In today’s video, we talk about more common labeling mistakes that dietary supplement manufacturers and distributors make when creating marketing claims for their products.  We focus specifically on some of the FTC issues and we drill down with examples.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues so you can launch, or continue to scale, your health and wellness product or service. That’s what we do.

The FTC standard for healthcare products as we know, is that these products must be substantiated by “competent and reliable scientific evidence.”  This pertains not only to supplements, but also cosmetics, medical devices, and consumer products that focus on health and wellness.  We talk about dietary supplements because this is the most common area where we see clients get into trouble.

What exactly is “competent and reliable scientific evidence?”

FTC says that “competent and reliable scientific evidence” means: “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

Although there is no pre-established formula as to how many or what type of studies are needed to substantiate a claim, FTC will consider what the accepted norms are in the relevant research fields and consult experts from various disciplines. If there is an existing standard for substantiation developed by a government agency or other authoritative body, FTC may accord some deference to that standard.

In determining whether the substantiation standard has been met with competent and reliable scientific evidence, FTC considers these four factors: (1) the meaning of the claims being made; (2) the relationship of the evidence to the claim; (3) the quality of the evidence; and (4) the totality of the evidence.

Now for some quick examples. If you make a claim that your dietary supplement “supports the immune,” then, as obvious as it sounds, you should have, according to FTC, “a clear understanding of the claim’s meaning to develop endpoints that could be measured and replicated in studies used as a basis for substantiation.”

FTC is specific about what the studies must show.  For instance, the studies being used as substantiation for the dietary supplement claim should identify the same or similar dietary supplement or ingredient and serving size; the same conditions of use; and, among other things, the same “dosage,” the same population.

Further, the claim itself should “accurately convey to consumers the extent, nature, or permanence of the effect achieved in the relevant studies and the level of scientific certainty for that effect.”

If you’re interested in an early read, you would likely benefit from having a Legal Strategy Session with a member of our Legal Team.

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