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Cosmetics, Drugs, and "Cosmeceuticals" - Oh My!

Jennifer Katehos

Posted on July 06 2017

There are A LOT of skincare products out there -- creams, lotions, serums, and other cosmetics -- all making promises to cleanse, beautify, and alter a person's appearance.  But if a product's marketing promises (purposefully or accidentally) to treat or prevent disease or to change the body’s structure or functions, chances are the product is going to come upon its new greatest foe, the US Food and Drug Administration ("FDA").

Is it a Cosmetic, a Drug... or Both?

 According to the FDA, a skincare product can be either a "cosmetic" or a "drug."

The Federal Food, Drug, and Cosmetic Act ("FD&C Act") defines cosmetics by their intended use, as "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" [FD&C Act, sec. 201(i)].

The FD&C Act defines drugs, in part, by their intended use, 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)].  In practice, includes promises to increase production of collagen and elastin, reduce inflammation, increase or decrease the production of pigment in the skin, regenerate cells, or treat medical conditions, such as acne, rosacea, eczema, psoriasis, and dandruff.

A product can be BOTH a cosmetic and a drug.  For example, an anti-dandruff shampoo is a cosmetic because it is intended to cleanse the hair but it is also a drug because it is intended to treat dandruff.

Why This Matters

The law does not require FDA approval of cosmetic products or ingredients before they go on the market.  Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter Drug Review.  These monographs specify conditions whereby over-the-counter (that is, nonprescription) drug ingredients are generally recognized as safe and effective, and not misbranded. 

Misbranding is detrimental to the consumer, who needs to know when too-good-to-be-true drug claims have not been proven to the FDA.  Some companies may appear to be consciously making a misbranded claim, but some do not; it is surprisingly easy to make a mistake.

What About "Cosmeceuticals"?

You may have heard some companies tout their skincare products as "cosmeceuticals" or as "cosmeceutical-grade," but that is just the ~M~a~G~i~C~ of marketing.  The cosmetic industry uses the term to refer to cosmetic products that have medicinal or drug-like benefits.  The FD&C Act, however, 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.  In other words, any company can make a "cosmeceutical" claim, because it means absolutely nothing.