FTC Commissioners Uphold Bar on POM Wonderful's Health Claims | Practical Law

FTC Commissioners Uphold Bar on POM Wonderful's Health Claims | Practical Law

The FTC recently upheld an Administrative Law Judge's decision that the makers of POM Wonderful pomegranate juice products deceptively advertised their products by making unsubstantiated health and disease claims. The final order requires POM's future disease-related claims to be backed by two randomized, controlled human clinical trials and imposes individual liability on POM's officers who were personally involved in the company's marketing campaign.

FTC Commissioners Uphold Bar on POM Wonderful's Health Claims

Practical Law Legal Update 3-523-8321 (Approx. 4 pages)

FTC Commissioners Uphold Bar on POM Wonderful's Health Claims

by PLC Commercial
Published on 19 Feb 2013 • USA (National/Federal)
The FTC recently upheld an Administrative Law Judge's decision that the makers of POM Wonderful pomegranate juice products deceptively advertised their products by making unsubstantiated health and disease claims. The final order requires POM's future disease-related claims to be backed by two randomized, controlled human clinical trials and imposes individual liability on POM's officers who were personally involved in the company's marketing campaign.
On January 10, 2013 the FTC Commissioners issued an opinion and final order upholding an Administrative Law Judge's (ALJ) decision that POM Wonderful LLC (POM) deceptively advertised its products because it did not adequately support its ad claims. The case originated in 2010, when the FTC filed a complaint against POM alleging that 43 of its ads for POM Juice, POMx Liquid and POMx Pills contained unsubstantiated or under-substantiated claims that the products could treat, prevent or cure serious diseases like heart disease and prostate cancer.
The FTC's final order:
  • Bars POM from making any claim that a food, drug or dietary supplement can diagnose, cure, mitigate, treat or prevent any disease unless the claim is supported by two randomized, well-controlled human clinical trials (RCTs).
  • Imposes individual liability on POM officers for their personal involvement in the company's marketing campaign.

Background

In September 2010, the FTC filed an administrative complaint against POM and its officers alleging that 43 promotional items advertising POM's pomegranate juice products were deceptive, in violation of Sections 5(a) and 12 of the Federal Trade Commission Act. The challenged items included:
  • Print advertisements.
  • Newsletters.
  • Web captures from POM's websites.
  • Internet banner advertisements.
  • Press releases.
  • Media interviews.
The complaint alleged the ads and marketing materials represented that the consumption of certain POM products could treat, prevent or reduce the risk of heart disease, prostate cancer and erectile dysfunction without providing reasonable scientific substantiation. The ads and marketing materials conveyed these claims by using:
  • The word "disease."
  • References to specific diseases or symptoms.
  • Medical imagery.
  • References to physicians and medical research (as opposed to nutritional or other research).
  • References to quantifiable results.
For 19 of the 43 claims, the ALJ concurred with the FTC's complaint, finding the claims false and misleading because they were not substantiated with competent and reliable scientific evidence.
In its appeal, the FTC claimed, among other things, that the ALJ should have:
  • Imposed a substantiation standard requiring RCTs.
  • Required FDA pre-approval of any future POM disease claims concerning the challenged products.
In its appeal, POM argued that its ads convey only general health benefits and not disease claims, in part because its ads use parody, humor and other qualifiers, and therefore do not require scientific substantiation.

FTC Commission Decision and Final Order

The FTC agreed with the ALJ's finding that POM's ads were not properly substantiated, but its decision went further than the ALJ's. The FTC's opinion and order:
  • Expanded the number of ads found to be false or misleading from 19 to 36.
  • Found the ads contained express or implied claims, many of which were serious and deliberate disease treatment or prevention claims, that were not substantiated by sufficiently reliable evidence.
  • Imposed individual liability on those officers who were personally involved in the company's marketing campaign. The final order covers each individual respondent, requiring the individuals to, among other things, notify the FTC if they discontinue their current business or employment or their affiliation with any new business or employment over the next ten years.
  • Did not require FDA pre-approval of any future POM disease claims concerning the challenged products.
Regarding POM's future conduct, the FTC opinion and order also requires that POM:
  • Substantiate its future disease treatment, prevention or risk reduction claims using at least two RCTs.
  • Substantiate its future efficacy or health benefits claims by competent and reliable scientific evidence, which the FTC describes as "tests, analysis, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."
  • Require that POM accurately represent the existence, contents, validity, results, conclusions or interpretation of any scientific tests, studies or research in connection with the sale or promotion of any of its products.
While the FTC's opinion and order apply only to POM's products and advertisements, food and product advertisers should ensure that their ads do not contain any express or implied disease treatment or prevention claims that are unsupported by the stringent substantiation requirements imposed on POM.
For more information on advertising regulations and compliance, see Practice Note, Advertising: Overview.