Data from Nielsen’s Ailment Survey reported that 48 million US households have ailment sufferers who manages with diet. Additionally, 60% of US consumers said they “actively make dietary choices to help prevent health conditions, such as obesity, diabetes, and high cholesterol.”
For the supplements industry, the key word here is ‘manages,’ attorney Ivan Wasserman, a partner at Amin, Talati, and Upadhye LLP, told NutraIngredients-USA. “Under FDA [US Food and Drug Administration] rules, at least, FDA considers a claim to reduce blood sugars that were elevated to be a diseases treatment claim,” he said.
“It implies to consumers the treatment of diabetes, which is a disease,” he added (hence, brands should also stay away from putting the word diabetes on pack and other marketing material). “So even though ‘blood sugar’ is not a disease—it’s something we all have, just like cholesterol or blood pressure—FDA considers claims to reduce those things to be disease claims, because they consider ‘blood sugar’ to be connected in consumers’ minds to diabetes.”
Instead of lowering or increasing, acceptable claims within the existing regulatory framework communicate maintaining current levels of healthy blood sugar, he said.
Functional food versus dietary supplements
There are also different things to consider when making a claim for a functional food or a dietary supplement. “If it’s a food product, it’s supposed to be tied to the nutritive value of the food, where that requirement is not mandatory for a dietary supplement.”
What’s the nutritive value of a food? “It’s a term that the FDA hasn’t well defined, it’s something to do with the food value in sustaining life, sustaining nutrition, the easy example is calcium builds strong bones, calcium is sort of a necessary ingredient.”
Substantiating your blood sugar management claims
Aside from FDA rules, companies and brands should also pay attention to advertising laws and Federal Trade Commission regulations. The agency is responsible for overseeing whether or not brands are substantiating the claims they make.
“The FTC generally requires for a health claim like [blood sugar management] to have ‘competent and reliable scientific evidence,’” Wasserman said. “Typically in the form of a placebo-controlled human clinical trial. So for a dietary supplement, you can certainly see that being the model.”
But there’s a common pitfall. “Typically, you’d want to do studies like that on people with diabetes, but if you do that, the question then becomes ‘Do you need an IND [Investigational New Drug application] to do the study because you’re treating sick people,’ and if the claim will then be translatable to the general population, so you have to be very careful with that,” he added.
We’ll be talking more about the category and its common regulatory pitfalls in our upcoming FREE forum
Ivan Wasserman, along with fellow attorney Justin Prochnow, and experts from Nielsen and Atrium Innovations are the panel in our upcoming online forum on the topic. We’ll tackle the category’s issues, ranging from regulatory to scientific to consumer trend analysis. Click HERE to register.
