The U.S. Court of Appeals for the D.C. Circuit Denies FDA's Rejection of Fontem's E-Cigarette Application

News by 2FIRSTS.ai
Aug.31.2023
The U.S. Court of Appeals for the D.C. Circuit Denies FDA's Rejection of Fontem's E-Cigarette Application
The US Court of Appeals found that the FDA failed to conduct proper analysis before rejecting some e-cigarette product applications.

According to a report by Vaporvice on August 30th, The U.S. Court of Appeals for the D.C. Circuit yesterday found that the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications.

 

The court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent, but rejected the FDA’s denial of Fontem’s applications for unflavored products.

 

This is the second circuit court of appeals to accuse the FDA of a “surprise switcheroo” when reviewing vaping product applications.

 

Fontem, the company behind the Blu and myBlu vaping brands, argued that the FDA had not conducted the proper analysis prior to rejecting their applications. The D.C. Circuit Court agreed with Fontem in regards to their unflavored products, ruling that the FDA had “neglected to conduct the overall public health review specified by law.”

 

Judge Rao’s opinion for the court (joined by Judge Walker and Senior Judge Ginsburg), stated that with respect to Fontem’s unflavored products, the FDA also denied Fontem’s applications on the public health ground.

 

“While the FDA identified multiple ‘deficiencies,’ it failed to analyze the tradeoffs necessary to make a public health finding. Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health,” the opinion states. “The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”

 

In denying Fontem’s unflavored products, the FDA relies solely on the public health ground. The FDA could have promulgated regulations imposing consistent requirements on the composition and manufacturing of tobacco products, according to the order.

 

“Had the agency done so, Fontem’s failure to meet those standards would be an independent and sufficient ground for denying the applications, regardless of the overall public health consequences of Fontem’s products,” the order states. “But the agency has not exercised its regulatory authority. Because the FDA has chosen to proceed application by application under the public health ground, it must undertake the holistic inquiry required by the statute.”

 

Instead of making an overall assessment that Fontem had not shown its products were beneficial to the public, the agency identified five highly technical deficiencies, according to the order. But nothing in the denial order explains how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.

 

The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the order. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.

 

“Cf. 21 U.S.C. § 387j(c)(3) (providing an application denial “be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form”),” the order states. “But in several instances, the FDA changed its tune in the denial order, reproaching Fontem for failing to provide information the agency had never explicitly sought.

 

“Shifting the regulatory goalposts without explanation is arbitrary and capricious. By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”

 

 

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.

Global Nicotine Gum Market to Reach US$ 2 Billion by 2027
Global Nicotine Gum Market to Reach US$ 2 Billion by 2027
The global nicotine gum market, valued at US$ 1.5 billion in 2021, is projected to reach US$ 2.0 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 5.04% during 2022-2027.
Market
May.26
BIDI Proved More Appealing to Smokers than Non-smokers
BIDI Proved More Appealing to Smokers than Non-smokers
Study finds BIDI Stick vape device more appealing to adult smokers (21+) than non-smokers, suggesting its potential as a cigarette alternative.
Market
Apr.17 by Newswire; Ellesmere Zhu
Let the World Enjoy the Savor of Sichuan - Exclusive with NGP Center of China Tobacco Sichuan
Let the World Enjoy the Savor of Sichuan - Exclusive with NGP Center of China Tobacco Sichuan
On Dec. 18, China Tobacco Sichuan’s new HnB Kung Fu 3.0 made a debut in the famous tourist attraction Kuan Zhai Alley. 2FIRSTS was honored to be invited to the release and made an exclusive interview with the designer team. Dr. Han, head of HTP dept., was confident that the new product will continue to bring the fragrance of Chinese tobacco to the world.
Events
Dec.20
Rise of Gold: E-cigarette Brands Embrace Luxurious Design
Rise of Gold: E-cigarette Brands Embrace Luxurious Design
Golden e-cigarette products gain popularity at the UK e-cigarette exhibition, with brands adopting a "tycoon" style packaging resembling gold bars.
Market
Oct.28 by 2FIRSTS.ai
PMI's Heated Tobacco Products Underperform in Spain
PMI's Heated Tobacco Products Underperform in Spain
PMI's heated tobacco sales fall short in Spain, contributing only 5% of the total revenue.
MarketBusiness
May.16 by Ashe Wong
Vapes Bars Responds to Allegations of Plagiarism by Lost Mary
Vapes Bars Responds to Allegations of Plagiarism by Lost Mary
Vapes Bars, an e-cigarette company, denies allegations of trademark infringement against rival Lost Mary brand.
News
Sep.04 by 2FIRSTS.ai