In my quest to understand regulations that much better1 I’m delving even deeper into FDA regulations on cosmetics. So yes, another regulations series from me.
I am reviewing this time some of the layman’s documents provided by the FDA, in this case, their user-friendly document Is it a Cosmetic, a Drug, or Both?
What jumped out at me was this statement:
The FD&C Act does not recognize any such category as “cosmeceuticals.” A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law. ((emphasis my own.)) I found this entertaining because US Vogue in particular has been obsessed with “cosmeceuticals.” Apparently they’re once again chasing after the Emperor’s latest outfit.
In a nutshell, unless the FDA tests and approves it, you can’t say that a product is good for any given condition in any customer communication whatsoever, whether that be verbal, in print, on the Internet or anywhere else. So when someone makes a lotion for treating excema they cannot legally say it is for treating excema even if every study under the sun actually concludes that the tea tree oil in the lotion helps the condition. So, for instance, that dandruff shampoo? The FDA had to approve it before it could be sold as “dandruff shampoo.”
But this isn’t where it stops. If a product is commonly used a certain way, it will be considered a drug - even if the producer doesn’t have those expectations. Toothpaste with fluoride is named as a specific example of this. So if the public is aware of a certain chemical frequently used for a specific cause, the cosmetic will be classified as a drug regardless of the intended use of the producer (although there is probably a process involved.)
Most difficult among these guidelines is the following:
“Consumer perception, which may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do.”‘
Now that’s difficult - it means that if people begin swearing by, say, Tiger Balm for its healing properties, then Tiger Balm becomes classed as a pharmaceutical even if no such claims were ever issued by the originating company. It basically makes all cosmetics producers responsible for what their customers may say about the product.
Since perception is a grey area, I’m curious as to what is required to fit a given legal definition.
- though word of written law is so enormous and changeable that 100% familiarity is unlikely [↩]
