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.

UK Local Council Proposes £5 Refundable Deposit on Vape Devices
UK Local Council Proposes £5 Refundable Deposit on Vape Devices
Norwich City Council is set to debate a proposed vape deposit scheme that would require consumers to pay an extra refundable £5 per device at purchase, with the money returned when the device is handed back, as recent recycling-facility fires, including a major Widnes blaze reportedly very likely caused by a vape, draw greater attention to the risks of improperly discarded lithium-battery devices.
Jul.01
FDA Tobacco Proposal Signals Full-Chain Compliance Test for Global E-Cigarette Supply Chains
FDA Tobacco Proposal Signals Full-Chain Compliance Test for Global E-Cigarette Supply Chains
FDA’s proposed foreign tobacco establishment registration and product listing rule remains unfinished, but Accorto told 2Firsts it reflects a shift toward structured oversight similar to medical device and pharmaceutical compliance frameworks. For Chinese and global e-cigarette suppliers, U.S. market access is moving beyond product authorization toward full-chain compliance covering manufacturing, documentation, import control, distribution, retail and marketing discipline.
Special Report
Jul.09
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
UK HMRC Urges Public to Report Suspicious Vape Shops in Crackdown on Tax Fraud, Money Laundering and Illicit Tobacco Sales
HM Revenue & Customs is urging members of the public to report vape shops, barber shops and other high-street businesses suspected of tax fraud, money laundering or other illegal activity, with informants not required to provide personal details. HMRC plans more than 30,000 interventions in 2026-27 targeting tax fraud, organised crime and illicit activity, including the sale of illegal vapes and tobacco. The push forms part of a broader UK effort to tackle organised crime on high streets, backed by a £30 million government enforcement programme.
Regulations
Aug.17 by 2Firsts Perspectives
UK HMRC Plans 30,000 Retail Enforcement Actions as Illegal Tobacco and Vape Sellers Face Tougher Crackdown
UK HMRC Plans 30,000 Retail Enforcement Actions as Illegal Tobacco and Vape Sellers Face Tougher Crackdown
The UK government has announced that HM Revenue & Customs (HMRC) will carry out more than 30,000 interventions targeting businesses and retail premises during the 2026-2027 financial year. The actions will focus on tax fraud, illegal goods sales and businesses involved in unlawful activities through retail channels. The government said illegal tobacco and illegal vape sales remain areas of concern. The move shows that UK enforcement against illegal nicotine products is expanding from import and supply channels toward retail-level oversight, alongside the upcoming introduction of the Vaping Products Duty.
Jul.24
BAT Restructuring to Affect 9,000 Roles as Tobacco Group Pushes Cost Cuts and AI
BAT Restructuring to Affect 9,000 Roles as Tobacco Group Pushes Cost Cuts and AI
British American Tobacco (BAT) plans to cut about 5,500 jobs globally and shift around 3,500 roles to strategic partners by the end of 2026, affecting about 9,000 roles in total, as the company seeks to simplify operations, strengthen technology capabilities and deliver £600 million in annual savings by 2028.
BAT
Jun.29
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