Contributed by Elizabeth Boggia
As many readers are aware, this past Spring the FDA issued a Final Rule concluding that e-cigarettes are deemed “tobacco products” and thus fall under the FDA’s authority to regulate. Earlier this month, the Central District of California determined that all but one state claim brought by consumers seeking stricter labeling and warnings were preempted by FDA guidance on labeling e-cigarettes. In re Fontem US, Inc., 2016 WL 6520142 (C.D. Cal. Nov. 1, 2016).
A group of consumers from California, Illinois, and New York sued companies, including Lorillard Tobacco Co., Reynolds American Inc., and Fontem US Inc., who make and market e-cigarettes under the brand name BLU. The consumers claimed that the defendants violated state laws by warning users only of the dangers of nicotine and failing to warn about the presence of chemicals such as formaldehyde and the risks users incur by taking deeper breaths when smoking e-cigarettes.
The defendants argued that by deeming e-cigarettes a tobacco product, the FDA made e-cigarettes subject to the Family Smoking Prevention and Tobacco Control Act (“TCA”) provision regarding the preemption of state requirements pertaining to tobacco products. The preemption provision states:
No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified tobacco products. 21 U.S.C. § 387p(a)(2)(A).
The defendants argued that state laws cannot require stricter labeling requirements for e-cigarettes than what the agency has proffered.
The plaintiffs contended that the analyses of similar preemption provisions by other controlling authorities mandate a conclusion that the TCA and the Final Rule do not preempt state warning requirements.
Ultimately, the Court found that the preemption analysis was straightforward. The FDA, pursuant to the authority it possesses under the TCA, has promulgated a labeling requirement that applies to e-cigarettes. Therefore, state labeling requirements that apply to e-cigarettes that are “different from, or in addition to” the FDA’s requirement are preempted.
The FDA specified a scripted statement mandating that the package label specify that the tobacco product contains nicotine and that nicotine is addictive. It mandated particular language, size, font, and visibility requirements for the warning label. The court reasoned that these facts make the warning requirement a far more specific mandate compared to those where requirements were found not to be preemptive in other instances.
The Court did allow a claim brought under California’s unfair competition law to continue. That law prohibits businesses from knowingly exposing consumers to hazardous chemicals such as formaldehyde without providing a clear warning, because the warning requirements of the statute do not necessarily constitute additional labeling that would be preempted by federal regulations.
The plaintiffs recently sought reconsideration of the ruling. We will continue to monitor this case and provide an update on future developments.