Photo of Azim ChowdhuryPhoto of Eric P. Gotting

On July 24, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, along with co-counsel, on behalf of members of the Electronic Nicotine Delivery Systems (ENDS) industry[i], filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of petitioners in Loper Bright Enterprises v. Raimondo[ii], on the question of whether to overturn or limit Chevron deference.

Image of the amicus brief of Loper Bright Enterprises v. Gina Raimondo; electronic nicotine delivery system industry stakeholders

Chevron deference, named after the SCOTUS decision in Chevron v. Natural Resources Defense Council, 467 U.S. 837 (1984), is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable.  In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, oftentimes bypassing the rulemaking process otherwise required under the Administrative Procedure Act (APA) and making it more difficult to challenge an agency action in court. SCOTUS overruling or limiting Chevron deference would constitute a watershed decision in administrative law, significantly increasing the potential for businesses, organizations, and individuals to successfully challenge administrative actions in court.

In the years since ENDS products became subject to U.S. Food and Drug Administration (FDA) regulation following the 2016 “Deeming Rule,” the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have simply rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the ‘appropriate for the protection of the public health’ (APPH) standard. As detailed in the ENDS industry brief, amici are national and state trade associations, small businesses, manufacturers, distributors, and retailers of ENDS who are specifically concerned that Chevron deference has enabled FDA to impermissibly interpret the TCA to implement a de facto ban on all non-tobacco flavored ENDS products, without any requisite notice and comment rulemaking or congressional amendments to the TCA.

The brief provides relevant background on the impact that Chevron deference has had on the ENDS industry, highlighting the challenges industry has faced with FDA’s Premarket Tobacco Product Application (PMTA) review process. Specifically, amici point out that the plain language of the TCA requires FDA to review each PMTA individually and balance numerous factors in deciding whether a particular product is APPH. And this is consistent with one of the TCA’s underlying purposes – to promote the development and marketing of lower-risk tobacco products. But in a Chevron world, FDA has ventured far beyond the statute’s plain language and goals, and instead issued cookie-cutter marketing denial orders (MDOs) for well over a million non-tobacco flavored products based on only a cursory review of those applications. Amici therefore urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. Lower courts should adhere to the plain language and overall context of a statute and not otherwise reflexively defer to agency interpretations, particularly those that have little basis in the statute itself.

SCOTUS granted the writ of certiorari on May 1, 2023, and limited the case to the question of whether the Chevron doctrine should be limited or overruled. Oral arguments will be scheduled for the 2023 Fall term. We will keep you updated with the progress of the appeal.

[i] The following are listed as ENDS industry amici: American Vape Company, LLC; American Vaping Manufacturers Association; American Vapor Group, d/b/a/ Red Star Vapor; Bidi Vapor, LLC; Ecig Charleston LLC; Flavour Art North America; Florida Smoke Free Association, Inc.; FLV USA, d/b/a/ Flavorah; Indiana Smoke Free Alliance, Inc.; Kentucky Vaping Retailers Association, Inc., d/b/a Kentucky Smoke Free Association; Matrix Minds, LLC; Michigan Vape Shop Owners, Inc.; Montana Smoke Free Association, Inc.; NicQuid, LLC; Ohio Vapor Trade Association Inc.; Pastel Cartel, LLC; South Carolina Vapor Associations; SS Vape Brands; Streamline Group/MH Global; SV3, LLC; Tennessee Smoke Free Association, Inc.; Vape Element LLC, d/b/a/ BLVK E-Liquid; Wages and White Lion Investments, LLC, d/b/a/ Triton Distribution; White Horse Vapor; YLSN Distribution LLC, d/b/a Happy Distro.

[ii] Petitioners are a group of fishing companies challenging The National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors. A divided panel of the U.S. Court of Appeals for the D.C. Circuit held that the construction of the statute was reasonable. See Loper Bright Enters. v. Raimondo, 544 F. Supp. 3d 82 (D.D.C. 2021).