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When does a cosmetic become a drug?

Doffy says…I’m curious as to how companies like FutureDerm and SkinCeuticals are allowed to sell their retinol and vitamin C products. Wouldn’t these products be considered drugs since they change the way the skin behaves?

The Beauty Brains respond:

That is a VERY insightful question Doffy. To be absolutely technically correct (given the strict definition of a drug) then yes retinol products COULD be considered drugs because they affect the physiology of skin. But there’s a LOT of gray area in that interpretation. Whether or not a product is a drug or a cosmetic really comes down to the product claims. Allow me to explain.

What’s the difference between a cosmetic and a drug?

The legal definition of a cosmetic (per the Food Drug & Cosmetic Act) is as follows: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”

A drug on the other hand is 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.”

(In case you’re curious, law does not allow for any category such as “cosmeceuticals.” This term has no legal meaning.)

Therefore how any given product is classified by law really comes down to its claims. Consider the example of a simple massage oil. According to the FDA, the product is a cosmetic if it’s just intended to be rubbed on the skin and smell nice. But if that same product claims to relieve muscle pain, then it’s a drug.

If we said that ANY product which affects the structure of skin is a drug than we’d need a prescription to take a shower because even water affects skin structure by causing it swell (thereby enhancing the ability of certain ingredients to penetrate deeper.) However, I don’t think anyone would argue that water is a drug under the FD&C act.

Do retinol products make radical claims?

So what about the retinol product you asked about? Let’s look at the claims for FutureDerm Time-Release Retinol 0.5. Here are the claims, according to their website. along with our analysis:

Fights fine lines and wrinkles
“Fights” wrinkles is a qualifying term and is a different from “removes” wrinkles which would more likely be a drug claim. I’m sure FutureDerm can provide data which shows that the product reduces the appearance of fine lines and wrinkles which should be adequate to support the “fight” language.

Smoothes mottled or rough skin
Smoothing is a cosmetic claim for skin (just as it is for hair.)

Aids mild to moderate acne
Retinoic acid is a prescription acne drug and retinol has similar properties. The qualifier “aids” should help distinguish this as a cosmetic claim.

Alleviates the appearance of age spots
“Alleviates” and “appearance” are claim qualifiers often used to make it clear that a product is not affecting the structure or function of skin.

Maintains and build skin firmness
Claims around skin firmness have traditionally been considered cosmetic.

So it doesn’t appear in this case that the company is making any claims which would cause their product to be considered a drug. Having said that on occasion we have seen have seen the FDA crack down on cosmetic companies when they go overboard on their anti-aging claims.

(Disclaimer: we are a paid advertiser of FutureDerm but I could do the same sort of claims analysis on any retinol product. I chose this one because you asked specifically about it.)

The Beauty Brains bottom line

The difference between a drug and a cosmetic can be a fine line and is highly dependent upon the claims made by any given product. However, for the most part, as long as there’s no danger of these products harming people then no law enforcement agency is going to go after them for being “illegal drugs.”

Reference: http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm

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