The hearing, presided over by administrative law judge Michael Chappell, was called after the FTC accused POM of making unsubstantiated claims about its juices and supplements, and will be keenly followed by the food/supplements and legal professions alike.
Food law attorney Jonathan Emord said: "The FTC richly deserves to lose. By presuming to enforce the NLEA [Nutrition Labeling and Education Act] prior restraint on health claims, it has exceeded the limits of its statutory authority.
"By presuming to enforce that prior restraint without abiding by the constitutional mandate of Pearson v. Shalala [1999 case that validated qualified health claim messaging as a First Amendment freedom of speech right] it has doubly erred."
Emord: Speech restrictive precedent
Regardless of how Chappell rules, the losing party would appeal and, thereafter, the case could proceed to federal court, predicted Emord.
"If the FTC prevails", he added, "this case will establish a very speech restrictive precedent." In the Pearson v. Shalala case, he said, the DC Circuit held that even if the Food and Drug Administration (FDA) refuses to approve a claim under the NLEA health claims review process, it must allow the claim to enter the market (with qualifications) unless it can prove there is no qualifying statement "capable of eliminating misleadingness".
Deplorable move
He added: "FTC’s [proposed] order [if its complaint is affirmed] would compel a party to obtain NLEA health claims approval as a proxy for an FTC deceptive advertising determination without complying with Pearson v. Shalala.
"While FDA is forbidden from banning claims it does not approve by Pearson v. Shalala, the FTC seeks to do what FDA constitutionally cannot: demand NLEA health claims approval without complying with Pearson v. Shalala’s less speech restrictive requirement of a claim qualification.
"That is an end-run around the Constitution and a deplorable move by FTC. The FTC is presuming to apply FDA standards not applicable to advertising. FTC says that it is doing so as a 'proxy' for its own deceptive advertising review, but that is a leap of faith, beyond the limits of its statutory authority."
‘Completely unwarranted’
In its complaint, which POM has dismissed as “completely unwarranted”, the FTC accused POM of making deceptive disease prevention and treatment claims in ads in high-profile publications including The New York Times along with its own websites.
“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.
Pre-approval needed for claims?
If Chappell affirms the FTC’s complaint, a proposed order would require the unusual step of pre-approval from the FDA before the company is permitted to make future claims, said FTC spokeswoman Betsy Lordan. The hearing could last several weeks, after which the judge will make an initial decision, she said."It will run for the rest of the week, adjourn, then start again in late July and finish sometime in August.
"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."
POM is currently embroiled in a complex web of litigation, having itself launched legal action against the FTC alleging it had exceeded its statutory authority by establishing a two-clinical trial standard to back claims.
It has also filed actions against Coca-Cola Minute Maid, PepsiCo Tropicana and Ocean Spray alleging misleading claims about the contents of their pomegranate-containing juice products.
Separately, POM is itself accused of misleading consumers in a class action lodged in a Florida state court.