In today’s video, we’ll talk about some not so obvious ways that FDA can classify your dietary supplement as a drug.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients and entrepreneurs navigate healthcare and FDA legal issues and launch, or continue to scale, their health and wellness business.

In a nutshell, manufacturers and distributors can make structure/function claims for dietary supplements, not drug claims.  For example, “calcium builds strong bones.”

In addition, dietary supplement claims may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.”

General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient.

So far so good, but because the lines can be blurry, FDA describes ten ways in which making claims for dietary supplement products can create and imply drug claims.

The most obvious one is the first: the product claims that it has an effect on a disease. For example, if the product claims to protect against cancer, or arthritis, or diabetes, or coronavirus … this is a disease claim.

The second is whether the product claims to have an effect on a symptom of a disease.  For example, if a symptom of leaky gut is digestive trouble, then making claims about alleviating digestive symptoms, could potentially be drug claims.  One possible workaround here is to talk about “occasional” digestive issues.  However, it’s easy to blur the lines so it’s good to have legal counsel to review the claim.

The context matters.  For example, FDA says you could make a claim such as, “maintain cholesterol levels that are already in the normal range.”

Note that words are important, but they don’t tell the whole story because the whole context does.  SO for example, FDA says that even words like “restore,” “support,” “maintain,” “raise,” “lower,” “regulate,” or “stimulate” might create an implied disease claim if, in the context they are used, they imply an effect on disease. Similarly, we know words like “prevent,” “mitigate,” “diagnose,” “cure,” or “treat” – those would be disease claims if the context of their use implies an effect on a disease.

The third criterion is that the product claims an effect on an abnormal condition associated with a natural state or process.  For example, aging is a normal process, and thus, “mild memory loss associated with aging” would be an acceptable claim for a dietary supplement; however severe memory loss is a condition that could be linked to a disease, such as for example, senile dementia. So you cannot make that kind of claim.

Thank you for watching. If you still have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here is to the success of your healthcare venture, we look forward to speaking with you soon.