Trial News

A federal court has ordered the FDA to require manufacturers of electronic nicotine delivery systems (ENDS), including e-cigarettes, to submit premarket applications demonstrating their products are adequately labeled and manufactured by May 2020, shortening the agency’s intended deadline by two years. (Am. Acad. of Pediatrics v. Food & Drug Admin., 2019 WL 3067492 (D. Md. July 12, 2019).) Multiple states and localities already have restricted the sale of flavored tobacco products and indoor vaping, adopted e-cigarette taxes, and moved to limit sale of tobacco products to minors. The most drastic laws, adopted by San Francisco’s Board of Supervisors in late June, ban the sale and distribution of e-cigarettes entirely. (Ordinance 121-19 and Ordinance 122-19).

The FDA has been slow to regulate e-cigarettes—in 2016, it finally adopted a rule deeming all ENDS, including e-cigarettes, to be “tobacco products.” This final rule allowed the agency to restrict e-cigarette sales and to require premarket product review to ensure e-cigarettes are appropriately protective of public health. Though an e-cigarette manufacturer and several organizations challenged this “deeming rule” and the FDA’s authority to regulate ENDS, a federal district court upheld the rule in 2017, as Trial News previously reported.  

Despite its new authority, the FDA (through guidance) deferred enforcement of ENDS premarket review requirements through 2022. But the agency came under fire for allowing flavored e-cigarettes—which are of particular appeal to young people—to remain unrestricted. It backtracked in March, announcing its intent to prioritize enforcement of flavored products and move the premarket application deadline up to 2021 for these products.

Maryland federal district court Judge Paul Grimm found that this adjusted deadline was still insufficient, and the court ordered the FDA to require manufacturers of new tobacco products, including ENDS, to file marketing applications by May 2020. Judge Grimm had previously ruled that the FDA’s decision to defer enforcement of premarket review requirements until 2022 violated the Administrative Procedure Act’s notice and comment requirements. (Am. Acad. of Pediatrics v. Food & Drug Admin., 2019 WL 2123397 (D. Md. May 15, 2019).) The court held that the earlier deadline is necessary in light of “uncertainty in the efficacy of e-cigarettes as smoking cessation devices, . . . the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency.” He also noted that manufacturers have “overstated effects that a shorter deadline may have.”

In arguing for an extended deadline, manufacturers alleged that they required further formal guidance from the FDA before filing product applications. But late last month, the agency finalized guidance for manufacturers submitting these applications. The guidance clarifies what information applications should include to demonstrate a product’s marketing will be “appropriate for the protection of public health” and recommends that applications address nicotine exposure and addictiveness product label warnings, provide for the use of child-resistant and exposure-limiting packaging, include toxicological testing outcomes, and list ingredients and components along with a description of their intended functions. The guidance also clarifies that any ENDS products marketed for “tobacco cessation or for any other therapeutic purpose” must be approved as a drug or device, rather than as a tobacco product.

Lawrenceville, N.J., attorney Domenic Sanginiti, who handles e-cigarette products liability cases, said that the FDA “missed the opportunity to get in front of this issue much earlier—it's been aware of the problem for years but only now will oversee these products. Due to FDA inaction, many young people have become addicted to nicotine though the use of electronic nicotine delivery systems.” He added that “the narrative of these e-cigarette manufacturers is that their products are a safer alternative for tobacco users, but the amount of nicotine consumed by the average e-cigarette user likely far exceeds that used by a traditional tobacco product user.”

Meanwhile, multiple states and localities, frustrated with the FDA’s delays, have already taken action to limit access to ENDS by restricting sales of e-cigarette products, especially flavored products that are attractive to young people; prohibiting vaping indoors; and adopting e-cigarette taxes. In late June, San Francisco’s Board of Supervisors banned the sale and distribution of e-cigarettes entirely. The city adopted Ordinance 122-19, which prohibits the sale and distribution of e-cigarettes subject to FDA premarket review requirements that do not have a premarket review order from the agency. In a second ordinance, 121-19, the city prohibited the sale, manufacture, and distribution of all tobacco products on city property.

Personal injury attorney Annesley DeGaris, of Birmingham, Ala., said “the fact that we have an epidemic of underage users addicted to nicotine is a big problem for e-cigarette manufacturers.” He added that while “there isn’t a quick and easy fix,” the San Francisco ban is “just the beginning” and state and local governments “will be increasingly proactive in their efforts to limit youth access to e-cigarettes.”

Christopher Stoy, a personal injury attorney in Fort Worth, Texas, lamented that “we’ve let people, including youth, use e-cigarettes for years but we haven’t taken the time to research their health impacts. It’s a mischaracterization to say that e-cigarettes are a safer alternative” to traditional tobacco products, he added, noting that “it’ll be 10 to 15 years before we know the true health impacts.”