A little research goes a long way, especially for the marketing and R&D departments of companies. Last week, NutraIngredients-USA invited a panel of experts in the health and wellness industry to discuss ‘How Far Claims Can Go’ in the blood sugar management space.
Two attorneys on the panel, Justin Prochnow of Greenberg Traurig LLP and Ivan Wasserman of Amin Talati Upadhye LLP, gave us the lowdown on the common pitfalls and questions of marketing and substantiation claims in the category.
Here are some highlights from our Q&A session [edited for style and length]:
NIUSA: Per FDA rules, can you tell us what words we can use in claims for blood sugar management, and which words manufacturers and marketers should be careful with, or steer clear from.
IVAN: For foods or dietary supplements, the main rule to remember is you can’t claim to treat, cure, or prevent a disease—we’re going to sound like a broken record here. So diabetes is a disease, no one is going to debate that. You can’t claim to prevent, treat, or cure that.
Blood sugar is not a disease, right? Everyone has blood sugar. If you didn’t, any doctors on the call will know you’re not doing good if you don’t have any blood sugar… And the same thing is true for cholesterol, the same thing for blood pressure. We all have it, we all need it.
[FDA] considers some things are so entwined in consumers’ minds with disease and prevention that you can't make those claims. So what FDA considers a claim for reducing blood pressure to be associated in the mind with hypertension so you can’t say that—same with blood sugar, associating it with lowering blood sugar levels, FDA will take it as a drug claim because you are implying treatment or prevention of the disease diabetes.
BARRY RITZ (Atrium Innovations): Could you comment on insulin not as a drug? For example, “healthy insulin function in the body" or “maintaining insulin sensitivity,” “healthy insulin receptor function”?
IVAN: I think that’s a great question. Obviously it’s all consumer perception. It’s FDA’s perception, but FDA is trying to step into the mind of the consumer. So the initial point, you’re right, you need to make sure that the consumer understands you’re not talking about the drug.
And then I think, you know, I didn’t research it excessively for this call, but I do think that FDA would be hard-pressed if it’s clear to consumers that you’re talking about maintaining a healthy insulin function in already healthy people.
I know in inflammation they sort of push back on healthy inflammatory response claims, but I think for—as long as you are careful not to imply treatment and prevention of diabetes, you can carefully craft those.
AUDIENCE: For the US market, one cannot do clinicals on a disease population while they are the target consumer. How can ingredient manufacturers develop [clinical trials] to resolve this dichotomy?
JUSTIN: I’m not sure that I agree with the initial statement, that you can’t have a study done on diseased population. I mean part of that depends on what use the clinical study is going to be at the end. And I know obviously there have been some recent decisions that address this.
But obviously you can’t—I know it’s pretty hard to assess maintaining blood sugar levels within normal limits—but it’s pretty hard to measure a healthy population. It’s hard to come to realistic conclusions through measuring totally healthy people.