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.

Product | BAT Japan Launches virto Bright Peach Click in Japan, Expanding glo Hilo’s Capsule-Based Flavor Portfolio
Product | BAT Japan Launches virto Bright Peach Click in Japan, Expanding glo Hilo’s Capsule-Based Flavor Portfolio
British American Tobacco Japan (BAT Japan) has introduced virto Bright Peach Click, a new heated tobacco stick designed for the glo Hilo system. The product expands the existing virto consumable lineup with a combination of tobacco, menthol and ripe peach flavors, featuring a capsule mechanism that releases additional fruit flavor when activated. The product launched in Japan on July 27, 2026, through glo official online channels, convenience stores and tobacco retailers.
Aug.03
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
According to convenience retail publication CStore Decisions, U.S. convenience store tobacco categories are undergoing a structural shift. Based on Circana OmniMarket Total U.S. Convenience data for the 52 weeks ending June 14, 2026, cigarettes remained the largest category with $50.8 billion in sales, but unit sales declined 5.3%. Electronic smoking devices and vaping products also declined, while modern oral nicotine products continued to grow, with nicotine pouch sales rising 29% in dollars and 17% in units. Retailers said changing consumer preferences are reshaping tobacco product assortments at convenience stores.
Regulations
Aug.07
BofA Upgrades Imperial Brands, Says Market Overreacted to Australia Slump
BofA Upgrades Imperial Brands, Says Market Overreacted to Australia Slump
Bank of America upgraded Imperial Brands to “buy” from “neutral,” saying investors have overreacted to the tobacco group’s Australian business downturn and that the share-price pullback has created a more attractive entry point.
Jul.16
South Korea Vape Strategies Diverge as BAT Reconsiders Exit and PMI Takes VEEV to About 14,000 Stores
South Korea Vape Strategies Diverge as BAT Reconsiders Exit and PMI Takes VEEV to About 14,000 Stores
BAT Rothmans says it previously considered exiting South Korea's vaping market because of competitive pressure from unregulated products, but is now reassessing conditions following changes to the country's nicotine regulatory framework. Vuse and other BAT vaping products remain available through existing distribution channels. The statement followed a South Korean media report that interpreted BAT's broader withdrawal from selected Vapour markets as a full exit from South Korea. Meanwhile, Philip Morris International launched VEEV inPRIME in the country in June and began expanding distribution to around 14,000 convenience stores and other retail channels in July. The contrasting moves highlight differing investment strategies as South Korea's regulated vaping market evolves.
Aug.14
Australia’s Tobacco Tax Debate Intensifies as One Nation’s Barnaby Joyce Warns of Illicit Market Growth
Australia’s Tobacco Tax Debate Intensifies as One Nation’s Barnaby Joyce Warns of Illicit Market Growth
Australian One Nation MP Barnaby Joyce has criticised continued tobacco excise increases, arguing that higher taxes are driving consumers toward illicit tobacco markets and benefiting organised crime groups.
Regulations
Jul.13 by 2Firsts Perspectives
FDA Proposes Foreign Tobacco Factory Registration Rule to Tighten Import Oversight
FDA Proposes Foreign Tobacco Factory Registration Rule to Tighten Import Oversight
The FDA has proposed a rule requiring foreign tobacco manufacturers to register facilities and list products before exporting to the U.S. If finalized, the rule could affect overseas OEM/ODM factories, contract manufacturers, specification developers, bulk product makers, and repackaging or relabeling firms. FDA says the proposal would help identify unauthorized imported tobacco products, including e-cigarettes.
Special Report
Jun.26