In today’s video, we focus on anti-aging products to determine whether FDA will likely regulate your product as a drug instead of cosmetic.

Hi, I’m Michael H. Cohen, founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients like you, navigate healthcare and FDA legal issues so you can grow your healthcare business.

Previously, in this video series: we’ve talked about FDA’s Intended Use doctrine; the broad definition of “labeling,” and how it includes all of your marketing materials; FDA’s heightened scrutiny for products that make weight loss claims and anti-aging claims; and the fact that you’d rather have your product fall within the regulatory category of cosmetics, if possible, than as a drug or medical device.

We said that your product, to be a cosmetic, can only make very limited claims—such as for example claims to cleanse or enhance beauty—and that your product cannot claim to treat disease nor to affect the structure or function of the body, like skin.

By way of reminder, and we have an entirely different video on this, there are ten different ways a dietary supplement can make an implied disease claim, and those same categories apply to cosmetics.  Remember than an express claim makes a direct statement that a product diagnoses or treats a disease.  For example, “chemotherapy shrinks tumors,” “reduces arthritis pain;” “protects against cancer.”

On the other hand, an implied claim is a claim that is “suggested” by giving the statement, and everything surrounding it, a reasonable read.  So, for example if you call your product “herbal Prozac,” it’s herbal but sounds like Prozac. It’s an equivalent to taking the drug.

Of the ten different ways that a product, be it a dietary supplement or a cosmetic, can make a disease claim and therefore be regulated as a drug, some of the top ones include these.

1. The product names a disease itself, like we said for example, “Herbal Prozac.”
2. The product is intended to cure or mitigate a symptom of a recognized disease.
3. The product is intended to be a substitute for a product that is an approved drug or recognized therapy for a disease.
4. The big catch-all: the product “otherwise suggests an effect on a disease or diseases.” Watch out for that legal term “otherwise,” it means anything else.

This last one is, as we say, big enough to drive a truck through.  FDA finds your product is a drug, whether FDA relies on the intended use doctrine or on this broad catch-all definition of an implied drug claim. Those are the things you need to watch out for.

The implied disease categories are important to know, because companies like to call their products “nutraceuticals,” “cosmeceuticals,” or some other cute name that makes it sound like it’s a “-ceutical”, like a pharmaceutical. But those words themselves are not objectionable, just because they rhyme with “cuticle.”  The issue is whether the marketing claims as a whole imply treatment of disease.  The line between what’s permissible and what’s impermissible can be slippery, so it’s important to get legal review and advice for anything on your website.

Finally, you have to make sure that your cosmetics claims not only don’t make disease claims, but also are capable of substantiation. In other words, you got to be able to prove whatever you say.

Both FDA and the Federal Trade Commission (FTC) require that all statements regarding a product be truthful and non-misleading.  Among other things, this means that the advertiser must have adequate substantiation or underlying evidence of the intended use. Normally, this means the claim must be supported by “competent and reliable scientific evidence.”

We talk about these legal standards in other videos.  The main point in brief is that FTC penalties can be significant and include disgorgement of all profits made over several years from sales of the products.

As general advice to clients, the fewer claims you make, the smaller the target.  The more claims, the more to substantiate. It’s important to remember because companies likes to put lots and lots of claims out there.

Thanks for watching. Feel free to contact us with your questions. We have helped hundreds and hundreds if not thousands of healthcare industry clients just like you build their dream.  We look forward to working with you on the journey to success!