Juul's PMTA Application Faces Pressure from Health Groups

Aug.03.2022
Juul's PMTA Application Faces Pressure from Health Groups
FDA's pressure on Juul prompts appeal, but customers are turning to alternative brands.

For several months now, various health and anti-vaping groups have been pressuring the FDA to reject any PMTA applications from Juul. In fact, earlier this year, several groups jointly wrote to the FDA urging it to take action on Juul's PMTA and reject any applications for flavored e-cigarette products.


Last month, the FDA issued a marketing denial order (MDO) to Juul, which applies to all their products currently sold in the United States, and will force the manufacturer to completely exit the US market. "We recognize that many products have played a role in the surge of youth e-cigarette use," said FDA Commissioner Robert M. Califf.


However, in response, Juul immediately filed an emergency motion to the federal appeals court, requesting the court take a stand against the FDA's "unconventional and unlawful actions." A panel of three judges from the United States Court of Appeals for the District of Columbia Circuit ruled in favor of Juul, allowing the product to remain on the market temporarily.


The FDA has responded by temporarily suspending its decision in order to conduct further review. "The FDA is reviewing its marketing denial order to JUUL because, through reviewing briefs filed in litigation, the agency determined that unique scientific issues exist that require additional review," a spokesperson for the FDA told Filter. He added that "the cessation does not change the fact that Juul's product does not have marketing authorization and [the company] cannot legally market, ship or sell their product.


Meanwhile, retailers of electronic cigarettes report that customers have started to shift towards alternative brands. Will Montgomery, a sales representative for Aj's Liquor, emphasized that even if the ban on Juul is implemented, sales of electronic cigarettes will not be affected as consumers will simply switch to different brands. "People still need nicotine," he said.


The ban has prompted consumers to turn to other products or sources.


Ted Egan, chief economist of San Francisco, confirmed that the infamous flavor ban in 2020 only led to increased smoking rates. This supported the argument that the ban could have negative economic impacts.


In a revealing interview published in the San Francisco Chronicle on May 15, Igna explained that the ban would not have an impact on the city's economy, as the money spent on e-cigarette products would still be spent on other nicotine products in the city, such as traditional cigarettes. He went on to explain that consumers would switch products based on availability.


This article is compiled from third-party information for the purpose of industry discussion and learning.


This article does not represent the views of 2FIRSTS and 2FIRSTS is unable to confirm the authenticity and accuracy of the content. The translation of this article is only meant for industry professionals to exchange and study.


Due to limitations in our compilation abilities, the translated article may not fully convey the original message. Please refer to the original article for accuracy.


In regards to any domestic, Hong Kong, Macau, Taiwan, or foreign related statements and positions, 2FIRSTS remains fully aligned with the Chinese government.


The copyright of the 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.

Hawaii Restricts Vape Sales to FDA-Authorized Products, Disposable E-Cigarettes to Be Banned
Hawaii Restricts Vape Sales to FDA-Authorized Products, Disposable E-Cigarettes to Be Banned
Hawaii has enacted two new e-cigarette laws that significantly tighten market access requirements, requiring products to meet FDA authorization standards and banning disposable e-cigarette sales starting in 2027.
Jul.08
Ukrainian Media: Polish Vape Distributor Evapify Allegedly Linked to Russian Businessman Named in U.S. “Russia Oligarch Report”
Ukrainian Media: Polish Vape Distributor Evapify Allegedly Linked to Russian Businessman Named in U.S. “Russia Oligarch Report”
According to an investigative report by Euromaidan Press, a Ukrainian English-language independent media outlet, Russian businessman Oleg Boyko has been sanctioned by Ukraine, Poland, Australia and Canada, but has not been added to the European Union’s sanctions list. The report alleges that Evapify, a Polish vape distributor with financial and personal ties to Boyko, holds a significant position in Poland’s disposable vape market.
News
Jun.01
AHA Journal Study: WS-23 Triples Premature Heartbeats, Raising Concerns Over Vape Cooling Agents
AHA Journal Study: WS-23 Triples Premature Heartbeats, Raising Concerns Over Vape Cooling Agents
A University of Louisville research team published a study in an American Heart Association journal suggesting that synthetic cooling agents used in e-cigarettes, including WS-3 and WS-23, may disrupt cardiac electrical activity and increase arrhythmia risk. In animal experiments, WS-23 tripled premature heartbeats.
Jun.16
UK Vaping Products Duty to Raise £565 Million by 2030/31
UK Vaping Products Duty to Raise £565 Million by 2030/31
The UK will introduce Vaping Products Duty on all vaping liquids from October 1, 2026, with government revenue forecast to rise from £135 million in 2026/27 to £565 million by 2030/31.
Jun.18
Pennsylvania Updates ENDS Certification List as Chinese-Linked Manufacturers Enter State Review
Pennsylvania Updates ENDS Certification List as Chinese-Linked Manufacturers Enter State Review
Pennsylvania’s June 26 Pending ENDS Certifications list includes 23 manufacturers under review, including Shenzhen Smoore, Shenzhen IVPS, YME Technology and China-linked Boulder International. The list shows state-level vape regulation moving beyond retail brands toward manufacturer-based market access alongside FDA oversight.
Regulations
Jul.06 by 2Firsts Perspectives
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
CTT Pharmaceutical Holdings said it has signed a letter of intent with a U.S. company to conduct clinical trials and testing for several potential nicotine products using its patented oral thin-film technology.
Jun.18