KEYWORDS: Cosmetics, FDA, health claims

How Many Cosmeceuticals Can Fit on the Head of a Pin?

By Richard Jaffe, Esq.

None, according to the FDA, because there is no such thing.  In FDA-land, there are only regular cosmetics which are essentially un-FDA regulated, and cosmetics that are drugs and regulated as drugs, meaning full-on FDA new drug approval applications.

My guess is that the term “cosmeceuticals” was created from an analogy to nutraceuticals, which are dietary supplements that have some structure/function type of medical application or value. Nutraceuticals exist because DSHEA allows structure/function claims. Cosmeceuticals don’t exist (from a regulatory point of view) because there are no permissible structure/function claims for cosmetics. (More about this later.) So in a way, a cosmeceutical manufacturer is someone who is manufacturing an illegal product but hasn’t been stopped by the FDA yet. That is the theory anyway.

In truth, I’ve always had some reluctance to dive into the FDA cosmetic legal arena because of what I thought was a regulatory disconnect between the law and FDA enforcement actions. But that has changed in the last year or two. Now the FDA is more aggressive in going after manufacturers/promoters of cosmetics who make drug/disease/structure function claims. In the last eighteen months or so, it has sent at least a half dozen warning letters to cosmetics companies making drug/disease/prevention/structure function claims. Warning letters are sent to specific companies, but they also are one of the FDA’s main tools for ensuring compliance with the law amongst the industry as a whole.

What Are Cosmetics?

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)].

Stuff like skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product would all be considered cosmetics.

The problem area to me is the “altering appearance” thing. I don’t think the FDA gives it a very broad meaning, as some examples from warning letters will show.

What’s a Drug?

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)].

A product that makes a structure/function claim is a drug, unless it is a dietary supplement (i.e. ingested as a dietary aid) in which case a structure/function claim is permissible because of an exception to the drug definition contained in DSHEA (the 1994 dietary supplement act).

The important takeaway is that there is no parallel exception for cosmetics (or medical devices). Therefore, based on the functional definition of a drug, if you are a manufacturer of a cosmetic and make a disease/treatment/prevention of disease, or a structure/function claim, under FDA law, you’ve got a cosmetic which is also regulated as a drug. If you don’t have an NDA, you are manufacturing an adulterated, misbranded drug that you are illegally introducing into interstate commerce (or what I call the FDA trifecta, which by the way carries civil and criminal penalties).

What Kinds of Claims Get Cosmetics Manufacturers in Trouble?

Here are a few claims culled from some warning letters: “removes wrinkles instantly; ideal for treating, sun spots, age spots, acne scarring, hyperpigmentation; supports the synthesis of new skin fibers; soothes and reduces redness and irritation; strengthens the skin’s ability to repair and protect itself.”

You can’t circumvent the law by attaching the claim to an ingredient rather than the whole product. For example, the FDA has put the kybosh on claims that an ingredient “works in a similar way to Botox, increases cell communication and gene activation for the skin healing, thus it plays a fundamental role in the reconstruction of the skin tissue, is very high in lignans that support cell communication.” So, cell communication language seems problematical to the FDA. The FDA even took offense with a claim that an ingredient “helps increase skin hydration by inhibiting hyaluronidase.”

Want to increase your odds of getting an FDA warning/cease and desist letter? Use “stem cells” in your product name or advertisements, and then talk about their healing and regenerative powers. The FDA is coming down very hard on stem cell clinics because of false advertising and drug claims, and it has recently issued several stem cell guidance documents, the gist of which is that stem cells are considered drugs.  So, to the FDA, using “stem cells” in a name or advertisement for a cosmetic is like putting a sign on your door, web site, and forehead that you are manufacturing an unapproved new drug, which is misbranded and adulterated.

What About Docs Who Make Disease/Prevention/Structure/Function Claims for Cosmetics?

The good news: The FDA doesn’t normally involve itself with practicing physicians. So unless a doc is selling cosmetics over the internet, the FDA is unlikely to take issue with the promotion.

The bad news:  In the last few years, the state professional boards have given greater scrutiny to advertising by health care professionals for false or unsubstantiated product claims. Basically, whatever a manufacturer couldn’t or shouldn’t say under federal FDA law, usually can’t or shoudn’t be said by a health care provider under state board law. There might be exceptions and extenuating circumstances, but you shouldn’t get into to trouble by following the federal law.

So, a guy jumps off a hundred story building. As he’s passing the 50^th floor, he’s asked how he’s doing. “So far so good.”

Be careful!

Rick Jaffe

rickjaffeesquire@gmail.com