Washington, D.C.—Industry members have a lot to learn from the opinions expressed by a U.S. District judge in the case of the United States versus Bayer Corp., according to Steve Mister, Esq., president and CEO of the Council for Responsible Nutrition.
Speaking on a panel during SupplySide West in Las Vegas, Mister called the judge’s opinion “fascinating” and one that all industry members should understand.
The Federal Trade Commission (FTC) had wanted Bayer to conduct randomized, controlled clinical trials on its Phillips Colon Health probiotic before the firm could lawfully say the product helps “Promote Overall Digestive Health" and "Help Defend Against Occasional Constipation, Diarrhea, Gas and Bloating." The judge found otherwise.
FTC had its eye on Bayer because of a 2007 permanent injunction issued against Bayer for its marketing of WeightSmart One-A-Day vitamins. According to court papers, "The 2007 Order requires Bayer to have competent and reliable scientific evidence to substantiate any representation it makes about the benefits, performance, or efficacy of any dietary supplement it markets or sells."
“FTC was trying to rewrite the language of the consent decree,” Mister told WholeFoods Magazine. In the end, the industry can learn several things from the ruling.
First, having two randomized clinical trials in place to support claims is not a set-in-stone requirement for "competent and reliable scientific evidence” for supplements. There is some flexibility, as supplements are not drugs and do not have to adhere to drug standards.
Mister noted that there are certain expectations for applying relevant research to one's product, though. For instance, he stated, “If testing is done with 50 mg of an ingredient, then the finished product needs to have 50 mg to make a responsible claim.” And while well-controlled human clinical trials may be extremely reliable, other types of studies may be appropriate, too, depending on the situation.
In addition, Mister said the judge wants supplements marketers to consider a broader view of their marketing. He explained, “Are you sure you’re not making an implied claim in your marketing?”
The judge also felt that testing on specific finished products is not required to make a claim. “You can use research about the ingredients” to support a claim, Mister stated. But again, there’s the big picture to consider. Mister pointed out, “Are there synergistic effects that could amplify the effects when multiple ingredients are used in the same product?”
Last, Mister suggested that this case may not be over, as FTC has 60 days to appeal the ruling. He said that while FTC has a history of making appeals, “perhaps it won’t do so in this case given the frankness of the judge’s opinion.”
Published in WholeFoods Magazine, November 2015 (online 10/12/15)