Skin care products: is it a cosmetic or a drug?
- Posted on: Mar 2 2011
Skin care products: did you know that the difference between what makes a cream you apply a cosmetic and what makes it a medicine is a legal matter? It’s not straight forward, but here is some insight.
The Food and Drug Administration (FDA- the government body that regulates these things) defines a cosmetic as something we use for cleansing, beautifying, promoting attractiveness, or altering the appearance [FD&C Act, sec. 201(i)]. This would include products such as make up, hair dyes, skin moisturizers, shampoo or toothpaste. Drugs, however, are, in part, defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals [FD&C Act, sec. 201(g)(1)]. It comes down to the the intended use of a products. And some products might fall under both categories, such as a dandruff shampoo (intended to both cleanse and treat a medical condition) a moisturizer with sun protection, or a cleanser that treats acne.
Another important difference is that a drug has to prove that it works cosmetic products don’t. When you put on make up, if you like how it looks, it has done its job. The standards are a little different if the product is claiming to get rid of wrinkles. If the wrinkle is still there it’s still there. This gets tricky as some products such as anti-aging creams that market themselves as changing the structure and function of the skin are making drug claims but are categorized as cosmetics they don’t have to prove that they work. Sometimes it just comes down to the language of the marketing.
A good rule of thumb is that if you are expect a specific, measurable result, look for an active ingredient that has been shown in scientific studies to deliver that result.
What about soap? Soap is a whole other category. A soap must be primarily alkali fatty acids (yes, we’re getting into chemistry) and be marketed only as soap. If it claims to do other things, such as moisturize, then it is a cosmetic.
In summary, if the skin care product has proven impact it will likely be categorized as a drug. If it does not it would be a cosmetic.
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