cosmeticdrug

COSMETIC OR DRUG? Is it a cosmetic or a drug and does it make any difference?  It does make a difference.  For starters, cosmetics and their ingredients don’t have to go through an approval process before going to market whereas, drugs do.  You might expect it to be fairly obvious if a product was a drug or cosmetic but it’s not always that clear.  The defining principle is the “intended use” of the product.   If a product is intended to cure, repair, protect, prevent or treat a condition of human or beast, then it’s a drug and needs the approval of the FDA.

Take shampoo for example, it’s a cosmetic that is, unless it claims to treat a condition.  Once it claims to “treat” – it is a drug.  Claiming to add body is much different than claiming to repair hair loss or treat dandruff.   Whether that claim is on the package, on the website or on marketing materials, if it claims to treat a condition, it’s a drug and must go through the approval process or it’s considered adulterated.   Essential oils are getting a lot of attention these days.  Marketing an essential oil for massage can be done under cosmetic rules but if you claim it relieves achy muscles too, that claim makes it a drug.   Many product recalls are attributed to these kinds of benefit claims.

Many labels prefer not to go the route of gaining FDA approval and prefer to go to market as a cosmetic.  Careful consideration to claims and statements can make navigating the process of getting to market, much easier and quicker.

This is a short and simplified explanation of the difference between cosmetics and drugs. There are other considerations that come into play as well.  More on those another day.

MARGUERITE PETIT   ANR Director of Quality Assurance