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.

Canada Faces Growing Debate as Youth Nicotine Pouch Use Reaches 34.8%
Canada Faces Growing Debate as Youth Nicotine Pouch Use Reaches 34.8%
New Canadian research shows that 34.8% of people aged 17 to 27 have tried nicotine pouches, up more than fourfold from 7.6% in 2022. The findings come as Conservative politicians, Alberta’s government and the tobacco industry push Ottawa to relax current restrictions on pouch sales.
Jun.12
How AI Is Rewriting the Talent Playbook for the Nicotine Industry: JTI’s Case
How AI Is Rewriting the Talent Playbook for the Nicotine Industry: JTI’s Case
AI is moving from a back-office tool to a core organizational capability in the nicotine industry. Based on JTI’s responses, this 2Firsts feature examines how AI is reshaping talent strategy, internal mobility, decision-making and human accountability as global tobacco companies compete in the shift toward new nicotine categories.
Jun.17
Imperial Brands Launches 2ml+10ml blu MAX 6000 Vape System
Imperial Brands Launches 2ml+10ml blu MAX 6000 Vape System
mperial Brands has launched blu MAX 6000 in the UK, positioning the product as a higher-puff vape kit with longer-lasting use and replaceable pod+refill options. The device uses a 2ml+10ml click-on box format, with starter kits priced at £10.99 (approximately $14) and replacement pod+refill packs priced at £7.99 (approximately $10).
Market
May.19
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Russian Interior Ministry spokesperson Irina Volk said on May 6 that police in Moscow seized about 65,000 nicotine-containing products from a man during searches of residential and warehouse premises. The products were valued at about RUB 30 million, or about USD 395,727 based on an exchange rate of USD 1 = RUB 75.81.
May.11 by 2FIRSTS.ai
2Firsts Hosts U.S. Compliance Briefing on Building PMTA Support Capabilities Across the Nicotine Supply Chain
2Firsts Hosts U.S. Compliance Briefing on Building PMTA Support Capabilities Across the Nicotine Supply Chain
2Firsts held a U.S. compliance briefing in Shenzhen to help vaping, heated tobacco and nicotine pouch supply chain companies strengthen PMTA support capabilities. The event focused on supplier documentation, quality systems, traceability, TPMF/TPMP pathways, age verification and customer audit readiness as U.S. compliance expectations increasingly extend deeper into the nicotine supply chain.
Events
Jun.12
Vapesourcing Lists RELX Creator Pro 15K as “Coming Soon,” Shows U.S. Warehouse Shipping Options
Vapesourcing Lists RELX Creator Pro 15K as “Coming Soon,” Shows U.S. Warehouse Shipping Options
2Firsts found that U.S.-facing and cross-border vape retailer Vapesourcing has created a product page for the “RELX Creator Pro 15K Disposable Vape Kit 3%,” marked as “Coming Soon.” The page lists U.S. warehouse shipping options, but does not show that the product is currently available for purchase.
Market
Jun.08