Please Pass the Prune Juice: Must FTC Toe FDA’s Line on Health Claims?

May 25, 2011

By Riëtte van Laack & Ricardo Carvajal

As we reported on several occasions (see, and here), recent Federal Trade Commission ("FTC") consent orders concerning health-related claims include the requirements that 1) certain claims be approved by FDA under the Nutrition Labeling and Education Act of 1990 ("NLEA") and 2) certain other claims be supported by two well-designed clinical studies to ensure that the claims are adequately substantiated.  Last year, POM Wonderful LLC ("POM") sued FTC claiming that these additional requirements exceeded FTC’s authority and constitute a violation of an advertiser’s First Amendment rights.  FTC promptly followed up with its own complaint against POM.  

Recently, the Alliance for Natural Health USA, Durk Pearson and Sandy Shaw (“Petitioners”) petitioned FTC essentially making the same arguments as POM and asking FTC for rulemaking to eliminate from its consent orders the requirements described above, which the petition characterizes as the “FDA Prior Restraint Requirement” and the “FTC Two Clinical Trial Requirement.”    Petitioners further ask FTC to implement the constitutional mandate that a federal agency refrain from imposing limits on future speech if the agency can identify a qualification for a claim that prevents deception.

Petitioners claim that they would like to market a prune juice product with a claim that it helps “relieve chronic constipation.”  Petitioners do not possess two well-designed clinical trials substantiating this claim and FDA has not approved the claim.  Petitioners assert that the requirements in the FTC consent orders constitute a rule within the meaning of the Administrative Procedure Act that prevents Petitioners from communicating truthful and not misleading information about the health benefits of their product.   

As explained by Petitioners, it has been firmly established by Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) and its progeny (cases litigated by Petitioners) that the First Amendment protects the right of a party to make a truthful and not misleading claim that characterizes the relationship of a nutrient to a disease – even where that claim is supported by evidence that falls short of significant scientific agreement.  Petitioners argue that the holdings of these cases are equally applicable to FTC’s consent orders.  Petitioners assert that the federal government must allow nutrient-disease risk reduction claims backed by credible but inconclusive evidence to enter the market place, and rely on claim qualification as a less restrictive alternative to prohibition.  Further, the burden is on the government to prove (with empirical evidence) that no claim qualification will eliminate the allegedly misleading aspects of the claim. 

The petition raises questions concerning the constitutionality of FTC’s recent consent decrees and FTC’s approach to substantiation of health-related claims.  FTC’s guidance documents maintain that there is no fixed substantiation standard for such claims.  Yet the consent orders and FTC employees’ statements suggest that there is such a standard, namely at least two adequate and well-controlled human clinical studies – with no provision for the use of disclaimers.  The petition, however, is silent on the limits of constitutional protection when it comes to claims that a product treats (as opposed to reduces the risk of) disease.  Absent drug approval, FDA considers such claims unlawful and not entitled to constitutional protection – and the courts have agreed.  One thing is certain: where and how FTC draws the line between adequate and inadequate substantiation will continue to be a hot topic in 2011.