In today’s video, we talk about when your product is likely to cross the line and be regulated by the federal Food & Drug Administration (“FDA”) as a cosmetic and not a prescription or Over the Counter (“OTC”) drug.  Obviously, you’d rather be cosmetic as it’s less expensive.

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

Tom has Product X which he would like to market to help people with let’s just say, a certain skin condition that he has himself. He wants to call the product, basically something like “Skin Condition X-Away.”  Is FDA likely to regulate this as a cosmetic, or as an OTC drug?  Obviously, again, if it’s a cosmetic, the barrier to market entry is much lower.  And if it’s a prescription drug then the barrier is astronomical.

FDA looks to the “intended use” of the product, which FDA gleans from reviewing all the product claims, whether on the physical label of the product, or in the name, or in the online and print marketing materials. Everything is labeling.

The federal Food, Drug & Cosmetic Act (“FDCA”) defines cosmetics as: “articles intended to be rubbed, poured, sprinkled, sprayed upon, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

The purpose of the product has to be “beautifying, cleansing, promoting attractiveness, or affecting the appearance.”  Anything else, the product is going to be classified as a drug.

On its webpage entitled, “Are Some Cosmetics Promising Too Much,” FDA gives a few limited examples of claims cosmetics manufacturers can make: cleanses skin; enhances beauty; promotes attractiveness; and alters appearance.  That’s it, folks – that’s all she wrote. Very limited, yet it’s a huge industry.

Products regulated as “drugs” typically do one of the following in their claims. (1) They suggest that the product is intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease.” Or (2) they suggest that products are “articles intended to affect the structure or any function of the human body.”  Those are pretty big categories, especially if you think about skin.

Unlike dietary supplements, cosmetics cannot make “structure/function claims.”

On FDA’s webpage, “Is It a Cosmetic, a Drug, or Both?” FDA notes that a product can meet the definitions of both cosmetics and drugs, by having two intended uses (such as a shampoo that is also intended to treat dandruff, or toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protective claims). Such products must comply with the requirements for both cosmetics and drugs.

FDA gives as examples of drug claims: “claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.” Also: claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles.

And claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery. Those are drug claims.

Other drug claims might be promises to treat medical conditions, like acne, rosacea, eczema, and psoriasis.

If your product falls into any of these general categories, that’s it, you’re making drug claims.

Sometimes clients come to us and say: “Wait a minute, look at all these other claims companies are making, look at this stuff, they’re selling it everywhere, how come we can’t do that?”

Listen, you can if you want to.  We can’t block you; we don’t control your website.  We’re here to advise you, and, if you run afoul of FDA, you’ll pay the price.  We just want to give you the best advice possible. FDA can enforce criminally, if warranted; it can also order you to stop selling; and its cousin FTC, the Federal Trade Commission, can actually require you to disgorge unlawful gains.  Now that sounds very noble, right? What it means for you is that you pay all your profits back to your customers, so you’re left with nothing.

So … to quote the great American philosopher, Clint Eastwood: are you feeling lucky?

Seriously.  Don’t mess with claims.  Get proper legal advice, ideally before you put a product on the market, not once you’re in the regulatory crosshairs with a warning letter, although we handle that too.

Thanks for watching. Please contact us with your questions. We have helped thousands of healthcare companies just like you build their dream.  We look forward to working with you on your journey toward success!