U.S. Appeals Court Overturns FDA's E-cigarette Marketing Denial Order

Aug.05.2024
U.S. Appeals Court Overturns FDA's E-cigarette Marketing Denial Order
The Fifth Circuit Court of Appeals cited Triton Distribution's ruling as precedent, overturning FDA's Marketing Denial Orders for five e-cigarette manufacturers.

According to a recent report by Vaping 360, on July 31st, a panel of three judges from the United States Fifth Circuit Court of Appeals cited their ruling in the Triton Distribution case as precedent, approving the review requests of five e-cigarette manufacturers and overturning the FDA's Market Denial Order (MDO).


The court has remanded the case back to the FDA for further review.


These five manufacturers can now continue to sell their products until the agency conducts a new scientific review of their pre-market tobacco product application (PMTA), or until the Supreme Court takes action.


The five companies are:


Cloud House, LLC, Paradigm Distribution, SWT Global Supply, Inc., Vaporized, Inc., and SV Packaging, LLC were all involved in a court ruling that stated: (1) the FDA did not provide fair notice to e-cigarette manufacturers about the long-term research requirements for PMTAs; (2) the FDA did not acknowledge or fully explain its changing position; (3) the FDA disregarded the manufacturers' reasonable and serious reliance interests as outlined in guidance prior to the market denial order (MDO).


In January of this year, the Fifth Circuit Court of Appeals ruled in favor of Triton Distribution (appearing in court documents under its legal name Wages and White Lion Investments) with a 10-6 decision in their appeal against the FDA Market Denial Order (MDO).


Two months later, the FDA applied to the Supreme Court for a review of the Fifth Circuit Court of Appeals' ruling, and last month the Supreme Court agreed to hear the FDA's appeal.


This case may be decided in the spring of next year, potentially reshaping the FDA's regulation practices regarding e-cigarette products.


The Fifth Circuit Court of Appeals believes that the issues raised in this week's ruling are similar to those in the Triton case.


In this case, the applicant produces flavored e-cigarette liquid containing nicotine. The applicant spent a significant amount of time and resources preparing their PMTA in accordance with FDA guidance, which stated they did not need to submit long-term clinical studies. However, the FDA used the same boilerplate language to reject their PMTA, just as they have done with Wages petitioners and thousands of other e-cigarette manufacturers. Therefore, for the reasons fully explained in the Wages case, we believe the FDA's actions in this case are also unlawful, as they rejected the applicant's PMTA on the basis of lack of long-term clinical studies.


These five companies submitted petitions to the court in October 2021, questioning the MDOs received in August and September of that year. These refusals were part of the early refusal letters issued one year after the September 2020 PMTA submission deadline. The court consolidated the five cases and granted all five petitioners a stay of execution in November 2021 for review.


In a recent progress report on the PMTA review process, the FDA stated that it has issued MDOs for 46,000 e-cigarette products. Dozens of e-cigarette manufacturers have challenged the refusal orders in federal court.


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

Product|WASPE 60000 Launches in U.S. with 3-in-1 Design and 60,000 Puffs
Product|WASPE 60000 Launches in U.S. with 3-in-1 Design and 60,000 Puffs
The WASPE 60000 disposable vape has launched in the U.S. and Spain, priced at $6.45. Featuring a 3-in-1 design, it offers 60,000 puffs, 12 flavor combinations, and allows users to switch both flavors and nicotine strengths.
May.23 by 2FIRSTS.ai
Over 40% of Teens in Northern Ireland Use E-Cigarettes
Over 40% of Teens in Northern Ireland Use E-Cigarettes
A new study by Northern Ireland’s Public Health Agency (PHA) reveals that over 40% of students aged 17 to 18 currently use e-cigarettes, while 15% of teenagers overall are vaping. The PHA is calling for enhanced health education to help families and educators engage in open conversations with young people and discourage e-cigarette use.
May.16 by 2FIRSTS.ai
PMI Launches IQOS ILUMA i Series in Saudi Arabia to Support a Smoke-Free Future
PMI Launches IQOS ILUMA i Series in Saudi Arabia to Support a Smoke-Free Future
Philip Morris International (PMI) has launched its next-generation heated tobacco products, the IQOS ILUMA i series, in Saudi Arabia, debuting with two devices: ILUMA i PRIME and ILUMA i.
Jul.09 by 2FIRSTS.ai
U.S. Federal Court Orders Vape Website Permanently Shut Down Over Illegal Flavored E-Cigarette Sales
U.S. Federal Court Orders Vape Website Permanently Shut Down Over Illegal Flavored E-Cigarette Sales
New York Long Island e-cigarette company permanently closed by federal court for selling illegal flavored products, facing fines.
May.23 by 2FIRSTS.ai
Malaysia Seizes Over $2.07 Million Worth of Illegal E-Cigarettes, Two Arrested for Unlawful Sales
Malaysia Seizes Over $2.07 Million Worth of Illegal E-Cigarettes, Two Arrested for Unlawful Sales
Malaysia’s General Operations Force seized illegal e-cigarette devices worth over RM8.8 million (approximately $2.07 million) during a special operation, arresting two suspects. The case has been handed over to relevant authorities for further investigation.
Jul.10 by 2FIRSTS.ai
STMA Launches Special Inspection: Shenzhen Vape Companies Face Major License Renewal Test
STMA Launches Special Inspection: Shenzhen Vape Companies Face Major License Renewal Test
Shenzhen office of the State Tobacco Monopoly Administration (STMA) announced the launch of a month-long special inspection targeting local vape companies.
Jun.12