2012 Single-Serve Fruit Beverages in the U.S.

Additional Information

• A Food and Drug Administration (FDA) that was quiescent during the Bush Administration has sharply stepped up its profile under President Obama, sending a shockwave in March 2010 when it issued a flurry of warning letters targeting both familiar brands, like POM Wonderful and Nestlé children’s drinks, and up-and-comers like the organic kids’ drink First Juice.



• The FDA accused POM Wonderful of making statements on its Web site that POM products can be used “in the cure, mitigation, treatment, or prevention of disease,” which is forbidden for products that are not approved as drugs.



• In September 2010, the Federal Trade Commission (FTC) sued the company on similar grounds, charging that POM’s ads for its juices and POMx supplements contain “false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer and erectile dysfunction.” The FTC also sought an order that would require POM Wonderful to get approval from the FDA for any future disease-prevention claims.



• POM for its part had filed a lawsuit against the FTC two weeks earlier alleging in part that FTC regulations violate POM’s First Amendment rights. In USA Today, Lynda Resnick stated that the FTC is on a “witch hunt” and that the company is clearly making “health claims” and not “disease claims.”



• In May 2012, a FTC administrative law judge issued a ruling that rejected the FTC’s argument that POM would have to provide documentation of double-blind placebo-controlled human clinical trials before it made any health claims – stating instead that such claims would merely have to be supported by “competent and reliable scientific evidence.” Thus, POM Wonderful’s structure/function claims such as “support prostate health” and “promote erectile health” were permissible under this standard.



• However, the judge also ruled that POM Wonderful’s claims that pomegranate juice can prevent or treat heart disease, prostate cancer and erectile dysfunction were not supported by “competent and reliable scientific evidence” and issued a cease-and-desist order that prohibited the company from making such claims for the next two decades. Both parties appealed.