Last Tuesday, FDA published in the Federal Register the final version of its “Deeming Regulation.” The final rule, like the proposed rule, subjects all tobacco products to FDA regulation. Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), a “tobacco product” is “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” The final Deeming Regulations gives FDA control over previously unregulated products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, hookah tobacco, and gels. FDA’s proposed rule had provided an option that would have exempted premium cigars from regulation, but FDA’s final rule adopted the broader option, subjecting all cigars to FDA regulation.
The 499-page rule responded to a number of challenges posed to FDA’s regulation of previously unregulated tobacco products. Many of these challenges were directed at e-cigarettes (“electronic nicotine delivery systems,” or “ENDS”). FDA responded to these challenges by articulating its view of its authority to regulate ENDS. Specifically, FDA believes:
E-cigarette regulation will benefit the public health, though it is unclear whether e-cigarettes benefit the public health
FDA’s authority to regulate ENDS does not require the agency to establish that regulating ENDS will benefit the public health. The ENDS industry had argued that FDA was required to quantify the health risks of certain products before subjecting them to regulation. FDA argued that section 901, which gives FDA authority to deem products, did not have a public health standard.
FDA also argued even if there were a public health standard, “regulating ENDS will still benefit public health” even if it’s not clear whether ENDS benefits public health. Deeming ENDS as tobacco products will provide FDA with information regarding the health risks of ENDS ingredients, ensure product consistency, and allow FDA to require new studies on the public health impacts of ENDS products.
FDA will not broadly exempt e-cigarettes from its restrictions on tobacco advertising.
The deeming regulations imposed the same restrictions on advertisement of ENDS products as on combustible tobacco products. FDA banned ENDS retailers from distributing free samples of all products to “eliminate a pathway for youth to access to tobacco products.” FDA also refused to exempt ENDS manufacturers from regulations prohibiting manufacturers from using the terms “smokeless” and “smoke-free” to describe combustible tobacco products. Until FDA “obtains product-specific evidence,” the agency would evaluate an ENDS manufacturer’s use of “smokeless” or “smoke-free” on a case-by-case basis.
Some commenters argued that FDA’s restrictions on advertising of combustible tobacco products would unconstitutionally violate the First Amendment if applied to ENDS products. For example, commenters had suggested that FDA’s restrictions on distributing free samples for newly deemed products was unconstitutional because “FDA has presented no evidence that samples of these products lead to youth initiation” and therefore, the government would not be advancing a legitimate government interest. Whether FDA’s restrictions on ENDS advertising are constitutional may depend on whether a court finds that the government has substantial interests in limiting ENDS advertising. In Discount Tobacco City & Lottery v. U.S., the Sixth Circuit held that the government’s ban on product sampling for previously regulated tobacco products was justified because the government had “presented overwhelming evidence” of the harms that result when youth initiate and use previously regulated tobacco products. The government’s interest in protecting youths from ENDS products may be less substantial where it is unclear whether ENDS are harmful and whether ENDS would result in “a transition to combusted tobacco products.”
ENDS manufacturers will have three years to undergo pre-market review.
On August 8, 2016, all ENDS manufacturers will need to abide by FDA’s premarket authorization requirements. FDA has three pathways for market authorization of tobacco products: premarket tobacco product applications (PMTA), substantial equivalence (SE), and exemption from SE. The PMTA pathway is the most onerous pathway and requires an applicant to demonstrate that a new tobacco product would “be appropriate for the protection of the public health.” Tobacco products introduced on the market before February 15, 2007 will not need premarket approval.
Because there are possibly no valid predicates for ENDS products marketed before February 15, 2007, all ENDS products may need to submit a PMTA to continue to market their products. FDA finalized a timeline to fully implement its regulations. FDA will not enforce premarket requirements for ENDS products until August 8, 2018. Between August 8, 2018 and August 8, 2019, FDA will not initiate enforcement action for ENDS products with a submitted marketing application. After August 8, 2018, all tobacco products on the market will need FDA approval to remain on the market.
FDA gave ENDS manufacturers two years to conduct and submit product analyses, nonclinical, and clinical analyses to support an ENDS product’s impact on the public health. FDA published draft guidance on PMTA applications for ENDS on the same day the agency finalized its Deeming Regulations. The draft guidance suggested that applicants may need to “conduct certain [nonclinical and clinical] investigations themselves” to support their PMTAs. It is unclear whether the Deeming Regulation provides enough time for manufacturers to conduct the type of large-scale epidemiological studies that could assess the public health risks of their ENDS product.
ENDS manufacturers will likely challenge FDA’s deeming regulations before and after the rules go into effect. On May 10, Nicopure became the first ENDS manufacturer to challenge FDA’s Deeming Regulation, arguing that the rule exceeds FDA’s authority and is contrary to the First Amendment. FDA’s regulation of ENDS will likely remain contentious especially especially as the public health effects of ENDS remain unclear.