US Appeal Court upholds FDA's authority over e-cigarettes

Sep.09.2022
US Appeal Court upholds FDA's authority over e-cigarettes
A US appeals court upheld the FDA's authority over e-cigarette products in a case brought by Prohibition Juice.

According to a report by ECigIntelligence, a United States appeals court has upheld the Food and Drug Administration's authority over electronic cigarette products in a case that challenged a marketing denial order.


Prohibition Juice, headquartered in New York, has raised objections to the MDO, claiming that the organization lacks legal authority to consider the relative effectiveness of a product in promoting the cessation of use of combustible cigarettes compared to another product with similar health risk features and labeling.


The US Circuit Court of Appeals for the District of Columbia has ruled that the Food and Drug Administration (FDA) has the power to determine if a product is suitable for protecting public health under the Tobacco Control Act. This means that applicants must provide all information related to the investigation, as well as assess the health risks of the product and evaluate if it carries less risk than other products.


Statement


This article is compiled from third-party information and is for industry communication and learning purposes only.


This article does not represent the views of 2FIRSTS and 2FIRSTS cannot confirm the authenticity and accuracy of the article's content. The compilation of this article is for industry exchange and research purposes only.


Due to limitations in our ability to accurately translate, the compiled article may not fully reflect the original text. Please refer to the original text for accuracy.


2FIRSTS maintains complete alignment with the Chinese government on any domestic, Hong Kong, Macau, Taiwan, and foreign-related statements and positions.


The copyright of compiled information belongs to the original media and author. If there is any infringement, please contact us for deletion.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Indiana Halts Sales of Elf Bar, Lost Mary, MR FOG and iJOY Vapes Under Foreign-Adversary Rules; Some Products Return After Compliance Filings
Indiana Halts Sales of Elf Bar, Lost Mary, MR FOG and iJOY Vapes Under Foreign-Adversary Rules; Some Products Return After Compliance Filings
Indiana's Alcohol and Tobacco Commission (ATC) ordered tobacco certificate holders in September to remove certain vaping products marketed under Elf Bar, Lost Mary, MR FOG, iJOY and other brands from inventory under the state's foreign-adversary product law. The agency later listed 257 MR FOG products and 77 Lost Mary product entries as lawful for sale. The Lost Mary revision expressly stated that compliance evidence had been received for 20 additional products. 2Firsts compliance expert Kurt said potential filings could include e-liquid and ingredient-origin records, U.S. nicotine-analog supply-chain documentation and FDA premarket application status.
Regulations
Oct.08
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Three R.J. Reynolds companies are seeking to intervene in a lawsuit filed by Altria subsidiaries Helix Innovations and NJOY challenging the FDA's 2021 PMTA final rule. The companies dispute how the agency uses Acceptance and Filing reviews and completeness determinations to establish when the Tobacco Control Act's 180-day decision period begins. Reynolds has also linked prolonged PMTA reviews to competition from unauthorized vaping products. The FDA, meanwhile, has been accelerating reviews and reducing its backlog.
Sep.14
Product | SnowPlus Launches Nicotine-Free DASH in South Korea, Localising an Established Disposable Platform
Product | SnowPlus Launches Nicotine-Free DASH in South Korea, Localising an Established Disposable Platform
SnowPlus has introduced a nicotine-free version of DASH in South Korea, adapting an existing overseas disposable platform for the local market. The Korean version retains the series’ flat duckbill-style mouthpiece, ceramic heating architecture and disposable form factor while reducing nicotine content to 0%. By comparison, the overseas DASH 4000 platform typically features 7.5ml of prefilled e-liquid, up to 4,000 puffs and a 530mAh rechargeable battery, with nicotine-containing variants available in some markets. The product update centers on formulation localisation rather than a new hardware generation.
Aug.31
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.
FDA
Sep.30
2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
2Firsts Interview | Cigarette Sales Fall as Smokeless Alternatives Gain in U.S. Convenience Stores, NACS Says
Ahead of the 2026 NACS Show, 2Firsts interviewed Chris Rapanick, NACS managing director of research, on changes reshaping the U.S. convenience-store tobacco and nicotine market. NACS data show cigarette sales declining while smokeless alternatives, including nicotine pouches, continue to grow. The interview also examines higher OTP margins, shifting backbar space, weaker store traffic, regulatory uncertainty and NACS’ outlook for 2027, offering a retailer-side view of one of the world’s largest nicotine markets.
Interview
Oct.03