The legal battle between POM and the FTC is being followed closely by food/supplements manufacturers and lawyers alike as it addresses broader questions over free speech as well as the substantiation required for health claims.
FTC: POM claims are not supported by science
In its administrative complaint filed in September 2010, which POM has dismissed as “completely unwarranted”, the FTC accused POM of making false and unsubstantiated advertising claims that its products could prevent or treat heart disease, prostate cancer, and erectile dysfunction.
“Contrary to POM Wonderful’s advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses [heart disease, prostate cancer or erectile dysfunction],” said David Vladeck, director of the FTC’s Bureau of Consumer Protection.
If administrative law judge Michael Chappell affirms the FTC’s complaint, a proposed order would require pre-approval from the Food and Drug Administration (FDA) before POM is permitted to make future claims, said the FTC.
"Although FDA approval of health claims generally is not required for compliance with the FTC Act, the proposed order would require FDA pre-approval before POM Wonderful makes future claims that certain products prevent or treat serious diseases."
However, POM contends that the FTC has no legal right to require that it seek FDA approval before it makes claims.
Emord: FTC has overstepped the mark
Commenting on the case last year, food law attorney Jonathan Emord said that the FTC had overstepped the mark and “richly deserves to lose… If the FTC prevails, this case will establish a very speech restrictive precedent."
Writing about the case in the FDA Law blog this week, Hyman, Phelps & McNamara associate Riëtte van Laack and director John R. Fleder said this was the first time the issue of whether the FTC can require prior approval of claims from the FDA has been tested in court.
"Based on the record generated during the FTC trial, POM maintains that no cease and desist order is warranted.
"It also contends that for claims for foods and dietary supplements, the substantiation standard is not two randomized placebo controlled studies and that the FTC does not have the authority to require FDA approval before POM makes claims.
"We believe that this case will be the first time that the prior FDA approval issue has been litigated."