Big Time Vapes, Inc. v. Food & Drug Admin.

• Decision Date: 25 June 2020
• Docket Number: No. 19-60921,19-60921
• Citation: 963 F.3d 436
• Parties: BIG TIME VAPES, INCORPORATED ; United States Vaping Association, Incorporated, Plaintiffs-Appellants, v. FOOD & DRUG ADMINISTRATION; Stephen M. Hahn, Commissioner of Food and Drugs; Alex M. Azar, II, Secretary, U.S. Department of Health and Human Services, in his official capacity, Defendants-Appellees.
• Court: U.S. Court of Appeals — Fifth Circuit

963 F.3d 436

BIG TIME VAPES, INCORPORATED ; United States Vaping Association, Incorporated, Plaintiffs-Appellants,

v.FOOD & DRUG ADMINISTRATION; Stephen M. Hahn, Commissioner of Food and Drugs; Alex M. Azar, II, Secretary, U.S. Department of Health and Human Services, in his official capacity, Defendants-Appellees.

No. 19-60921

United States Court of Appeals, Fifth Circuit.

FILED June 25, 2020

Jerad Wayne Najvar, Esq., Austin M.B. Whatley, Najvar Law Firm, P.L.L.C., Houston, TX, for Plaintiffs-Appellants

Lindsey E. Powell, Esq., U.S. Department of Justice, Washington, DC, for Defendants-Appellees

Before SMITH, HIGGINSON, and ENGELHARDT, Circuit Judges.

JERRY E. SMITH, Circuit Judge:

The Family Smoking Prevention and Tobacco Control Act¹ establishes a thorough framework for regulating tobacco products. Four such products—cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco—are automatically subject to the Act. But in section 901 of the TCA, Congress authorized the Secretary of Health and Human Services ("the Secretary") to determine which other products should be governed by the TCA's regulatory scheme. Big Time Vapes, Incorporated, and the United States Vaping Association sued the Food and Drug Administration ("FDA"), its Commissioner, and the Secretary, asserting that Congress's delegation to the Secretary was unconstitutional. The district court dismissed, and we affirm.

I.

The facts are not disputed. This appeal turns on a purely legal question: Whether section 901's delegation to the Secretary violates the nondelegation doctrine.

A.

In 2009, Congress enacted the TCA, thereby amending the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq . Congress sought to empower the FDA to regulate tobacco products,² whose use Congress found to be "the foremost preventable cause of premature death in America." TCA § 2(13), 123 Stat. at 1777. "Because past efforts to restrict advertising and marketing of tobacco products ha[d] failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products [we]re needed." Id . § 2(6). Accordingly, Congress gave the FDA broad authority to address "the public health and societal problems caused by the use of tobacco products." Id . § 2(7).

To advance its public-health purpose, Congress established a detailed framework for regulating tobacco. But that statutory scheme did not apply—at least not immediately—to all forms of tobacco. Instead, Congress automatically applied the TCA "to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco."³ Section 901 provided that the TCA also would apply "to any other tobacco products⁴ that the Secretary [of Health and Human Services]⁵ by regulation deems to be subject to [the Act]." Id . § 387a(b).

The TCA imposes several requirements on "tobacco product manufacturers."⁶ They must submit to the FDA truthful information about their products, including: (1) "all ingredients, [i.e. ,] tobacco, substances, compounds, and additives"; (2) "[a] description of the content, delivery, and form of nicotine in each tobacco product"; and (3) certain information, including manufacturer-developed documents, related to the "health, toxicological, behavioral, or physiologic effects of current or future tobacco products" and their component parts. Id . § 387d(a). Manufacturers must file annual registration statements listing all tobacco products they make, id . § 387e(i)(1), and those lists must be updated biannually to reflect current offerings, id . § 387e(i)(3).

The TCA likewise prohibits manufacturers from introducing any "new tobacco product" without premarket authorization. Id . § 387j(a). A tobacco product is considered "new" if it "was not commercially marketed in the United States as of February 15, 2007."⁷ A manufacturer can obtain premarket authorization through two primary channels: (1) by tendering a "premarket tobacco application" ("PMTA") demonstrating that the product "would be appropriate for the protection of the public health," id . § 387j(a)(2), (c)(2)(A); or (2) by submitting a "report" showing that the product "is substantially equivalent to a tobacco product commercially marketed" before February 2007, id . § 387j(a)(2)(A)(i).⁸ The PMTA process is onerous, requiring manufacturers to gather significant amounts of information.⁹

Finally, the FDA can impose additional rules by regulation, such as minimum-age restrictions, mandatory health warnings, method-of-sale limits, and advertising constraints. See id. § 387f(d). Failing to comply with the TCA's or the FDA's regulations has serious consequences. A non-compliant manufacturer's product may be designated as "adulterated" or "misbranded," see id . §§ 387b, 387c, which could result in, among other things, civil penalties, see id . § 333(f)(8)–(9), or seizure of the offending product, see id . § 334.

B.

In May 2016, the FDA promulgated a rule that "deem[ed] all products meeting the statutory definition of ‘tobacco product,’ except accessories of the newly deemed tobacco products, to be subject to FDA's tobacco product authorities under [the TCA]."¹⁰ That swept into the TCA's ambit several popular tobacco products, including Electronic Nicotine Delivery Systems ("ENDS").¹¹ The FDA maintained that regulating ENDS would benefit public health, because (1) those products had the potential to effect public harm, and (2) regulation would permit the FDA to "learn more about that potential." Deeming Rule, 81 Fed. Reg. at 28,983. That was especially true given that long-term studies hadn't yet been conducted to determine whether ENDS products were harmful or beneficial to public health. Id . at 28,984.

As a result of the FDA's rule, ENDS and e-liquid producers were "subject to all of the statutory and regulatory requirements applicable to [tobacco] manufacturers," including the TCA's reporting, registration, and premarket authorization mandates. Id . at 29,044. The FDA required compliance with some TCA provisions as soon as the Deeming Rule became effective,¹² but the FDA indicated that it would not enforce the premarket-review provisions, for products already on the market, for several years following the rule's effective date.¹³ For any new products, however, tobacco manufacturers had to obtain premarket authorization before those products could be sold. Id . at 28,978. Because ENDS technology is relatively young—i.e. , there were very few (if any) products on the market before February 2007—ENDS products and e-liquids are effectively required to submit PMTAs. See id . at 28,978 –79.

C.

Big Time Vapes, a small-business manufacturer and retailer of e-liquids, and the United States Vaping Association, an ENDS industry trade association, sued the FDA, contending that the TCA unconstitutionally delegated to the Secretary the power to deem tobacco products subject to the Act's mandates. The plaintiffs requested, inter alia , (1) a declaration that section 901 violates the nondelegation doctrine and (2) an injunction preventing the FDA from enforcing the TCA against them.

Shortly after filing suit—and in response to a forthcoming change in federal enforcement strategy—the plaintiffs moved for a preliminary injunction enjoining the FDA "from exercising any authority over any ‘tobacco products’ deemed to be subject to the TCA...." The FDA opposed the plaintiffs’ motion and separately moved to dismiss under Rule 12(b)(6). The plaintiffs countered the FDA's motion by asserting that they were entitled to reasonable discovery.

The district court found no nondelegation violation and dismissed the suit. The court determined that Congress had articulated a sufficiently intelligible principle—specifically, "a desire to protect the public health and to prevent, to the extent possible, underaged persons from having access to tobacco products"—for the delegation to pass constitutional muster. Moreover, the court concluded that the FDA's power was adequately constrained, because (1) "Congress ... restricted the FDA's discretion with a controlling definition of ‘tobacco product,’ " and (2) "Congress, itself, designated certain tobacco products as governed by the TCA and presented detailed policies behind its enactment of the TCA." The court naturally denied a preliminary injunction. The plaintiffs appeal.

II.

We review Rule 12(b)(6) dismissals de novo . In re IntraMTA Switched Access Charges Litig. , No. 18-10768, 961 F.3d 691, 712–13, 2020 U.S. App. LEXIS 16844 at *58 (5th Cir. May 27, 2020). Whether a statute violates the nondelegation doctrine is a legal question we review de novo . See United States v. Johnson , 632 F.3d 912, 917 (5th Cir. 2011).

A.

"All legislative Powers herein granted shall be vested in a Congress of the United States." U.S. CONST. art. I, § 1. "Accompanying that assignment of power to Congress is a bar on its further delegation." Gundy v. United States , ––– U.S. ––––, 139 S. Ct. 2116, 2123, 204 L.Ed.2d 522 (2019) (plurality). "Th[at] nondelegation doctrine is rooted in the principle of separation of powers that underlies our tripartite system of Government." Mistretta v. United States , 488 U.S. 361, 371, 109 S.Ct. 647, 102 L.Ed.2d 714 (1989). "[T]he lawmaking function belongs to Congress," Loving v. United States , 517 U.S. 748, 758, 116 S.Ct. 1737, 135 L.Ed.2d 36 (1996), and Congress "may not constitutionally delegate [that] power to another" constitutional principal, Touby v. United States , 500 U.S. 160, 165, 111 S.Ct. 1752, 114 L.Ed.2d 219 (1991).

But that seemingly inflexible constitutional text has long been recognized to be somewhat pliable.¹⁴ "The Constitution has never been regarded as denying to the Congress the necessary resources of flexibility and practicality to perform its function." Yakus v. United States , 321 U.S. 414, 425, 64 S.Ct. 660, 88 L.Ed. 834 (1944) (ellipsis omitted). Delegations are constitutional so long as Congress "lay[s] down by legislative act an intelligible...