Antitrust Law Daily Wrap Up, STATE UNFAIR TRADE PRACTICES—D. Md.: Fluoride level statements for baby food, formula not deceptive, (Aug 22, 2013)

By Jody Coultas, J.D.

Nestlé USA, Inc., Gerber Products Company, Inc., and The Dannon Company, Inc. were entitled to dismissal of a consumer’s Maryland Consumer Protection Act (CPA) claims based on statements made concerning the fluoride levels of their products, the federal district court in Baltimore has held (Nemphos v. Nestlé USA, Inc., August 21, 2013, Russell, G.).

The complaining consumer alleged that the companies’ products—including bottled water with added fluoride, baby food, and infant formula—exposed her daughter to excessive amounts of fluoride and caused aesthetic damage to her teeth, without warning of the risk of harm such as dental fluorosis. The companies argued that the claims were preempted by the Food, Drug, and Cosmetics Act (FDCA) and Food and Drug Administration (FDA) regulations.

To determine whether state law claims are preempted, the court looks at whether the food upon which the plaintiffs sought to impose a duty was one subject to a standard of identity under the FDCA, and whether the duty sought was identical to the FDCA labeling requirements.

Because the purchaser’s claims would impose requirements that were inconsistent with FDA regulations, the court held that the claims were preempted. The companies argued that the claims were preempted because they were based on common law duties that would require the companies’ products to contain less fluoride than the FDA allows or bear a warning that the FDA does not require. The purchaser countered that she only sought damages for her daughter’s injuries and not to impose state requirements different from FDA regulations.

The FDCA expressly preempts state food and bottled water labeling requirements that are non-identical to its own requirements. Bottled water and baby food are regulated by the FDA, as is the addition of fluoride to food and water. Federal law does not require products containing no added fluoride to bear information concerning dental fluorosis. Thus, the products were subject to a standard of identity under the FDCA and the purchaser sought to impose non-identical requirements. The fact that the purchaser sought damages, rather than a warning label, was not an issue because the claims would nevertheless create a state requirement precisely prohibited by the FDCA.

The companies also argued that the purchaser was preempted from using state tort law to require a health claim linking fluoride in the products to dental fluorosis. The FDA has consistently characterized dental fluorosis as a “significant adverse aesthetic effect[],” rather than a condition affecting the health or functionality of teeth. Because the FDA considers dental fluorosis to be an aesthetic effect, it would not be a health claim to link fluoride to dental fluorosis, and any obligation to do so falls outside the health claim preemption of the FDCA, according to the court.

The purchaser’s argument that the claims were permissible through the Nutrition Labeling and Education Act’s safety concern preemption exception was dismissed by the court because the use of fluoride in the products did not implicate a safety concern. The FDA has found that fluoride is safe to include in bottled water, and in products containing fluoridated public water as an ingredient, if manufacturers abide by FDA regulations. The purchaser never argued that the companies failed to abide by FDA regulations and the FDA does not consider dental fluorosis to be a health issue.

Even if the CPA claim were not preempted, the court would have dismissed the claim for failure to meet the heightened pleading requirement of Federal Rule of Civil Procedure 9(b). The purchaser argued that Nestlé and stated that their fluoridated bottled water was designed for children, but did not allege when the disclosure was made, how it was communicated, how it became known, or how it had been relied upon. Conclusory statements cannot satisfy Rule 9(b).

The case is No. GLR-12-2718.

Attorneys: Christopher T. Nace (Paulson and Nace PLLC) for Michelle Nemphos. Lauren Schultz Colton (Hogan Lovells) for Nestlé USA, Inc.

Companies: Nestlé USA, Inc.; Gerber Products Co., Inc.; Dannon Co., Inc.

Cases: StateUnfairTradePractices MarylandNews