Tort/Negligence — Parent’s Fluoride Water Complaints Preempted

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Nemphos v. Nestle Waters NA Inc. (Lawyers Weekly No. 15-01-0068, 30 pp.) (Wilkinson, J.) No. 13-2146, Jan. 8, 2015; USDC at Baltimore, Md. (Russell, J.) 4^th Cir.

Holding: Federal law preempts a parent’s state-law claims against manufacturers of bottled water, infant formula and baby food plaintiff’s minor daughter consumed before developing dental fluorosis, allegedly from excessive consumption of fluoride in defendants’ products, and the 4^th Circuit upholds dismissal of plaintiff’s complaint for failure to state a claim.

Dental fluorosis results when young children ingest excessive fluoride over an extended period of time while their adult teeth are still developing below the surface of their gums. To address that risk, federal agencies such as the Food and Drug Administration issue recommendations and regulations for safe water fluoridation levels. The products at issue here are not alleged to have violated federal fluoride requirements. All of plaintiff’s claims are based on Maryland law, but she sued in federal court because the parties are citizens of different states.

The district court concluded federal law preempted plaintiff’s state-law claims. The manufacturers’ products were already subject either to a federal “standard of identity” or to other federal labeling regulations. Granting the relief requested by plaintiff would have required appellees’ products to have fluoride levels below the Food & Drug Administration’s established limits or to bear warnings not mandated by the FDA, the district court found.

The Federal Nutrition Labeling and Education Act of 1990 includes a series of express preemption provisions. These provisions – under the heading “National uniform nutrition labeling” – forbid states from establishing any requirement that is “not identical to” the federal requirements in five areas of food labeling. One of those areas, and the one at issue in plaintiff’s bottled water claims, concerns the “standard of identity.” Although the NLEA’s preemption provisions sweep broadly, state-law duties may be insulated from the Act’s preemptive reach if they involve warnings about food “safety.”

The FDA regulates bottled water as a food and has promulgated a standard of identity for it. The parties do not dispute the FDA’s capacity to regulate bottled water in this way – they disagree whether plaintiff’s state-law claims about fluoridated bottled water are preempted.

The FDA has set a range of permissible fluoride levels for bottled waters. Manufacturers may optionally add fluoride to bottled water so long as the concentration does not exceed the levels stipulated by the FDA. If those regulatory ceilings are breached, the manufacturer must place a warning on the label stating “Contains Excessive Fluoride” or “Contains Excessive Chemical Substances.”

The FDA requires no particular warning regarding dental fluorosis. But for a food such as bottled water that is the subject of a “standard of identity,” the NLEA preempts any state “requirement” that is not identical to the federal standard. However plaintiff frames her failure-to-warn claim, granting her relief would impose a requirement in the form of a warning under Maryland law. Plaintiff’s proposed “requirement” would not be “identical” to the FDA’s standard of identity. Her failure-to-warn claim is preempted.

Plaintiff’s claim that defendants misleadingly marketed and advertised their fluoridated bottled water as especially beneficial to children is essentially the same as her failure-to-warn claim, and it fails for the same reason. It would impose a requirement under state law that diverges from the federal warnings about the risks of dental fluorosis for their products in Maryland, even though the FDA resolved not to take that same step. The labeling requirements in the FDA’s standard of identity for bottled water already address fluoride content. To allow a non-identical state requirement to contravene the FDA’s approach in this area would undermine the NLEA’s preemption framework. The misleading marketing claim is preempted.

Plaintiff also requests relief based on defendants’ labeling of their infant formula and baby food products, which did not provide a warning about the risks of dental fluorosis. She has filed three versions of her complaint and even her latest amended complaint still falls short of stating a plausible failure-to-warn or misleading-marketing claim under federal pleading standards. The district court did not abuse its discretion in dismissing her third amended complaint with prejudice.