Many believe that Eve offered Adam a pomegranate in the Garden of Eden, and Persephone is said to have eaten the pomegranate seeds offered to her by Hades, forcing her to return to the Underworld for four months each year, plunging the earth into winter (at least until global warming came along.) That tasty little fruit has been at the center of yet another more recent epic tale — this time between the FTC and the folks that make POM Wonderful pomegranate juice. Yesterday the FTC’s ALJ (D. Michael Chappell) released his 335 page Initial Decision in the FTC’s proceeding against POM and the FTC may have won the battle but lost the war (though it will likely be appealed to Mt. Olympus, or rather, the Commission.)
As most of you know (unless you’ve just returned from the Underworld), the FTC has recently begun revising the substantiation requirements in many of its consent orders. Various specific health claims involving foods or dietary supplements in orders such as Nestle and Iovate have required typically two “adequate and well-controlled human clinical studies” of the product at issue or an essentially equivalent product and those studies must be randomized and double-blind and placebo-controlled in most cases. Even the recent sneaker cases have required one such clinical study for the claims at issue. In addition, the FTC has imposed an FDA pre-approval requirement for certain types of claims that it views as “drug” or “disease” claims; for example, the claim in Nestle that any covered product prevents or reduces the risk of upper respiratory tract infections.
In its complaint, the FTC alleged that POM’s ads made deceptive claims that: (i) its products prevented, treated, or reduced the risk of heart disease, prostate cancer, and erectile dysfunction, and (ii) that POM had clinical studies, research and trials to prove those claims. Contentious discovery and an evidentiary hearing that spanned over five months ensued. There were over 3,700 pages of trial testimony, 3,929 proposed findings of fact and 3,936 pages of post-trial briefing.
While the ALJ found for the FTC on all counts, he rejected both of the FTC’s proffered substantiation requirements. Consistent with the FTC’s recent consent order negotiations, complaint counsel argued that all health-related efficacy claims must be substantiated by double-blind, randomized, placebo-controlled trials. (what the ALJ (and we) refer to as RCTs) The ALJ, however, surveyed recent federal court decisions and found no support for this position, instead falling back upon the FTC’s traditional definition that “competent and reliable scientific evidence” should be determined “by what the evidence shows that experts in the relevant field would deem adequate.” Instead, where the underlying product is a food or a nutrient supplement, is safe, and is not being marketed as a substitute for medical treatment, the ALJ held that RCTs are not required.
With respect to the three types of claims at issue — heart disease, prostate cancer and erectile dysfunction — the ALJ found that clinical studies, but not RCTs, were required, holding, for example, that while POM had firm evidence that its product generally promoted erectile health, its evidence that the product prevented, treated, or cured erectile dysfunction was …limp.
Regarding FDA preapproval, Judge Chappell rejected the staff’s proposal that POM seek prior FDA approval before making disease claims going forward, finding such relief unnecessary and unprecedented. Instead, Judge Chappell ordered only that POM have competent and reliable scientific evidence to support such claims. The full Commission will write the next chapter in this epic and perhaps the courts as well since a parallel proceeding, filed by POM in U.S. District Court, had been stayed pending the ALJ’s decision. In the meantime this may heighten resistance to the Commission’s recent attempts to alter its standard substantiation requirements in many of its orders.