-aging claims
In recent years the FDA has also come down hard on claims relating to cosmetic anti-aging products, stressing that any manufacturer making marketing claims that emphasize a physiological change of any kind means that the claims fall into the medical realms.
In 2014 the FDA issued warning letters to a number of the biggest players in the market, with bothL’Oréal and Avon being asked to change their labeling and marketing on anti-aging products because anti-wrinkle claims had been judged to touch on the physiological.