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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Dutch Data Show 244 Companies Continued Illegal Vape Sales After Two Fines
Dutch Data Show 244 Companies Continued Illegal Vape Sales After Two Fines
According to RTL Nieuws, citing figures from the Netherlands Food and Consumer Product Safety Authority (NVWA), hundreds of Dutch shops continue to sell illegal vapes, often even after repeated fines.
Apr.08 by 2FIRSTS.ai
Australian Government and Spotify Launch Third Phase of Youth Vaping Education Campaign
Australian Government and Spotify Launch Third Phase of Youth Vaping Education Campaign
The Australian Government and Spotify have launched the third phase of the Youth Vaping Education Campaign under the theme “Buddy Up – Make a Pact to Quit Together.” This phase shifts the focus toward peer and community support by encouraging young people to quit vaping together.
Apr.16 by 2FIRSTS.ai
Belgian Health Minister Calls Tobacco Industry “Criminal” After Court Undermines Supermarket Sales Ban
Belgian Health Minister Calls Tobacco Industry “Criminal” After Court Undermines Supermarket Sales Ban
Belgian Health Minister Frank Vandenbroucke described the tobacco industry as a “criminal” sector with “no future” during an appearance on VRT’s current affairs program Ter Zake. His comments came after Belgium’s Constitutional Court ruled that a government ban on cigarette and vape sales in supermarkets was discriminatory because it allowed small shops to sell tobacco products while prohibiting larger retailers from doing so.
May.07 by 2FIRSTS.ai
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
FDA Says It Will Not Take Enforcement Action Against Zone Nicotine Pouches Until Lawsuit Is Resolved
The U.S. Food and Drug Administration has told vape manufacturer Fontem US that it does not presently intend to take enforcement action against the company’s Zone nicotine pouches while litigation over the agency’s handling of the application remains unresolved.
Apr.07 by 2FIRSTS.ai
Argentina’s New Nicotine Rules Draw Cautious Optimism and Market Concerns, Local Tobacco Harm Reduction Advocate Says
Argentina’s New Nicotine Rules Draw Cautious Optimism and Market Concerns, Local Tobacco Harm Reduction Advocate Says
Argentina’s new tobacco and nicotine framework marks a shift from prohibition toward registration, traceability and health surveillance. Argentine THR advocate Juan Facundo Teme told 2Firsts that adult consumers and parts of the local commercial sector are cautiously optimistic, but concerns remain over flavor limits, registration costs and market access. The policy’s implementation may determine whether Argentina can move informal sales into regulated channels.
May.11
Revised Tobacco Business Act to Take Effect in South Korea, Banning Online Sales of Liquid Vapes
Revised Tobacco Business Act to Take Effect in South Korea, Banning Online Sales of Liquid Vapes
South Korea’s Ministry of Health and Welfare will implement a partial revision of the Tobacco Business Act on April 24. The scope will expand from products made with “tobacco leaves” to all products manufactured with natural or synthetic nicotine. Synthetic nicotine liquid e-cigarettes, which had previously been treated as industrial products and were freely sold and advertised online, will from April 24 be subject to the same regulations as ordinary tobacco products.
Apr.23 by 2FIRSTS.ai