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.

AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
AP Questions FDA Rationale as Glas Fruit-Flavored Vapes Won Authorization Without Added Cessation Benefit
The U.S. Food and Drug Administration (FDA) recently authorized two fruit-flavored vaping products from Glas, but a newly released agency memo shows the products did not demonstrate greater smoking-cessation benefits than tobacco-flavored e-cigarettes. The Associated Press said the findings are likely to raise further questions about the FDA’s regulatory rationale and standards for flavored vaping products.
Jun.12
UK Disposable Vape Ban Marks One Year as Adult Use Falls to 8% and Youth Use to 13%
UK Disposable Vape Ban Marks One Year as Adult Use Falls to 8% and Youth Use to 13%
One year after the UK ban on single-use disposable vapes took effect, YouGov data commissioned by Action on Smoking and Health shows that 13% of 11-17-year-old vapers and 8% of adult vapers now mainly use disposable products.
Jun.18
Product | YOOZ Launches Waker Electronic Shisha Device, Expanding Vape Applications Beyond Portable Devices
Product | YOOZ Launches Waker Electronic Shisha Device, Expanding Vape Applications Beyond Portable Devices
YOOZ has introduced the Waker Electronic Shisha device, expanding its vaping portfolio into the electronic shisha category. The device combines a rechargeable hardware platform with dedicated cartridges, featuring a 4,000mAh battery, up to 60W output power, and LED lighting effects. The product has appeared across multiple French retail channels, reflecting the continued expansion of vaping products into new consumption scenarios.
Jul.13
Malaysia Nicotine Vape Market Faces Legal Uncertainty Over Tax and Poisons List Ruling
Malaysia Nicotine Vape Market Faces Legal Uncertainty Over Tax and Poisons List Ruling
Malaysia’s Finance Minister Anwar Ibrahim said duties and taxes on nicotine-containing vape products will be determined in line with the Court of Appeal’s ruling on whether liquid or gel nicotine can be exempted from the Poisons List under the Poisons Act 1952, a case that could affect the legal basis for vape taxation, retail sales and future ban policy.
Jun.29
UK Vape Brands Face White-Packaging and Flavour-Name Curbs in Youth-Appeal Crackdown
UK Vape Brands Face White-Packaging and Flavour-Name Curbs in Youth-Appeal Crackdown
The UK government and devolved administrations have launched a 12-week consultation on proposals to make vapes less appealing to children, including plain white packaging, limits on device colours, restrictions on flavour names and changes to how products are displayed in shops.
Jul.10
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Pennsylvania’s June 26 ENDS Pending Certifications list previews the state’s future legal vape market, placing Vuse, JUUL and Logic alongside Chinese-linked disposable brands OXBAR and LYCO. Shaped by PMTA eligibility and state rules, the list shows competition shifting from market share to market access.
Special Report
Jul.06