New Civil Liberties Alliance Challenges FDA Regulations in Court

Dec.24.2024
New Civil Liberties Alliance Challenges FDA Regulations in Court
NCLA urges Supreme Court to reject FDA's attempt to evade responsibility in Reynolds Tobacco case.

According to a report from Globe Newswire on December 23rd, the New Civil Liberties Alliance (NCLA) has filed an amicus brief in support of the defendant with the Supreme Court of the United States. In the case of FDA v. Reynolds Tobacco (R.J. Reynolds Vapor Company), NCLA is urging the Supreme Court to reject the FDA's attempt to shift blame.


Although the law allows "any person adversely affected by an FDA order" to challenge the agency's decisions in court, the FDA claims that the ban on e-cigarette sales has not adversely affected such retailers. The FDA is asking the Supreme Court to limit the right to challenge to parties involved in the administrative process. The alliance argues that this restriction would conflict with relevant laws and precedents set by the Supreme Court.


According to the Family Smoking Prevention and Tobacco Control Act (TCA), manufacturers need to obtain FDA approval in order to sell certain e-cigarette products. Reynolds Tobacco applied to sell its "Vuse" e-cigarette, but the FDA rejected the application, meaning all retailers are now prohibited from selling the "Vuse" e-cigarette. However, these products are allowed to be sold during the application review process. As a result, some retailers have filed a petition with the United States Court of Appeals for the Fifth Circuit, claiming that the FDA's decision has caused them financial losses and has had a detrimental impact on their businesses.


However, the FDA rejected their request, believing that under the Family Smoking Prevention and Tobacco Control Act (TCA), the only individuals considered to be "adversely affected" are manufacturers who have submitted applications but were denied. The Fifth Circuit Court of Appeals in the United States rejected the FDA's argument, ruling that retailers are eligible to petition for review of the order. The Supreme Court agreed to hear the case in order to resolve the issue and determine whether the venue court is appropriate.


This case could have far-reaching implications. If the FDA successfully narrows the scope of the judicial review provision of the Family Smoking Prevention and Tobacco Control Act (TCA), similar restrictions could be applied to many other regulations across the country that provide for judicial review of agency actions. This would prevent many individuals and businesses affected by agency actions from seeking relief in federal courts.


NCLA CEO Mark Chenoweth stated,


E-cigarette regulation is not a concern of the NCLA. However, the key issue in this case is whether retailers can sue the FDA for orders prohibiting the sale of their products, or if only manufacturers can challenge such orders. Since Congress has enacted judicial review regulations that encompass retailers, they should be able to sue the FDA directly.


According to reports, NCLA is a nonprofit public interest law firm ranked 501, founded by Columbia Law School professor Philip Hamburger in 2017. The organization aims to challenge what it perceives as the unlawful use of executive power.


We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's Ministry of Gender Equality and Family said on September 14 that it plans to designate unmanned e-cigarette stores as businesses where minors are prohibited from entering or working. Operators would be required to verify customers' ages and display notices restricting access by minors. The proposal is open for public comment through October 6. The move follows an April expansion of South Korea's statutory tobacco definition that brought products made with natural or synthetic nicotine under the Tobacco Business Act. Nicotine-free liquids and products using nicotine analogues such as 6-methylnicotine, however, remain an emerging regulatory issue.
Sep.21
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia Withdraws Appeal Against Liquid Nicotine Ruling as Vape Regulation Framework Enters New Phase
Malaysia’s government has withdrawn its appeal against a High Court ruling concerning the regulatory status of liquid nicotine used in vape and e-cigarette products, according to reports by New Straits Times, Free Malaysia Today and CodeBlue on August 18, 2026. The Kuala Lumpur High Court ruled on May 15 that the government’s decision to remove liquid nicotine from the scheduled poisons list under the Poisons Act 1952 was irrational and made without proper consultation with the Poisons Board. The withdrawal ends the government’s appeal process, while the future regulatory framework for nicotine vape products remains under discussion.
Aug.21
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
U.S. Fifth Circuit Vacates NicQuid Vape MDO, Says FDA Comparative-Efficacy Standard Violated APA Procedures
According to VitalLaw on August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit vacated an FDA marketing denial order (MDO) against NicQuid LLC, ruling that the agency’s comparative-efficacy standard for electronic nicotine delivery system (ENDS) applications had become a substantive rule requiring notice-and-comment rulemaking under the Administrative Procedure Act (APA). The court did not reject FDA’s authority to compare the public health benefits and risks of flavored vapes, but held that the agency could not establish a broadly binding standard through informal adjudications. The case was remanded to FDA for further proceedings.
Aug.28
China’s HTP Exports Fell 14.3% in H1 2026 as Russia and Belarus Accounted for 76% Lead
China’s HTP Exports Fell 14.3% in H1 2026 as Russia and Belarus Accounted for 76% Lead
In H1 2026, China’s HS 24041100 exports stood at $1.32 million, down 14.3% YoY, with volume falling 17.2% to 55.33 tons. Market distribution shifted drastically amid overall export drops. Exports to Russia and Belarus totaled $1 million, taking 76.0% of all shipments versus 29.5% in H1 2025. Belarus became the top destination with export value jumping 177.5%, while the Philippines, Singapore and Indonesia’s combined share slumped from 49.3% to 11.2%.Domestically, Yunnan led exporter registrations; Jiangsu and Shanghai were key suppliers, yet Anhui and Sichuan had no exports. Heavy concentration means order or declaration changes for Russia/Belarus greatly affect national aggregate data. The data shows customs entry points (not end markets), covering tobacco consumables only, excluding heating equipment and the complete HTP supply chain.
Aug.11
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
The FDA has authorized four additional on! nicotine pouches, bringing the U.S. total to 30. The decision marks another outcome of the agency’s nicotine pouch review pilot, whose communication and review practices are now being applied more broadly across the category. It also extends Helix’s authorized portfolio from on! PLUS to the earlier on! line. Yet all FDA-authorized nicotine pouches still come from subsidiaries of PMI or Altria, underscoring how concentrated U.S. regulatory access remains.
Aug.05