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

Swedish-Founded Nicotine Pouch Retailer GotPouches Shifts to U.S.-Based Operations, Reaching Over 25 States
Swedish-Founded Nicotine Pouch Retailer GotPouches Shifts to U.S.-Based Operations, Reaching Over 25 States
Swedish-founded online nicotine pouch retailer GotPouches has completed the localization of its U.S. operations under UpNorth Retail LLC, with corporate operations in Franklin, Tennessee, domestic fulfillment from Nashville and U.S.-based customer support. The company says its catalog covers more than 20 nicotine pouch brands and it currently serves customers in more than 25 U.S. states.
Sep.18
NATO Executive Director David Spross Sees U.S. Vape Regulation Improving, Calls for More PMTA Authorizations and Warns of 2027 State Tax Pressure
NATO Executive Director David Spross Sees U.S. Vape Regulation Improving, Calls for More PMTA Authorizations and Warns of 2027 State Tax Pressure
The National Association of Tobacco Outlets is calling for more FDA marketing authorizations, greater transparency in the PMTA process and continued enforcement against unauthorized e-cigarettes, even as its executive director, David Spross, points to recent regulatory developments as signs of progress. At the state level, excise taxes, flavor restrictions and vapor product directories remain major issues for tobacco retailers. By August 2026, 17 states had enacted laws establishing state-managed e-cigarette directories or similar systems.
Innovation
Sep.29 by 2Firsts Perspectives
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin's electronic vaping device directory has been fully enforced for more than a year, and local vape retailers say the reduced range of eligible products has contributed to declining sales, store closures and layoffs. Johnny Vapes owner Ben Hall said he has closed four of seven locations and cut about 70% of his staff. State law bars the sale of vaping devices not listed on the Wisconsin Department of Revenue directory and allows penalties of $1,000 per day for each unlisted device sold or offered for sale. In April 2026, the U.S. Court of Appeals for the Seventh Circuit allowed enforcement of the law to continue.
Regulations
Oct.10
Turning Point Brands Q3 Modern Oral Net Sales Rise 103% to $74.4 Million as Attributable Profit Falls 81%
Turning Point Brands Q3 Modern Oral Net Sales Rise 103% to $74.4 Million as Attributable Profit Falls 81%
Turning Point Brands (TPB) reported third-quarter 2026 Modern Oral net sales of $74.4 million on November 9, up 102.9% year over year and representing 49.2% of consolidated net sales. Total company net sales rose 27.0% to $151.1 million, while net income attributable to TPB declined 81.4% to $3.93 million. The company is expanding the US retail presence of its FRE and ALP nicotine pouch brands and expects its Modern Oral chain-store footprint to grow by more than 70% during 2026. Selling, general and administrative expenses increased 69.1% to $75.3 million, while PMTA-related expenses reached approximately $3.15 million and manufacturing start-up costs totaled about $593,000. ALP plans to open a branded pop-up in New York City's SoHo neighborhood on November 13, alongside a marketing campaign extending into January 2027. TPB owns 50% of ALP but consolidates the venture in its financial statements.
company
Nov.11
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
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
American Vapor Manufacturers (AVM) and Altria subsidiaries Helix Innovations and NJOY filed separate motions on October 7, 2026, seeking to intervene on the FDA's side in a lawsuit challenging its enforcement guidance for certain e-cigarette and nicotine pouch products with pending premarket tobacco product applications (PMTAs). Seven public health and tobacco-control organizations, including the Campaign for Tobacco-Free Kids, sued the agency in July to overturn the policy. AVM argues that vacating the guidance could disrupt orders, inventory, retail distribution and investments in regulatory submissions.
Regulations
Oct.09