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United States Vaping Association Challenges FDA Regulation as Violation of Separation of Powers
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If Plaintiffs Succeed, FDA's Attempt to Regulate Vaping and Cigars Will Be Completely Invalidated Until Congress Speaks
HOUSTON, TEX.—Yesterday, a lawsuit was filed in Mississippi federal district court raising a new constitutional challenge to the FDA’s 2016 decision to “deem” vaping and cigars to be subject to the same regulation Congress applied to cigarettes and smokeless tobacco. While numerous cases are already pending in which vape and cigar businesses are challenging the FDA’s so-called “Deeming Rule” under various theories, this new suit focuses exclusively on a single argument that has not been raised in any other case. If Plaintiffs win, it would not merely change the compliance deadline or tinker with the details of the FDA’s regulations, but would completely invalidate FDA’s attempt to regulate any “tobacco products” other than cigarettes and smokeless tobacco, unless and until Congress acts.
The lawsuit was filed on behalf of the United States Vaping Association (USVA), a trade association representing small businesses in the vaping industry, and one of its members, Big Time Vapes, Inc., a vape shop employing six people in Picayune, Mississippi. Belinda Dudziak, the owner of Big Time Vapes, was able to quit smoking traditional cigarettes entirely within four days of picking up her first e-cigarette, and now vapes without any nicotine at all.
The suit challenges a provision of the Family Smoking Prevention & Tobacco Control Act of 2009 (“Tobacco Control Act”), a comprehensive regulatory scheme that Congress only applied to cigarettes and “smokeless tobacco,” even though many other forms of tobacco were in wide and longstanding use at the time the Act was passed. While Congress itself only applied the Tobacco Control Act to cigarettes and smokeless tobacco (essentially chewing tobacco), a provision in the Act grants the Executive branch the power to “deem” the law to apply to any other “tobacco products,” with no guidance or factors to consider in deciding which products should be regulated like cigarettes, or in what circumstances.
Specifically, 21 U.S.C. § 387a(b) provides that the Tobacco Control Act shall apply to cigarettes and smokeless tobacco, and to “any other tobacco products that the Secretary [of Health and Human Services] by regulation deems to be subject to [the Act].” The lawsuit argues that, in transferring the power to deem other products subject to the Tobacco Control Act—with no parameters or factors to guide the “deeming” decision—Congress violated the “nondelegation” principle. Article I of the Constitution say that “[a]ll legislative Powers herein granted shall be vested in a Congress of the United States,” and the nondelegation principle holds that Congress cannot transfer its “legislative” power—the power to make policy—to another branch of government. This principle has been recognized as a bedrock of the separation of powers since the inception of the Constitution. America’s fourth Chief Justice, John Marshall, wrote in 1825 that Congress may not “delegate … powers which are strictly and exclusively legislative.”[1] The Supreme Court has twice applied the nondelegation principle to strike down executive action, but those cases were issued in 1935. While those cases remain good law, the Supreme Court has not invalidated any other delegations as excessive in the 80 years since, applying a deferential test and allowing the growth of the modern administrative state. However, in June 2019, the Supreme Court’s split decision in Gundy v. United States, 139 S. Ct. 2116 (2019), reflects that there might now be a majority on the Court ready to reinvigorate the doctrine.
“It’s clear from Gundy that there may be five votes on the Court now to put some teeth back into this principle,” said attorney Jerad Najvar, lead counsel for the Plaintiffs. “In fact, we believe the delegation of authority here is actually broader than previous delegations upheld by the Court, and could be struck down under the caselaw already on the books,” continued Najvar. “We will make that argument to the district court. But we are prepared to take this to the Supreme Court if necessary.” Najvar is principal attorney of Najvar Law Firm, PLLC (NLF), a Houston-based firm experienced in constitutional litigation. NLF associate Austin Whatley and Spencer Ritchie of Forman Watkins & Krutz LLP (Jackson, MS) are also representing Plaintiffs.
The case is Big Time Vapes, Inc. v. Food and Drug Administration., No. 1:19-cv-531-HSO-JCG, pending in the U.S. District Court for the Southern District of Mississippi.
READ THE LAWSUIT HERE
Najvar Law Firm, PLLC, based in Houston, focuses on litigation and appeals in election and constitutional matters. NLF has successfully litigated several constitutional cases, including a 2014 victory at the U.S. Supreme Court in McCutcheon v. FEC, striking down the federal aggregate limits on campaign contributions under the First Amendment.
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[1] Wayman v. Southard, 23 U.S. (10 Wheat.) 1, 42-43 (1825).
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