Federal Preemption Upheld in Case Involving Labeling of Bottled WaterJanuary 11, 2009
By Ricardo Carvajal & Colleen M. Brown –
Purified water is at the heart of a recently decided case in which the Federal Food, Drug, and Cosmetic Act ("FDC Act") was found to expressly preempt state law claims alleging unfair and deceptive trade practices in violation of state consumer protection laws. Plaintiffs in the case, In re: PepsiCo, Inc. Bottled Water Marketing and Sales Pratices Litigation (MDL No. 1903), sued PepsiCo for fraudulently marketing Aquafina based on label graphics and statements that allegedly give the false impression that the water is from a mountain source when it is sourced from public drinking supplies. PepsiCo filed a motion to dismiss, in part on the grounds that the claims are expressly preempted by section 403A of the FDC Act.
Aquafina’s label depicts a mountain range and a rising or setting sun. The label also includes the phrases “Pure Water – Perfect Taste” and “Purified Drinking Water.” The back of the label includes the statement “BOTTLED AT THE SOURCE P.W.S.” In 2007, PepsiCo disclosed that the water used in Aquafina is public drinking water (tap water) that has been purified, but did not change the Aquafina label to explicitly say so. Plaintiffs contended that PepsiCo should disclose the source of Aquafina in its labeling.
Under the authority of section 401 of the FDC Act, FDA has established standards of identity for various types of water, including “purified water.” (See 21 CFR 165.110(a).) Section 403A of the FDC Act states that no state or subdivision of a state may directly or indirectly establish “any requirement for a food which is the subject of a standard of identity established under section 401 that is not identical to such standard of identity. . ..” 21 U.S.C. sec. 343-1(a)(1). Thus, the key question presented in this case was whether “the duties imposed by Plaintiff’s state law claims are ‘identical’ to those imposed by the standard of identity for purified drinking water.”
The federal standard of identity for bottled water from a “community water system” provides that such water must be labeled as “from a community water system” or “from a municipal source,” but explicitly exempts water that meets the definition of purified drinking water from this disclosure requirement. 21 CFR 165.100(a)(3)(ii). Notwithstanding this exemption, plaintiffs argued that PepsiCo could be held liable under state law for failing to disclose the source of Aquafina because of the misrepresentations as to source made on its label. The court drew on preambles to the 1993 proposed rule and the 1995 final rule establishing the standard of identity to find that FDA “specifically addressed the disclosure of source information and determined, in its expert opinion, that representations of source are immaterial in the context of purified water.” The court concluded that plaintiffs’ claims “are expressly preempted. . . because: (1) federal law is not silent on the subject of implied labeling misrepresentation regarding the municipal source of bottled water, and (2) given that the Aquafina fits within the exception for purified water and thus complies with the FDCA’s requirement, Plaintiff’s state law claims by necessity are premised on requirements that are not parallel to those imposed by federal law.” In its decision, the court drew on the Supreme Court’s prior holdings in Bates v. Dow Agroscience LLC, Medtronic, Inc. v. Lohr, and Riegel v. Medtronic, Inc.