In today’s video, we discuss how one client handled the legal uncertainty regarding the claims he could make for his new dietary supplement, which happened to involve the arena of brain health.  The legal points we’ll cover here could apply to any dietary supplement you’re desiring to put on the market, or redistribute.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry like you clients navigate healthcare and FDA legal issues so they can launch, or continue to scale, their health and wellness product or service.

Jon created a dietary supplement that targets brain health.  He paid for clinical testing and he found out that the dietary supplement is indeed effective in terms of helping people with brain issues like mild cognitive impairment and other geriatric issues.

Jon would like some legal assistance with what kinds of claims he can make for his brain health dietary supplements.  Jon asked our legal team: “What requirements must I meet to make any of these types of claims for my brain health dietary supplement?”

Here, without reviewing anything about this company, a more generalized response:

There are three requirements you have to meet.

First, the law says that you can make structure/function claims if you have substantiation that the claims are truthful and not misleading. You must have this substantiation before you make the claims.

Second, you must notify FDA that you are using the claim within 30 days of first marketing your product.

Third, the claim must include a mandatory disclaimer that you’ve seen in all of the supplements and that’s provided in the law.

Now, going back to the first requirement: What are structure/function claims, according to FDA?

According to FDA, structure/function claims have historically appeared on the labels of conventional foods and supplements as well as some drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.

But Structure/function claims are the most common and they can describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “maintains bowel regularity,” or “antioxidants maintain cell integrity.”

It may not be possible always to draw a totally bright line between structure/function and disease claims. You need look at the objective evidence in your labeling to assess whether a claim is explicitly or implicitly a prohibited disease claim. For example, a statement may not mention a disease but it could refer to other things that are more in the structure/function line. They are very exquisitely laid out by FDA.

But it is important that we keep in mind two things. First, the context of the statement, which we got from information on the label and all other material, is going to be considered. Second, supplements cannot have disease claims, even implied, because if they do, then you’ve got to have premarket review for FDA and you have to have approval as a drug unless there’s a health claim which is a specialized category that we’ll talk about in another place on our blog or in our video.

Understand that FDA includes 10 different criteria to decide whether you have a disease claim which is something you can’t make for supplements. So, there’s 10 different ways and the tenth is a catch-all, so, a lot to consider.

If you’re interested in an early read, sometimes you will do a Legal Strategy Session even for supplements because we can get a quick sense of the claims and get you some basic orientation. But more typically, we want to review the entire label.

Thanks for watching. If you have more questions, check out our blog, cohenhealthcarelaw.com/blog or click on the contact button to send us a message or book an appointment. We look forward to speaking with you again soon.