Recently, FTC came to an agreement with sneaker and clothing company, Reebok International Ltd. This case was brought about because of concerns related to the marketing of a class of sneakers—Reebok Toning Footwear—through television, newspaper, the Internet and other mediums.
Ultimately, FTC and Reebok agreed on a settlement related not only to the sneakers, but all products included in the EasyTone, SimplyTone, RunTone, TrainTone and JumpTone lines. In addition, Reebok agreed that all footwear and apparel that purported to improve or increase muscle tone, strength or activation, including but not limited to, Reebok Toning Footwear and EasyTone apparel, were the core of the marketing and settlement. Are there lessons in this settlement that translate in the dietary supplement world?
Reebok’s Sneaker Claims
In some of its advertisements, Reebok claimed the sneakers/technology were proven to strengthen hamstrings and calves up to 11%, and that they could tone the buttocks “up to 28% more than regular sneakers, just by walking.” Does this type of claim sound familiar to you?
There are many interesting aspects in the Reebok-FTC settlement that are relevant to the dietary supplement industry. For one, this settlement goes beyond Reebok and its employees. In fact, any and all persons or entities (companies, stores, websites, etc.) involved with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any of the products are fully legally responsible for the marketing of the products. In other words, the company that manufactures the product, the company that sells the product, the company that retails the product and the websites that sell the product—and everything in between—are all legally responsible for the truthfulness of the product and its claims. Whew! That’s a lot of people and companies in “the chain of custody” for support of marketing claims.
Reebok’s Case vs. Recent Dietary Supplement/Nutrition Cases
FTC and Reebok agreed that in order for any future claim to be made, it would require competent and reliable evidence for support. The type of study and just how many studies per the FTC-Reebok agreement are needed should raise great interest and spur conversation in the dietary supplement industry.
According to FTC, the evidence should “consist of at least one adequate and well-controlled human clinical study of the covered product that conforms to acceptable designs and protocols, the result of which, when considered in light of the entire body of relevant and reliable scientific evidence is sufficient to substantiate that the representation is true.”
When this is read in contrast to recent FTC settlements with nutrition and dietary supplement companies, there seems to be some discrepancies. First and foremost, the Iovate and Nestle settlements called for at least two well-designed, appropriate clinical trials to support product claims. Why is it that Nestle and Iovate have to have a minimum bar of two well-designed appropriate clinical trials (typically, randomized, double-blind placebo controlled, where possible), while Reebok will only need one clinical trial for its marketing substantiation?
Perhaps it is because the claims made by Reebok were related to muscle toning, muscle activation or ability. Or maybe it is because the claims were considered less egregious compared to those often made for weight loss products.
According to a recent Tan Sheet article, David Vladeck, director of FTC’s Bureau of Consumer Protection, addressed this very issue at a recent conference. He said simply that dietary supplement and drug claims about health and disease prevention might require more substantiation. “The level of substantiation is entirely dependent on the nature of the claim,” he said. Later in the article, he stated, “The stronger the claim and the more the claim talks about issues like disease prevention that our experts and other experts agree cannot be substantiated absent two well controlled studies, then the order requires two well controlled studies…In the Reebok order, we only required one study to make toning and strengthening claims because that is what experts told us would be needed in order to substantiate those ads.”
References furnished upon request.