In an amicus curiae brief, a collection of vaping companies and trade associations has petitioned the U.S. Supreme Court to reverse or modify the so-called Chevron deference in a case unrelated to vaping. The court's ruling will influence the way lower court judges will rule in future cases involving disagreements over administrative agency measures, such as the FDA's regulation of vaping products.
Established in the 1984 Supreme Court decision Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., the Chevron deference, also known as the Chevron Doctrine, is a legal doctrine that calls for courts to defer to an administrative agency's interpretation of ambiguous statutes so long as the agency's interpretation is reasonable and Congress did not directly address the issue in question when writing the law.
In the case of Loper Bright Enterprises v. Raimondo, which is currently before the Supreme Court, a family-run herring fishing business is contesting a federal agency order that required the fishing sector to cover the expenses of federal fishery monitoring in New England. A ruling is expected in the upcoming year, since the court has committed to consider the matter during its subsequent session. Many analysts believe that the conservative majority on the court is prepared to break with Chevron deference.
Chevron deference debates typically align with either liberal or conservative political ideologies. Liberals want agencies with impartial knowledge to resolve regulatory matters, while conservatives are against giving unelected bureaucrats unlimited authority. If the Supreme Court's ruling restricts or does away with Chevron deference, it will have an impact on how Congress drafts laws, how federal agencies implement them, and how the courts interpret them.
Courts deciding on federal lawsuits pertaining to vaping have been prevented from challenging the FDA's interpretation of its authority as outlined in the 2009 Family Smoking Prevention and Tobacco Control Act due to Chevron's deference. The FDA gave itself the right to regulate e-cigarettes as tobacco products in 2016 with the Deeming Rule. Since then, most courts have determined that the agency's actions were "reasonable" and, as a result, are not subject to dispute under Chevron deference.
Two of the co-authors of the amicus brief, attorneys Azim Chowdhury and Eric Gotting of the Washington, D.C. law firm Keller and Heckman, explain in a blog post that following the 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."
Two of the co-authors of the amicus brief, attorneys Azim Chowdhury and Eric Gotting of the Washington, D.C. law firm Keller and Heckman, explain in a blog post that following the 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!"
The amicus brief details how the FDA's enforcement and regulation of vaping businesses, particularly the premarket tobacco application (PMTA) review process, has been impacted by Chevron's deference. This is because the Tobacco Control Act mandates that the FDA evaluate each application on its own.
"However, in a Chevron world, the FDA has 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, going far beyond the statute's plain language and goals," Chowdhury and Gotting write.
Numerous businesses that the FDA refused marketing authorization have sued the agency, contesting the agency's jurisdiction to grant those "cookie-cutter MDOs." However, a majority of them have faced judges who are hesitant to overturn the agency, frequently because of Chevron. The end consequence is that, despite the FDA never having established a regulation banning non-tobacco flavors, not a single non-tobacco-flavored vaping product has been approved.
- Gregory Troutman of the Troutman Law Office in Louisville, Kentucky, is the third co-author of the amicus brief, following Chowdhury and Gotting. Manufacturers of e-liquid and devices, flavoring firms, vape merchants, and state trade associations are among the 25 signatories to the brief:
- American Vape Company, LLC
- American Vaping Manufacturers Association
- American Vapor Group (Red Star Vapor)
- Bidi Vapor, LLC
- Ecig Charleston LLC
- Flavour Art North America
- Florida Smoke Free Association, Inc.
- FLV USA (Flavorah)
- Indiana Smoke Free Alliance, Inc.
- Kentucky Vaping Retailers Association, Inc.(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 (BLVK E-Liquid)
- Wages and White Lion Investments, LLC (Triton Distribution)
- White Horse Vapor
- YLSN Distribution LLC (Happy Distro)
