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

HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation Limited has been granted a Chinese invention patent covering 6-methylnicotine salt formulations and their use in oral and vaping products. The technology forms salts between 6-methylnicotine and alicyclic carboxylic acids, with granted claims extending to oral products, atomization substrates and electronic atomization devices. Applicant-generated tests reported differences in oxidation stability, in-vitro cytotoxicity and aerosol heavy-metal performance compared with selected benzoate or lactate controls. HG Innovation is directly linked to the broader IMiracle and ELFBAR business network.
Sep.04
Juul Sublicense Reshapes Vuse Alto Patent Bill as Court Ends R.J. Reynolds’ 5.25% Royalty Obligation to Altria
Juul Sublicense Reshapes Vuse Alto Patent Bill as Court Ends R.J. Reynolds’ 5.25% Royalty Obligation to Altria
According to Law360 on August 31, 2026, a federal judge in North Carolina ruled that a patent sublicense between R.J. Reynolds Vapor Co. and Juul Labs Inc. relieves Reynolds of its obligation to continue paying royalties to Altria Client Services LLC over Vuse Alto. A jury had previously found that Vuse Alto infringed three Altria patents and awarded approximately $95.2 million in past damages, after which Reynolds was ordered to pay an ongoing royalty equal to 5.25% of positive net sales. The new ruling finds that a valid sublicense can eliminate future infringement, potentially ending what Altria described as hundreds of millions of dollars in future royalties.
Sep.01
UK Reform Party Proposes Cap of 1,000 Vape Shops Under Plan to Tighten Retail Controls
UK Reform Party Proposes Cap of 1,000 Vape Shops Under Plan to Tighten Retail Controls
The UK Reform Party has proposed limiting the number of dedicated vape shops in the country to around 1,000 as part of a plan to tighten oversight of vape retail channels. The proposal was put forward by Reform UK deputy leader and MP Lee Anderson. The plan remains a political proposal and has not become UK government policy, with no detailed legislation, implementation timeline or allocation rules announced.
Aug.10
South Korean Lawmaker Jeong Jin-wook Pushes Synthetic Nicotine Vape Probe, Highlighting Supply Chain and Tax Concerns
South Korean Lawmaker Jeong Jin-wook Pushes Synthetic Nicotine Vape Probe, Highlighting Supply Chain and Tax Concerns
South Korean lawmaker Jeong Jin-wook has again called for stronger government action against liquid synthetic nicotine vape manufacturers and sellers, alleging that some businesses may have avoided regulation through product labeling changes and corporate restructuring. According to Newsworks, JNILBO and other Korean reports, Jeong has held his third press conference on the issue, calling for a government-wide investigation. The dispute involves whether synthetic nicotine products should fall under tobacco regulations, tax implications and supply-chain transparency. South Korean government agencies have previously said some estimates of potential tax losses cannot be verified due to limited sales data.
Jul.27
Ohio Supreme Court Weighs Whether State Consumer Law Can Restrict Flavored Vape Sales
Ohio Supreme Court Weighs Whether State Consumer Law Can Restrict Flavored Vape Sales
The Ohio Supreme Court is hearing a case involving flavored vape sales and whether state authorities can use consumer protection laws to take action against retailers selling unauthorized vape products. Ohio officials argue that selling unauthorized flavored vapes may constitute consumer deception, while retailers argue that tobacco product regulation falls under federal Food and Drug Administration (FDA) authority and that states cannot impose additional restrictions through consumer laws. The case could affect the scope of state-level vape regulation across the United States.
Aug.06
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
China-based China Tobacco Hubei Industrial Co., Ltd. has filed a patent application covering an oral nicotine product and its preparation method. The patent proposes a soft candy-shaped oral nicotine product containing nicotine ingredients, gelling agents, sweeteners and alkaline pH regulators. Through formulation adjustments and homogeneous or dual-layer structures, the technology aims to achieve different nicotine release profiles. The filing reflects exploration of new oral nicotine product formats and controlled nicotine delivery approaches.
Aug.06