By Riëtte van Laack –
On May 9, 2013, the U.S. Court of Appeals for the Third Circuit affirmed a District Court’s decision that a state law class action concerning claims regarding the absence of trans fat and cholesterol lowering effect was preempted.
The case, Young v. Johnson & Johnson (“J&J”), involved J&J’s Benecol Spreads. Plaintiff asserted various state law causes of action based on allegedly false and misleading labeling of Benecol. Specifically, plaintiff alleged that the claim that the product contained no trans fat was misleading because, although the amount of trans fat per serving was sufficiently low to require declaration as zero g per serving in the Nutrition Facts box, the products do contain a small amount trans fat. In addition, plaintiff alleged that the claim that Benecol spreads reduced cholesterol was false and misleading because the claim did not specify that the cholesterol reduction was due to the presence of plant stanol esters in the Benecol spreads, and the presence of trans fat in the spreads invalidated the claim.
Defendant argued that the claims were expressly preempted by the FDC Act § 403A(a) barring state nutritional labeling requirements that are not identical to the FDC Act and FDA’s implementing regulations.
The Court interpreted the preemption provision broadly. It held that although the FDA regulations did not expressly permit the claim “No Trans Fat,” the regulations do allow claims about the amount of a nutrient if it is not false and misleading. The Court reasoned that the claim “No Trans Fat” was not misleading because an amount of less than 0.5 g trans fat per serving must be identified as 0 g in the Nutrition Facts box, and because the regulations specifically allow a “no [nutrient]” claim for other nutrients (such as fat) if the product contains less than 0.5 g of the nutrient. The Court concluded that plaintiff was attempting to enforce a state law requirement that was not identical to the federal requirement.
Similarly, according to the Court, the cholesterol reduction claim for Benecol spreads appeared to comply with the applicable FDA regulations. In fact, the regulations specifically authorize a cholesterol reduction claim for foods containing stanols, and an insignificant amount of trans fat does not disqualify a product for the claim. Thus, plaintiff sought to impose a standard that is not identical to the standard set forth in FDA regulations and therefore plaintiff’s claim was expressly preempted.