In today’s video, we discuss how FDA can find that your dietary supplement or cosmetic deserves to be regulated as a “drug,” which means you can’t sell your product unless you get premarket, New Drug Approval from FDA. 

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group.  We’ve counseled over a thousand clients on FDA and other healthcare matters, whether they involve dietary supplements, cosmetics, OTC drugs, medical devices, or medical services, including in the larger health and wellness space.  By the end of this video, you’ll understand how FDA can use a legal rule known as “implied claims” to find that your product isn’t a dietary supplement or cosmetic at all, but rather, is a drug. 

The first thing to know here is that claims can be either express, or implied.  A claim is express when it says something very clearly.  For example: “this product stops headaches.”  In this statement, the manufacturer or distributor is “telling it like it is:” this product does something very specific, which is to stop, or treat, your headache.   

Now, an express drug claim is a direct statement that a product diagnoses or treats a disease.  For example, “chemotherapy shrinks tumors.” Here are some more: “reduces arthritis pain;” “protects against development of cancer.” 

An implied claim is a claim that is “suggested” by giving the statement, and everything surrounding it, a reasonable read.  So, for example, the claim, “herbal Prozac,” suggests that the product is equivalent to taking the drug Prozac.  Simply calling it “herbal Prozac” doesn’t take away the implied claim. 

As another example: I market a product with an image which shows a man before, and after, taking the product.  Before, he is bald, and after, he has a full hair of head.  The implied claim is that the product will restore his hair. 

As you can see, claims can be implied not only by language, but also by images surrounding the claim. 

Next, when you make “drug claims,” also known as “disease claims,” then FDA regulates your product as a drug, even if you meant the product to be sold as a dietary supplement or cosmetic. 

Some claims are drug claims simply because the claim is one normally covered by an over-the-counter (OTC) drug, and/or because there is a regulation describing the subject matter of the claim.  For example, there are OTC monographs on OTC drugs marketed to treat insomnia.  So according to FDA, if you say that your product: “helps you fall asleep if you have difficult falling asleep,” then you’ve made an implied drug claim—even if you only include herbs in the product formulation. 

Last, FDA says that there are least 10 different ways that your product can make a disease claim. 

(1) You say that the product has an effect on a specific disease of class of diseases. 

(2) You say that your product has an effect on the characteristic signs or symptoms of a specific disease or class of diseases—for example, shrinks tumors (where tumors are a characteristic sign of cancer). 

(3) You say that your product has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm.   

(4) You say that your product has an effect on a disease or diseases through one or more factors such as the name of the product.  For example, “Diabet-Eaze,” sounds a lot like Diabetes.   

Similarly, in one warning letter, FDA stated that the name of the product (“HG/EF Hair Growth Enrichment Formula”) “is an implied drug claim because it claims to affect the structure or function of the body, namely hair growth.” 

Also included here is citation of a scientific reference to the disease itself.   

This is powerful as many companies try to reference the scientific literature to show that their products are supported by science; but this itself creates a disease claim. 

(5) You say that your product belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease. 

(6) You say that your product is a substitute for a product that is a therapy for a disease.  For example, if you say that your product is herbal Prozac, you’re suggesting that the consumer can use your product instead of Prozac, the drug, which suggests that your product has the same effect as the drug.  

As another example, in a warning letter to in Scientific Botanicals Company, FDA cited as evidence that the products were being intended for use as drugs, claims that the dietary supplement was for “alopecia.”   

(7) You say that your product augments a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases.  

(8) You say that your product has a role in the body’s response to a disease or to a vector of disease. 

(9) You say that your product treats, prevents, or mitigates adverse events associated with a therapy for a disease.   

And then there is number (10), the catch-all.  Your claim “otherwise suggests an effect on a disease or diseases.”  This number (10) gives FDA enforcement discretion to tag your claim as a disease claim. 

For example: in warning letters to Freedom Plus Corporation, FDA cited these claims as disease claims: “strong weapon against thinning … slow growing and depleted hair,” “stops hair loss from continuing,” “shown to help new hair growth,” “his hair is growing back and he is no longer finding hair in the sink after combing.”   

There are some subtle regulatory distinctions in this market.  For example, FDA has stated that a claim about “hair loss associated with aging” generally would be an acceptable structure/function claim for a dietary supplement; however, claims about alopecia, baldness, hair regrowth, and so on are drug claims.  You can find these kinds of subtle nuances all over the laws governing marketing of dietary supplements.  And one of these things we do as FDA legal counsel, is review the implied disease claims and make recommendations that take advantage of those nuances that help a company’s marketing, without necessarily running the FDA enforcement tripwire. 

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