What's in a Claim?

Written By:
Risa Schulman, Ph.D., president of Tap-Root
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Supplement sales are booming, and more than ever consumers are looking to make their purchases armed with understanding.

The news introduces a dizzying array of new information every day about the benefits of both time-honored and new-on-the-scene supplements to enhance health. Even the bottles can be confusing, with their strange sounding messages: "May help maintain prostate health," or "May help maintain healthy glucose levels already in the normal range."  What? 

This is the world of the structure function claim. This language on the labels is actually dictated and monitored by the FDA, and what you see is the company trying to communicate the benefit of the product within the confines of the law. It is worthwhile to understand the process of designing claims, and its limitations in order to better communicate to consumers about supplements and what they see on the label.

DSHEA
The funny language began to appear on labels in the mid to late-90s, following the 1994 passing of the Dietary Supplement Health and Education Act (DSHEA), which set forth guidelines for how health benefits of supplements could be described. Back then, wild claims involving cancer cures, rapid weight loss and such were rampant and required no substantiation. This was in contrast to the highly regulated drug industry that was required to spend many millions to say, "lowers blood cholesterol," or "prevents flare-ups."

FDA classifies these claims as "drug claims," and includes anything that prevents, treats or cures a disease. So in order to differentiate from drugs, supplements had to have their own language. DSHEA was an attempt to find a middle ground that allowed supplements to say something, but to keep them off the turf of pharmaceuticals. 

The result was the idea that a supplement alters the structure or function of the body, but does not prevent, treat or cure a disease. This means it can only talk about affecting a normal (not a disease) process. Thus the phrases, "healthy glucose levels already in the normal range," or the "maintenance of heart health."  No mention of disease. 

Science
To be able to say even that, the product must have science to back up the claim. The amount of science has always been a matter of debate that has only gotten hotter with time. But the structure function claim, for all its cryptic vagueness, should have real science behind it. The percentage of companies that take this seriously is growing with every passing day. This is due to not only tighter enforcement by the FDA, but also to the explosion of class action suits, which can be just as costly and damaging as an FDA fine. There is also a greater sense of responsibility overall.

What Companies Do
Responsible companies start by making a review of the scientific studies assessing the effects of the given ingredient or product. This includes studies published by others and studies conducted and published by the company itself (more rare, but definitely increasing as time goes on). 

Ideally, it's best to have at least one or two human studies since claims based only on animal studies are a bit of a stretch, not to mention inadequate from a regulatory point of view. The results of the studies then dictate what claim language can be supported.

And then here's the rub: taking the science and communicating it to the consumer takes a lot of ingenuity. First, you sometimes have to explain very sophisticated and unfamiliar health effects in a few lines of copy.  Second, you often cannot use the most obvious language to do that. Third, you also often cannot directly mention the studies supporting the health benefit. 

So, how do you differentiate your product when all you can say boils down to the same phrases everyone else has to use as well? It's very frustrating. Some companies find some savvy product design and copy, while others give up trying. Many companies use less-constricting communication outlets such as press articles or third-party websites, in which the health effects and the studies supporting them can be mentioned explicitly.

What You Can Do
One important way to help the customer understand the benefits of supplements is to educate yourself and your staff. Some companies provide this education, and those third-party websites, books and press articles can also help. In this way, you can help consumers read into the labels to truly understand how the product can help them and how real those claims are (or sometimes are not). It also helps you to keep up with the fast evolving supplement world.

Risa Schulman, Ph.D., is a functional food and dietary supplement expert, professional speaker and writer.  She is president of Tap~Root, a consulting company focusing on health claim substantiation, product development and business strategy.  Drawing on 15 years of experience on the leadership teams of companies such as POM Wonderful, Solgar Vitamins and Mars Botanical (a division of Mars, Inc.), she assists prominent and pioneering food and dietary supplement companies, ingredient suppliers and companies shifting into these spaces to straddle the science-regulatory-marketing challenges of product development and launch.   
 

Comments

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