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. Read More