On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD). Continue Reading Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!
Written by: Timothy Slattery
In part two of this two-part series, we explore two critical takeaways for those facing potential government intervention: (1) the implications of the Court’s deference to the Commission, and (2) whether a substantive disclaimer is a silver bullet to avoid agency scrutiny (or, at least, an agency win).
A Second Quick Glance at POM Wonderful
To briefly recap, the District of Columbia Circuit Court of Appeals handed the Federal Trade Commission a critical win on January 30, 2015 by affirming the Commission’s January 2013 decision holding POM Wonderful LLC in violation of the FTC Act for its deceptive advertisements alleging pomegranate juice and supplements could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction. The decision shows the continued reach of the FTC into the scientific bases for health-related advertising, the extensive deference courts give to the agency’s expertise, and that substantive disclaimers may be the only way to avoid liability.
Agency Deference Increases the Commission’s Home-Field Advantage
In this first post of a two-part series, we take a closer look at last Friday’s decision in POM Wonderful v. FTC by the U.S. Court of Appeals for the District of Columbia, which has meaningful implications for how companies advertise their products’ health benefits to consumers. The decision bolsters the Federal Trade Commission’s position that, when a company makes specific claims that its products’ health benefits are scientifically “established,” it must have “competent and reliable scientific evidence” to substantiate these claims–specifically, at least one randomized controlled trial (RCT), the “gold standard” in the medical and scientific fields. A company relying on studies that do not meet this gold standard, like POM Wonderful, risks being charged with false or misleading advertising by the Commission.
For consumer-product companies making health claims–especially in litigation-heavy states like California–the logical next question is whether POM Wonderful somehow exposes them to liability from consumer plaintiffs if they fail to meet the standard articulated in the decision. The short answer is that it does not; POM Wonderful is not likely to “change the game” in the world of private class actions for consumer fraud and false advertising. The reason: what courts and counsel have come to call the “prior substantiation” doctrine. And it has important ramifications for how companies should view and respond to class actions brought in the decision’s wake.