Big Time Vapes, Incorporated v. FDA, 963 F.3d 436

Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009 to give FDA authority to regulate tobacco products, with stated purposes emphasizing protection of public health and preventing youth access and addiction.
The TCA automatically covered cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, and delegated to the HHS Secretary (and thence FDA) authority to “deem” other products to be ‘‘tobacco products’’ subject to the Act.
In 2016 the FDA issued the Deeming Rule bringing Electronic Nicotine Delivery Systems (ENDS) and e-liquids within the TCA, triggering reporting, registration, and premarket-authorization (PMTA) requirements for many ENDS products.
Big Time Vapes and the United States Vaping Association sued, arguing section 901’s delegation to the Secretary violated the constitutional nondelegation doctrine; they sought declaratory and injunctive relief and a preliminary injunction.
The district court dismissed under Rule 12(b)(6), holding Congress supplied an intelligible principle (protecting public health and preventing youth access) and constrained the Secretary via the statutory definition of “tobacco product” and substantive regulatory rules; this appeal followed.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether §901’s delegation violates the nondelegation doctrine	§901 gives the Secretary unguided power to ‘‘deem’’ products subject to the TCA—no intelligible principle	TCA states clear purposes (public health; protect youth) and limits (statutory definition of "tobacco product"; detailed regulatory framework)	Delegation constitutional — intelligible principle satisfied
Whether statutory text and context supply limiting standards	Congress failed to provide meaningful constraints beyond saying "tobacco product"	Congress supplied purposes, findings, definitions, and detailed substantive rules that bound discretion	Text, purpose, factual findings and regulatory scheme provide adequate guidance
Whether analogous precedents (Panama Refining, Schechter) compel invalidation	Delegation is as broad as the NIRA delegations invalidated in Panama Refining and Schechter	TCA is unlike NIRA: it contains targeted purposes, definitions, and extensive regulatory detail; more like SORNA/Gundy	NIRA cases distinguishable; SORNA analogy supports validity
Procedural: entitlement to discovery & preliminary injunction	Plaintiffs sought discovery and an injunction to avert imminent enforcement	District court properly dismissed as a legal claim; discovery unnecessary; injunction unwarranted because plaintiffs unlikely to succeed on merits	Denial of discovery and preliminary injunction affirmed

Gundy v. United States, 139 S. Ct. 2116 (2019) (plurality) (upholding an executive-law-application delegation in SORNA and emphasizing statutory purpose and context in intelligible-principle analysis)
Mistretta v. United States, 488 U.S. 361 (1989) (reaffirming intelligible-principle standard and its permissive application)
J.W. Hampton Jr. & Co. v. United States, 276 U.S. 394 (1928) (establishing the intelligible-principle test for delegations)
Panama Refining Co. v. Ryan, 293 U.S. 388 (1935) (invalidating an unconstrained delegation under the NIRA)
A.L.A. Schechter Poultry Corp. v. United States, 295 U.S. 495 (1935) (invalidating a delegation that lacked standards to limit economic regulation)
Whitman v. American Trucking Ass'ns, Inc., 531 U.S. 457 (2001) (upholding broad public-health delegations where an intelligible principle exists)
Am. Power & Light Co. v. SEC, 329 U.S. 90 (1946) (describing elements that satisfy the intelligible-principle standard)