On September 13, 2010, POM Wonderful LLC, the maker of POM juice products, filed suit in Federal Court in Washington against the FTC claiming that the FTC’s recently modified substantiation standard for advertising encroaches on the authority of the FDA, violates POM’s 1st and 5th Amendment rights of free speech and due process, and violates the FTC’s Administrative Procedures Act’s own rulemaking procedures. (Click here for the complaint)
We’ve previously blogged about the new substantiation requirements found in recent consent orders against Nestle U.S.A. and Iovate Health Sciences, Inc. POM alleges first that it has been told by the FTC that food and dietary supplement advertisers must now obtain FDA approval before making claims that a product treats, mitigates or prevents disease. This requirement applies irrespective of whether the claims are supported by competent, reliable evidence. Second, POM alleges that the FTC has told it that food and dietary supplement advertisers must have two well-controlled clinical studies for non-disease claims - a requirement that POM argues “represents a dramatic change in the level of substantiation required to establish the truth of these types of claims.”
POM’s Complaint asserts that the FTC has violated the First Amendment by imposing a “prior restraint” in the form of FDA preapproval on truthful speech. POM also alleges a violation of the Fifth Amendment in that
“to its detriment, [it] has relied on the FTC’s long standing policies and rules that used a ‘substantiation’ standard to evaluate advertising and speech. POM invested tens of millions of dollars in establishing a research program to better understand and promote the nutritional qualities and health benefits of pomegranates. The new FTC rules essentially bar POM from discussing or disclosing the results of its research and the benefits of its products.”
POM claims that the rules effectively cut off its speech about its research and deprive it the value of its research as property.
POM has requested a declaration that the FTC’s new standard is invalid and that the agency has overstepped its authority, improperly restrained POM’s 1st and 5th amendment, and improperly usurped the power of the FDA.