In today’s video, we discuss how FDA’s Intended Use Doctrine really shapes the potential market for your dietary supplement claims.  We’ll also explain how the Intended Use Doctrine affects your marketing of dietary supplement or cosmetics product.   

The Intended Use Doctrine is a legal rule that anyone should understand if they wish to bring a healthcare product to market. 

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group.  Our focus as a law firm is on the multi-trillion-dollar health and wellness industry, which gives us deep expertise in these various pockets of knowledge that only a specialist can resolve. 

What is the Intended Use Doctrine? 

According to FDA: “Intended use is the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.” 

Let’s unpack that. Intended use is the “objective intent.”  This means that when determining the “intended use” of a product, FDA doesn’t have an x-ray machine that peers into your mind—although some conspiracy-theory-minded healthcare businesses might think so.  What FDA does is decide what someone could, objectively, say is the intended use of your product.  Is the product intended by used, for example, to cure or treat AIDS?  Or is it simply intended to support your overall immunity? 

FDA determines the “objective intent” from several things: 

1. The claims you make in all your marketing. 
2. Everything you say in your advertising. 
3. Oral or written statements you make, or publicly approve of, concerning your product. 

Recently, a client came to us, intending to market their product as a cosmetic.  However, what they “intended” to do in their own minds was different than what the “intended use” looked like from the perspective of “objective intent.” 

Objectively, it looked like they intended to market the product as a drug—because they were marketing the product as a substitute for a well-known drug on the market. 

Marketing a product as something that’s just as effective as a drug, to treat a certain condition, is one of many ways you can make a “drug claim,” also known as a therapeutic claim or a disease claim. 

As another example: if your claim is, “controls blood sugar in persons with insufficient insulin,” an objective person would understand this to mean that your product can be used to treat diabetes, and, can be used instead of a prescription drug. 

You can’t make that product a nutraceutical or dietary supplement, or a cosmeceutical or cosmetics product, simply by saying that that’s what it is.  You might put Dietary Supplement on the label that you stick on the box or bottle or tube; but if you market the product with the claim, “controls blood sugar in persons with insufficient insulin,” then your overall labeling shows an intended use as a drug. 

Claro que si? As we say in Spanish.  Perfectly clear? 

Think about this angle.  You’re a medical doctor, a celebrity, or simply someone who has had a lot of success in another line of business and now you’re getting into healthcare products.  You hire a contract manufacturer to brand a line of dietary supplements, and they assure you that they have their own lawyers—and everything is copasetic, A-OK, legally fine, you’ll slide into revenue Home Plate and be Safe!   

And so you sign the short and sweet contract manufacturing boilerplate contract they’ve designed for you—which puts all the liability and regulatory risk on you, none on them—and presto, they have given you these claims you can put right on your product.  They’ve never had a problem, after all, and you trust them, right?  So why not? 

Your contract manufacturer is not the FDA, and, cannot give you any assurance that your dietary supplement product will be immune from FDA enforcement.  What they say about your claims may not be the law, and, does not bind the FDA.   

Bottom line, when you go to a contract manufacturer, have your claims independently reviewed by FDA legal counsel.  And, what about that contract manufacturing agreement, which so handily comes to you as their boilerplate?  Have that reviewed by your FDA attorney too. 

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