Suit Targeting Benecol Dismissed on Preemption Grounds

September 25, 2012

By Ricardo Carvajal

A federal district court dismissed a class action that took issue with a number of allegedly false and misleading claims made on the label of Benecol, a butter/margarine alternative.  The claims at issue include “each serving contains .85g of plant stanol esters,” “proven to reduce cholesterol,” and “no trans fat.” 

Plaintiff contended that the amount of plant stanol esters in the product is insufficient, given that FDA’s health claim regulation for plant sterol/stanol esters and cholesterol requires that a food contain at least 1.7g of plant stanol esters to be eligible for the claim.  However, the court noted that FDA  issued a letter in 2003 permitting use of the claim in relation to products that contain lesser amounts of phytosterols (at least 400 mg per serving), and that FDA had engaged in rulemaking to amend the regulation.   The court observed that “Federal agency action short of formal notice and comment rulemaking can preempt state law.”  Based in part on the compliance of Benecol’s claim with FDA’s 2003 letter, the court found in favor of preemption.

Plaintiff also challenged defendant’s cholesterol-lowering claim on the ground that there were no studies supporting a conclusion that Benecol “as formulated” had the claimed effect.  The court noted that the health claim regulation does not require evidence that products have the claimed effect “as formulated.”  Rather, the regulation establishes “the minimum amount of plant stanol esters that a product must contain” to be eligible for the health claim.  Because plaintiff attempted to impose a requirement different from that imposed under federal law, the court again found in favor of preemption.

Finally, the court found plaintiff’s challenge to defendant’s “no trans fat” claim preempted because “FDA regulations explicitly define the term ‘0 Grams of Trans Fat’” to include levels of less than 0.5 g per serving.  The court concluded that drawing a distinction between “0 grams of trans fat” and “no trans fat” was unreasonable, that the terms were “functionally equivalent,” and that no consumer confusion would result from the use of both claims on the same package.