Antitrust Law Daily Wrap Up, ADVERTISING—3rdCir: Trans Fat and Cholesterol Labeling Is Subject to Federal Law, (May 10, 2013)

By Jody Coultas, J.D.

Johnson & Johnson (J&J) was not liable under the New York and New Jersey consumer protection laws for mislabeling its Benecol products, since the state law claims were preempted by federal law, according to the U.S. Court of Appeals in Philadelphia (Young v. Johnson & Johnson, May 9, 2013, Jordan, K.).

J&J manufactures Benecol® Regular Spread and Benecol® Light Spread butter/margarine substitutes, which were labeled as containing "No Trans Fats" and as "Proven to Reduce Cholesterol." The purchaser alleged that the trans fat content labeling and touted cholesterol-lowering capability were false and misleading because Benecol contained small amounts of trans fats.

A trial court dismissed the New Jersey and New York consumer protection law claims for lack of standing and held that the claims were preempted by the Food, Drug and Cosmetic Act (FDCA), as amended by the Nutrition Labeling and Education Act (NLEA).

The purchasers state law claims concerning the trans fat claims were preempted by the NLEA because the proposed state law requirements were not identical to the federal requirements, according to the court. The purchaser argued that he sought to prohibit false and misleading nutrient content claims regarding trans fat content per product, which was not inconsistent with the FDA’s regulation allowing nutrient content claims about trans fat per serving.

Although the FDA does not specifically say a product can advertise itself as containing "NO TRANS FAT" when it has an insignificant amount, the agency does allow claims that a product contains "no fat" or "no saturated fat," without reference to a per-serving limitation, provided that the product indeed contains less than 0.5 grams per serving. Benecol contained less than 0.5 grams of trans fat per serving, and therefore properly disclosed that it contains "0g of trans fat" per serving in the Nutrition Facts box. The nutrient content claim regulations promulgated under the NLEA authorized the trans fat claims, based on the per serving amount of trans fats that the product contained

The court held that the cholesterol claims were also preempted because the proposed requirements were not identical to the NLEA requirements. The purchaser argued that the FDCA did not preempt the cholesterol claims because he sought to enforce state law requirements that were identical to regulations prohibiting false and misleading health claims. J&J’s "Proven to Reduce Cholesterol" claim was a "health claim" subject to the FDCA because it was based on the fact that the product included particular amounts of plant stanol esters, and therefore characterized the relationship of a substance to a disease or health-related condition. The claims, therefore, were not false or misleading.

The case is No. 12-2475.

Attorneys: Jared H. Beck (Beck & Lee) for Thomas Young. Jeffrey J. Greenbaum (Sills, Cummis & Gross) for Johnson & Johnson.

Companies: Johnson & Johnson

Cases: Advertising StateUnfairTradePractices DelawareNews NewJerseyNews PennsylvaniaNews