FDCA Express Preemption Victory in Benecol Misbranding Class Action

by Morrison & Foerster LLP - Class Dismissed

A recent Third Circuit case brings good news for defendants making express preemption arguments under the Food, Drug and Cosmetic Act (FDCA) in misbranding class actions. Last week, the court affirmed the dismissal of a putative class action holding that Johnson & Johnson’s representations of the trans fat content and cholesterol-lowering capabilities of its Benecol® products were expressly preempted by the FDCA, as amended by the Nutrition Labeling and Education Act (NLEA). Young v. Johnson & Johnson, Case No. 12-2475, slip op. (3d Cir. May 9, 2013).

Background and District Court Ruling
Johnson & Johnson (J&J) manufacturers Benecol® butter substitute products (Benecol). The labels for the products state that Benecol contains “NO TRANS FAT,” and the “Nutrition Facts” box notes the “Amount/Serving” of “Trans Fat” as “0g.” The labels also made claims about the products’ ability to lower cholesterol, such as “Proven to Reduce Cholesterol.”

The plaintiff filed suit against J&J, alleging that the trans fat and cholesterol statements were false and misleading because Benecol contained small amounts of trans fats, which could be detrimental to heart health. Plaintiff also claimed that he paid a premium for these products in reliance on the purported false and misleading claims. J&J filed a motion to dismiss the claims arguing that plaintiff lacked standing for failure to adequately plead an injury-in-fact and his claims were expressly preempted by the FDCA.  The District Court agreed and dismissed the case.

“NO TRANS FAT” Claim Preempted
Plaintiff argued on appeal that although FDA regulations authorize Benecol to claim “0g Trans Fat Per Serving,” the regulations do not expressly permit a claim of “NO TRANS FAT” for the product as a whole. The Third Circuit rejected this argument, noting that the “FDA has long recognized this potential for a discrepancy” and has issued regulations that “authorize nutrient content claims based on per serving amounts, even if those claims are not entirely accurate on a per product basis.” As such, plaintiff sought to impose state law requirements that were not identical to the FDCA, and his “NO TRANS FAT” claim was expressly preempted.

Cholesterol Claims Preempted
Plaintiff also contended on appeal that his claims were not preempted because he sought to impose state law requirements that were identical to federal regulations prohibiting false and misleading health claims. The Court of Appeals disagreed, holding that J&J was permitted to make heart health claims regarding Benecol based on the product’s plant stanol esters content because those claims are authorized by FDA regulations (21 C.F.R. §§ 101.14 and 101.83).

Plaintiff argued that the “Proven to Reduce Cholesterol” claim was false and misleading because this statement was expressed in reference to the product as a whole, which contains harmful trans fats, and not in reference to the product’s plant stanol esters content. The Court rejected this argument, noting that FDA regulations specifically authorize these cholesterol claims based solely on the product’s plant stanol ester content.

The Young decision is strong support for express preemption arguments under the FDCA, particularly for cases involving trans fat and other nutrient content and health claims. Even though the Third Circuit stated that the decision is “non-precedential,” it is nonetheless persuasive authority for how courts should analyze claims in similar cases.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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