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

2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
2Firsts Data|China’s Vape-Related Exports Rose 3.3% in August 2026 as UK Shipments Jumped 51.4% and U.S. Exports Fell 12.4%
China exported $979 million of vape-related products in August 2026, up 3.3% from a year earlier but down 6.4% from July. The UK replaced the U.S. as the main source of growth: UK-bound shipments jumped 51.4% to a 2026 high of $177 million, while exports to the U.S. fell 12.4% to $339 million. Shipments to markets outside the U.S. increased 14.2%, broadening growth beyond the market that had driven July’s rebound.
News
Sep.23 by 2Firsts Perspectives
India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India's Ministry of Health and Family Welfare has directed states to step up enforcement against nicotine pouch sales, citing increased availability through online and offline channels and concern about nicotine exposure among children. Reuters reported that international brands including ZYN and White Fox are being sold in India. A study led by ICMR-NICPR found pouches in seven of 10 surveyed locations and identified 68 brands and 445 flavors online. Separately, India's Drugs Technical Advisory Board recommended in August that no new nicotine formulation be approved.
Regulations
Sep.28 by 2Firsts Perspectives
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.
Regulations
Oct.06
Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italian Financial Police Seize 4.3 Million E-Cigarettes and Smoking Accessories; 28 Reported to Judicial Authorities Across Operations
Italy's Guardia di Finanza announced on October 28 that officers in Latina province had seized approximately 4.3 million e-cigarettes and smoking accessories at an unauthorized warehouse in an operation involving restrictions on the possession and sale of tobacco-related products. Another 300,000 suspected counterfeit or unsafe items were confiscated during separate inspections, bringing total seizures across the operations to more than 4.6 million products. Twenty-eight people were reported to judicial authorities over suspected smuggling and counterfeiting offenses. Officials did not disclose separate vape quantities, the value of the merchandise or alleged violations associated with individual brands.
Enforcement
Oct.29
China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery
China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery
China Tobacco Hubei Industrial Co., Ltd. disclosed several oral nicotine-related patent applications in August 2026, including two that approach staged nicotine release from different directions. One uses a high-viscosity membrane that forms inside the pouch after contact with saliva to slow rapid early release, while the other uses gradient particles with a faster-disintegrating outer layer and a slower core to create a fast-to-sustained release profile. Together, the filings explore how nicotine pouches could balance initial delivery with release later in use.
Sep.03
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
AIRSCREAM’s production hub in the Czech Republic brings nicotine pouch manufacturing, e-liquid bottling, product documentation, warehousing and international logistics into one operation, giving brands and commercial partners a practical platform from which to launch, expand and enter new markets.
Market
Sep.16 by 2Firsts Perspectives