Does the FDA Regulate Your Cosmetics as Drugs?

Does the FDA Regulate Your Cosmetics as Drugs?

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In today’s video, we discuss how FDA regulates cosmetics claims, and the risk that FDA could regulate your cosmetics as a drug. 

Every cosmetics company has to worry about this, because cosmetics claims are very limited by federal law, and in order to market their products, cosmetics companies often want to say a lot more about their products than FDA will allow.  The trick is to navigate the regulatory environment by being somewhat aggressive in your claims, but not so aggressive that FDA will slam you to the regulatory mat.  That’s where legal strategy comes in. 

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve helped cosmetics companies craft their claims—and, respond to FDA warning letters when necessary.  We also help healthcare industry clients with medical devices, dietary supplements, cosmetics, and OTC drugs.  

We’re going to talk about three things:

(1) how FDA looks at your content;

(2) the kinds of claims you can make for your cosmetics products; and

(3) the key difference between claims you can make for dietary supplements, and claims FDA will let you make for cosmetics. 

First, how FDA looks to its net impression of the total content.  Those words are important: net impression, total content.  It isn’t just one thing that you say about your cosmetics product; it’s everything you say, taken as a whole.  And what FDA looks for is the “intended use” of the product: are you marketing the product as a drug, that is, to treat a disease or disease symptom?   

To gather its net impression, FDA looks at all the marketing material, including statements on the label, and, in the marketing materials, including the product website. Even the title of the product can make an implied disease claim.  For example, a claim that the products helps you remove cellulite, regrow your hair, or mitigate symptoms of diabetes. These are all disease or drug claims, and will suggest that the intended use for the product is as a drug. 

Second, FDA allows very limited claims for cosmetics products.  On its website, Are Some Cosmetics Promising Too Much, FDA gives very limited examples of claims cosmetics may make.  These examples are: 

  • Cleanses skin 
  • Enhances beauty 
  • Promotes attractiveness 
  • Alters appearance 

These are very limited categories of claims.  Moisturizing the skin is considered a valid claim, for example, but treating skin warts is not. 

Always remember the legal definition of a cosmetic.  Cosmetics are: “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.”  Again, in a nutshell, all you can say about a cosmetic is whatever falls within this definition: the products are for cleansing, beautifying, promoting attractiveness, or altering the appearance.    

Third, dietary supplements can make structure/function claims, where cosmetics cannot. FDA explains:  

Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.” 

If a cosmetics product makes a structure/function claim, FDA considers that a drug claim. A claim such as “supports the immune system” is a structure/function claim.  Again, you can make a structure/function claim for a dietary supplement, but not for a cosmetic product.  So while you can say, for example, that your echinacea supplement supports the immune system, you can’t stick that same echinacea in a cosmetic and claim that the cosmetic supports the immune system. 

Many cosmetics company miss this distinction, and get in trouble with FDA because the cosmetics manufacturer is making prohibited claims for their cosmetics product. 

Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.    

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