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.

WSJ: White House Pushes for More Flavored Vape Approvals as FDA Commissioner Makary Blocks Move
WSJ: White House Pushes for More Flavored Vape Approvals as FDA Commissioner Makary Blocks Move
According to The Wall Street Journal, the White House is pushing to allow more flavored vape products onto the market for the first time in years, but FDA Commissioner Marty Makary opposes the move and has blocked the plan. The report said a memo from Makary’s office prevented authorization of several flavors from vape maker Glas, even after FDA scientific reviewers had supported them.
Apr.20 by 2FIRSTS.ai
China’s tobacco regulator names Yao Laiying as top leader
China’s tobacco regulator names Yao Laiying as top leader
China’s tobacco regulator has undergone a top leadership change, according to an official announcement on March 20.
Mar.20
Illinois HB 4652 Targets Discarded Vapes, Would Require Manufacturer-Funded Disposal Programs
Illinois HB 4652 Targets Discarded Vapes, Would Require Manufacturer-Funded Disposal Programs
Illinois House Bill 4652 proposes e-cigarette companies establish and fund safe disposal programs to combat environmental risks.
Mar.09 by 2FIRSTS.ai
 Bangladesh Approves Amended Tobacco Control Law Expanding Ad Bans and Smoke-Free Areas
Bangladesh Approves Amended Tobacco Control Law Expanding Ad Bans and Smoke-Free Areas
Bangladesh’s new government has approved a broad tobacco control amendment that bans tobacco advertising, promotion and display across print, electronic, digital and social media, entertainment platforms and points of sale. The law does not cover newer products such as vapes, heated tobacco products, electronic nicotine delivery systems or nicotine pouches.
Apr.22 by 2FIRSTS.ai
Alaska AG warns 1,500+ retailers to stop selling unauthorized vapes and nicotine pouches
Alaska AG warns 1,500+ retailers to stop selling unauthorized vapes and nicotine pouches
Alaska’s attorney general has sent warning letters to more than 1,500 retailers and distributors, cautioning them against selling tobacco products — including e-cigarettes and oral nicotine pouches — that lack U.S. Food and Drug Administration authorization.
Mar.06 by 2FIRSTS.ai
BAT Appoints Constantinescu as CFO,He Previously Spent 16 Years at the Company
BAT Appoints Constantinescu as CFO,He Previously Spent 16 Years at the Company
BAT has appointed Dragos Constantinescu as chief financial officer. Constantinescu, currently head of Asahi Europe & International, will join the company on September 1 and replace Javed Iqbal, who has served as interim finance chief since August last year
Apr.09 by 2FIRSTS.ai