Last week, the Federal Trade Commission issued its
much-anticipated ruling in the agency's case against POM
Wonderful. In a unanimous 5-0 decision, the Commission found that
Pom's advertisements touting the amazing health benefits of its
pomegranate juice and supplements were false. Finding that
Pom's deceptive advertising was "serious and
deliberate," the Commission issued a 20-year injunction that
bars Pom from making disease-treatment or prevention claims for any
products, unless supported by "two randomized,
well-controlled, human clinical trials."
But the Commission stopped short of giving FTC prosecutors all of
the relief they had requested. In a decision that should give some
comfort to food and supplement makers, the Commission ruled that
Pom is not required to obtain FDA's prior approval before
making health claims for its products in the future.
Commission Finds 36 Pom Ads Deceptive
FTC filed suit against Pom in September 2010, alleging that 43
of Pom's ads conveyed false messages that its products are
proven to treat, prevent, or reduce the risk of heart disease,
prostate cancer, and erectile dysfunction. Following a full
evidentiary hearing, an Administrative Law Judge held that 19 of
the ads conveyed false disease-treatment or prevention messages.
The ALJ further found that Pom's scientific
"research" suffered from significant flaws and could not
serve as competent and reliable substantiation. But the ALJ
rejected the FTC's position that all disease-related claims for
foods and supplements require randomized clinical trials like those
routinely done by drug manufacturers.
Both Pom and FTC appealed to the full Commission. Based on its own
examination of the 43 disputed ads, the Commission found that 36
were false and misleading - 17 more ads than the ALJ had found
unlawful. All 36 ads, in the Commission's view, combined
references to clinical research, heart health, prostate health, and
erectile dysfunction in ways that reasonably conveyed that
Pom's products treat or prevent disease.
Pom had argued that its ads only conveyed that its products
provide general health benefits. The Commission disagreed, ruling
that Pom's reliance on parody, humor, and qualifiers such as
"may" in its ads did not dispel their false
disease-treatment and prevention messages.
Randomized Clinical Trials Required For Disease Claims, Even For Foods
The Commission disagreed with the ALJ's conclusion that
randomized clinical trials are not required to substantiate
disease-treatment and prevention claims for foods and supplements.
In the Commission's view, only human clinical trials are
sufficient to support such impactful health-related claims. Thus,
according to the Commission, the fact that such studies are
prohibitively expensive for most food and supplement manufacturers
to perform is not a reason to hold foods and supplements to lower
substantiation requirements.
The Commission did not decide whether food and supplement makers,
in general, need one, two, or perhaps even more randomized clinical
trials to support disease-treatment or prevention claims. But in
light of the serious health conditions referenced in Pom's ads,
and Pom's history of intentional deception, the Commission held
that Pom must have at least two randomized clinical trials before
it makes future claims regarding disease treatment or
prevention.
FDA Pre-Approval Not Required
In recent years, the Commission has resolved false advertising
cases against other food and supplement makers with consent decrees
that, as a "fencing in" remedy, require the companies to
obtain FDA approval before making disease treatment or prevention
claims in the future. The FTC staff sought to impose the same
requirement on Pom, but the Commission balked.
The Commission offered little explanation for its decision not to
require FDA pre-approval in this case, but by not ordering this
remedy, the Commission was able to sidestep Pom's serious
objection that FTC had exceeded its statutory authority by
requiring FDA pre-approval in earlier cases.
Conclusion
This fight is far from over. Pom has already stated that it intends to appeal the Commission's decision in federal court. But the decision is yet another reminder that food and supplement makers will be held to a high standard when touting the health benefits of their products or ingredients in advertising to consumers. FTC's crackdown on unsubstantiated disease claims for foods and supplements continues.
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