Affirming a victory for Nestle, Gerber, and The Dannon Company, the Fourth U.S. Circuit Court of Appeals agreed with a federal district court judge that a challenge to the companies’ labels was preempted by federal law.

Michelle Nemphos filed a putative class action alleging that the defendants violated Maryland state law by deceptively advertising their products as beneficial to children and in failing to warn purchasers about the risks of dental fluorosis for children who consume large amounts of fluoride. Her use of the defendants’ bottled water, infant formula, and baby food for her daughter resulted in dental fluorosis, or damage to her baby’s tooth enamel, she said.

A federal court judge granted the defendants’ motion to dismiss the suit based on federal preemption grounds. Nemphos appealed.

The Nutrition Labeling and Education Act, which fortifies the Food, Drug, and Cosmetic Act, prohibits states from disrupting national uniformity by prohibiting non-identical requirements, the Fourth Circuit said. Specifically, 21 U.S.C. Section 343-1(a)(1) forbids states from establishing any requirement that is “not identical to” the federal requirements in specific areas of food labeling, including federal standards of identity.

Pursuant to the standard of identity for water, fluoride is classified as an optional ingredient. Manufacturers may add fluoride within the limitations set forth in the regs, the panel explained, and must only add a statement to its label if the level of fluoride surpasses the specified maximum concentration. In addition, the Food and Drug Administration, when promulgating the regs, considered – and rejected – a required warning about the risks of dental fluorosis.

“Federal law already covers the ground that Nemphos aims to unsettle through her claims. She seeks a required warning that is additional to and certainly ‘not identical to’ the federal standard,” the court said, reiterating the value of “a nationally uniform regulatory system, rather than a fifty-state patchwork.”

“To allow a nonidentical state requirement to contravene the Food and Drug Administration’s approach in this area would undermine the NLEA’s preemption framework,” the court wrote. “Without this system of preemption, a manufacturer might be whipsawed by federal regulations delineating permissible labeling and state law claims of impermissibility.”

The three-judge panel also rejected Nemphos’ attempt to distinguish the standard of identity labeling regulation from other forms of advertising and marketing. The NLEA’s preemption provision “makes no exception for marketing or advertising in areas regulated by the FDA,” the court said.

Carving out such an exception “when the FDA has already made an explicit determination about fluoride-related labeling, would be not only inconsistent but also potentially confusing,” and would undermine the NLEA’s preemption framework, the panel added.

The Fourth Circuit affirmed dismissal of the plaintiff’s complaint with prejudice, noting that any amendment of her claims “would be futile.”

To read the opinion in Nemphos v. Nestle, click here.

Why it matters: In its opinion upholding dismissal based on preemption, the federal appellate panel emphasized that the uniform labeling system provided by the FDCA and the NLEA benefits the manufacturer and the consumer. “Manufacturers can produce and market foods consistently and cost-effectively across the United States,” the court wrote. “Consumers gain a reliable and comprehensible means of ascertaining the nutritional content of the foods they buy, wherever they may live or travel in this country. Armed with such information, consumers can make well-informed decisions about the types and quantities of ingredients in their diets.”

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