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DC Circuit: POM Wonderful's Health Claims Were Deceptive
Practical Law Legal Update 6-598-5925 (Approx. 5 pages)
DC Circuit: POM Wonderful's Health Claims Were Deceptive
by Practical Law Commercial
| Law stated as of 03 May 2016 • USA (National/Federal) |
The US Court of Appeals for the District of Columbia recently affirmed a decision by the Federal Trade Commission (FTC) that the makers of POM Wonderful pomegranate juice products made false, misleading and unsubstantiated health claims in violation of the Federal Trade Commission Act (FTC Act).
On January 30, 2015, in Pom Wonderful, LLC v. Federal Trade Commission, the US Court of Appeals for the District of Columbia affirmed an order from the Federal Trade Commission (FTC) finding that the makers of POM Wonderful pomegranate juice products deceptively advertised their products by making unsubstantiated health and disease claims (Pom Wonderful, LLC v. Federal Trade Commission, No. 13-1060, (D.C. Cir. Jan. 30, 2015)).
This resource was updated on May 3, 2016 to reflect the Supreme Court's decision not to review the case (see Update).
Background
In 2010, the FTC filed an administrative complaint against POM Wonderful, LLC and related parties charging them with violating the Federal Trade Commission Act (FTC Act) by making false, misleading and unsubstantiated health claims about their products. POM produces, markets and sells various pomegranate-based products. Between 2003 and 2010, POM advertised that medical studies have shown that daily consumption of its products could treat, prevent or reduce the risk of heart disease, prostate cancer and erectile dysfunction.
In 2013, the FTC found POM and the related parties liable for deceptive advertising and violating the FTC Act (In the Matter of Pom Wonderful LLC and Roll Global LLC, (F.T.C. Jan. 16, 2013)). The FTC's 2013 order enjoins POM and the related parties from:
- Making misleading and inadequately supported claims about their products' health benefits.
- Claiming that their products treat or prevent any disease unless those claims are substantiated by at least two controlled and randomized human clinical trials demonstrating statistically significant results.
A study is controlled if it includes a group of patients receiving the purported treatment and a separate control group to provide a standard by which results observed in the treatment group can be evaluated. Study participants should be randomly assigned to the treatment and control groups. Randomization increases the likelihood that the treatment and control groups are similar in relevant characteristics, so that any difference in the outcome between the two groups can be attributed to the treatment. Randomization also prevents the investigator from introducing bias into the study.
For more background on this 2013 decision, see Legal Update, FTC Commissioners Uphold Bar on POM Wonderful's Health Claims.
Outcome
The DC Circuit affirmed the FTC's ruling that POM:
- Violated the FTC Act by making false and misleading representations about its products.
- Cannot claim a causal relationship between consumption of its products and the treatment or prevention of any disease without evidence from a controlled and randomized human clinical trial study.
However, the court found that the FTC did not present adequate justification for requiring at least two randomized and controlled human clinical trials as a precondition to a disease-related claim.
POM's Health Claims Were Deceptive
The court found that the FTC had substantial evidence to conclude that POM's advertisements and health claims were deceptive due to inadequate substantiation. In its 2013 order, the FTC found (and the DC Circuit agreed) that experts in the relevant fields would require one or more properly randomized and controlled human clinical trials to establish a causal relationship between a food and the treatment, prevention or reduction of risk of heart disease, prostate cancer or erectile dysfunction. The studies that POM relied on for its advertising claims, however, were not randomized or controlled human clinical trials. Therefore, its claims were not properly substantiated.
The DC Circuit also affirmed the FTC's decision that POM's advertisements and claims about the health benefits of its products contained many omissions of material facts. POM failed to make adequate disclaimers about the studies upon which it relied. For example, when making claims about the health benefits of its products against:
- Heart disease, POM promoted the favorable results of one relatively small study without noting the contrary findings in later and larger studies.
- Prostate cancer, POM consistently relied on the results of one study without noting its limitations or mentioning that the study participants had already received treatment for their prostate cancer before participating in the POM study.
- Erectile dysfunction, POM relied on study results that used a statistically unreliable measure for assessing erectile function, but did not mention that the study showed no improvement according to a recognized, statistically reliable measure.
The court acknowledged that randomized clinical trials can be costly and prohibitive. An advertiser can still assert a disease-related claim backed by medical evidence that falls short of a randomized clinicial trial. However, the advertiser must then include an effective disclaimer disclosing the limitations of the supporting research.
Required Number of Clinical Studies
While the DC Circuit agreed that an advertiser must use a randomized, controlled, human clinical study to substantiate disease-related claims, it disagreed with the FTC's ruling that an advertiser must have at least two such studies. The court found that the FTC failed to justify a categorical floor of two trials for any and all health claims.
The court stated that a categorical bar against claims about the disease-related benefits of a food product or dietary supplement in the absence of two studies can undermine the goal of providing consumers with useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease. For example, if a supplement's disease-related claim were supported by a large-scale, perfectly designed and conducted trial (one that experts in the relevant field universally regarded as conclusively establishing clinical proof of the supplement's benefits for disease prevention), the FTC's order would still bar those claims because of the two test requirement.
Practical Implications
This case clarifies that if an advertiser wants to make a claim about a product's capacity to treat, prevent or reduce the risk of contracting a disease, it must substantiate that claim with a human clinical trial that is both properly:
- Controlled.
- Randomized.
If an advertiser is relying on medical evidence that falls short of a randomized clinicial trial, it must adequately disclose in its advertisements the limitations of that supporting medical evidence. Failure to properly substantiate a disease-related claim or to disclose material facts about any limitations of supporting evidence makes a claim false and misleading and in violation of the FTC Act.
Update
On May 2, 2016, the Supreme Court of the United States denied POM's request for the court to review the D.C. Circuit's ruling. The denial is further proof that the company will be held responsible for deceptively advertising that its products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction, without the requisite clinical proof.
For more information on the FTC's consumer protection powers, see Practice Note, FTC Consumer Protection Investigations and Enforcement.