The Third Circuit recently upheld the dismissal of a class action complaint against Johnson & Johnson (J&J) challenging the labeling of its Benecol Spreads bearing the statements “No Trans Fat” and “Proven to Reduce Cholesterol.” The plaintiff argued that these statements were false and misleading because Benecol contains trace amounts of trans fat, which the plaintiff alleged may be harmful to heart health.
A three-judge panel affirmed the district court’s ruling that the Nutrition Labeling and Education (NLEA) preempted the plaintiff’s claims. The NLEA expressly preempts state food-labeling requirements that are not identical to the requirements in the Food, Drug and Cosmetic Act and its implementing regulations. In this case, two federal regulations were directly on point and governed the statements regarding trans fat and cholesterol-lowering benefits.
FDA regulations require certain nutritional information on food packaging, including a statement of the number of grams of trans fat in a serving. The regulations further require where a serving contains less than 0.5 grams of trans fat, the content should be expressed as zero. The regulations deem these amounts to be “insignificant” for purposes of stating nutrition content. FDA regulations also allow statements of “no fat” and “no saturated fat” when a product contains less than 0.5 grams per serving, an insignificant amount. Relying on these regulations, the Third Circuit concluded that Benecol’s “No Trans Fat” claim is authorized by the NLEA. Because the plaintiff was seeking to enforce a requirement different from what the NLEA allows, the panel found his claims expressly preempted. This decision is in accord with the Ninth Circuit, which similarly held that a claim challenging a “No Trans Fat” statement was preempted when the amount of trans fat was required to be rounded to zero in the nutrition facts panel. Carrea v. Dreyer's Grand Ice Cream, Inc., 475 Fed. Appx. 113, 115 (9th Cir. 2012).
Cholesterol claims are also governed by FDA regulations. Specifically, the regulations provide for health claims “which summarize the relationship between diets that include plant sterol/stanol esters and the risk of [heart disease] and the significance of the relationship.” The regulations further identify a threshold amount of plant sterols that a product must contain in order to make such a health claim. Based on these regulations, the Third Circuit concluded that the cholesterol claims were authorized by statute, and thus the NLEA expressly preempted plaintiff’s attempt to bar those claims.
This decision, cited as Young v. Johnson & Johnson, No. 12-2475, 2013 WL 1911177 (3d Cir. May 9, 2013), has been designated non-precedential.