Health Law Daily Congress’ delegation of e-cigarette regulation to FDA not unconstitutional
Monday, July 6, 2020

Congress’ delegation of e-cigarette regulation to FDA not unconstitutional

By Jeffrey H. Brochin, J.D.

Congress did not violate the non-delegation doctrine when it delegated regulation of e-cigarette and nicotine delivery products to the FDA via the Family Smoking Prevention and Tobacco Control Act, where the delegation properly asserted policy, and delineated the agency and limits.

A federal appeals court in Louisiana has affirmed the decision of the district court that dismissed a lawsuit filed by an e-cigarette manufacturer and a vaping trade association challenging FDA regulation, as established under section 901 of the Family Smoking Prevention and Tobacco Control Act (TCA) of electronic nicotine delivery systems (ENDS) as unconstitutional. The appeals court agreed with the trial court that no violation of the non-delegation doctrine occurred where Congress clearly delineated its general policy, the public agency that was to apply it, and the boundaries of that delegated authority (Big Time Vapes, Incorporated v. FDA, June 25, 2020, Smith, J.).

Products governed by the TCA. The TCA automatically covered four types of tobacco products—cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. But in section 901 of the TCA, Congress authorized the Secretary of Health and Human Services to determine which "other products" should be governed by the TCA’s regulatory scheme, and in May 2016, the FDA promulgated a rule that deemed all products meeting the statutory definition of "tobacco product," to be subject to the FDA’s tobacco product authority. Accordingly, the FDA included ENDS products under its regulatory scheme, maintaining that regulating ENDS would benefit public health. Big Time Vapes and the United States Vaping Association sued the FDA asserting that Congress’s delegation to the Secretary was unconstitutional. The district court dismissed the lawsuit and the vaping product makers and entities appealed.

Non-delegation doctrine. The appeals court began its review by noting that the nondelegation doctrine is rooted in the principle of separation of powers whereby the lawmaking function belongs to Congress who may not constitutionally delegate that power to another constitutional principal. However, that seemingly inflexible constitutional principal has long been recognized to be somewhat pliable, and the Constitution has never been regarded as denying to Congress the necessary resources of flexibility and practicality to perform its function. Furthermore, it has been well-established that delegations are constitutional so long as Congress lays down by legislative act an intelligible principle to which the person or body authorized to exercise the authority is directed to conform.

Requirements for delegation of lawmaking. In order to delegate lawmaking to an agency, it is considered constitutionally sufficient if Congress (1) clearly delineates its general policy, (2) delineates the public agency which is to apply it, and (3) defines the boundaries of that delegated authority. Although the second factor was not at issue because the TCA’s text facially designates the Secretary, the two remaining factors needed to be examined by the court.

Despite the plaintiffs’ suggestions to the contrary, the appeals court found that Congress undeniably delineated its general policy in the TCA, and specified under "Purpose," that the TCA was meant to ensure that the FDA had the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco. Another stated purpose was to provide new and flexible enforcement authority to ensure that there was effective over-sight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products.

Similarly, Congress plainly limited the authority that it delegated to the FDA including by enacting a controlling definition of "tobacco product" that necessarily restricted the power to only products meeting that definition.

No delegations unconstitutional in 80 years. The court concluded its analysis by noting the interesting historical fact that courts have found only two delegations to be unconstitutional—ever—and that none have been found to be unconstitutional in more than 80 years.

Based on the foregoing, the appeals court affirmed the trial court’s dismissal of the lawsuit finding no violation of the non-delegation doctrine.

The case is No.: 19-60921.

Attorneys: Jerad Wayne Najvar (Najvar Law Firm, P.L.L.C.) for Big Time Vapes, Inc. and United States Vaping Association, Inc. Lindsey E. Powell, U.S. Department of Justice, for Food & Drug Administration, Stephen M. Hahn and Alex M. Azar, II.

Companies: Big Time Vapes, Inc.; United States Vaping Association, Inc.; Food & Drug Administration

MainStory: TopStory CaseDecisions FDCActNews SafetyNews TobaccoNews LouisianaNews MississippiNews TexasNews

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