Big Time Vapes, Incorporated, et al. v. Food and Drug Administration, et al.

Congress enacted the Tobacco Control Act (TCA or “the Act”) in 2009, imposing a detailed regulatory framework initially limited to cigarettes and “smokeless tobacco” (essentially, snuff). But TCA § 387a(b) also gave the Secretary of Health and Human Services the unilateral power to extend the TCA’s reach to cover any other “tobacco product,” a capacious term capturing “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” The TCA does not require the Secretary to make any factual finding, consider any particular factors, or even hew to any broadly worded limiting principle in deciding whether to extend federal regulation over additional “tobacco products.” In 2016, the FDA employed this authority, “deeming” everything meeting the “tobacco product” definition to be subject to the TCA. In one fell swoop, the Agency extended the TCA’s requirements to everything Congress had declined to regulate in 2009 (like cigars, hookah, and pipe tobacco), as well as to any other existing and future “tobacco products,” including the vapor products of particular concern to Petitioners. The question presented is: Whether Petitioners have stated a claim that § 387a(b) grants excessive policymaking discretion to the executive branch to determine which tobacco products shall be federally regulated, impermissibly delegating legislative authority in violation of the separation of powers established by the Constitution.