FDA Denies Marketing Approval for 6,500 Flavored E-cigarettes

Regulations by Ashe Wong
May.15.2023
FDA Denies Marketing Approval for 6,500 Flavored E-cigarettes
The FDA has issued marketing denial orders to 10 companies, affecting approximately 6,500 flavored e-cigarette products.

On May 12, the Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to 10 e-cigarette companies that manufacture and market an estimated 6,500 flavored e-liquid and e-cigarette products. The FDA's decision means these products can no longer be marketed or distributed in the U.S, with retailers risking enforcement action if they continue to sell these items.

 

The stated reason was that the companies' premarket tobacco product applications (PMTAs) did not provide sufficient evidence to demonstrate that the marketing of these flavored e-cigarette products would benefit public health. The FDA denied applications for various products with flavors including Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.

 

The move is part of the FDA's ongoing review of over 26 million new tobacco product applications received since Spring 2020, most of which are for e-cigarette products. The FDA has now taken action on over 99% of these applications.

 

Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products, emphasized that today's denial was based on the lack of scientific evidence provided in the applications. He reiterated the FDA's commitment to ensure all new tobacco products undergo a rigorous, science-based premarket evaluation to assess their public health impact.

 

The FDA's public health standard requires an evaluation of the risks and benefits of a product on the population as a whole. The applicants failed to demonstrate an added benefit to adult smokers from these flavored products that could outweigh the known and substantial risk to youth, leading to denial orders.

 

Companies that received MDOs include:

Imperial Vapors LLC

Savage Enterprises

Big Time Vapes

SWT Global Supply Inc.

Great Lakes Vapor

DNA Enterprise LLC dba Mech Sauce

Absolute Vapor Inc.

ECBlend LLC 

 

The names of the other two companies were not disclosed to protect potential confidential commercial information.


Thumbnail source: tobacco reporter

*The content of this article is written after the extraction, compilation and integration of multiple information for exchange and learning purposes. The copyright of the summary information still belongs to the original article and its author. If any infringement is found, please contact us to delete it. 

HK Legislator Questions HK's Choice of Dongguan Over Shenzhen to Transship E-cigs
HK Legislator Questions HK's Choice of Dongguan Over Shenzhen to Transship E-cigs
The government representative proposed to open the sea-air trans-shipment (from Dongguan) in early 2023 at the HK LegCo on Nov. 28. Legislators expressed dissatisfaction and questioned why the representatives did not mention air-road transit (from Shenzhen). The legislators called for the early enactment of a bill on air-road intermodal transport in relation to Hong Kong's status as an international transport center.
Regulations
Dec.05
BAT Appoints Soraya Benchikh as New CFO
BAT Appoints Soraya Benchikh as New CFO
BAT appoints Soraya Benchikh as new CFO, replacing Tadeu Marroco, aiming to push tobacco business towards alternative products.
Business
Nov.03 by 2FIRSTS.ai
PMI Introduces Tobacco-Free Pod for IQOS Heating Device
PMI Introduces Tobacco-Free Pod for IQOS Heating Device
Philip Morris International (PMI) has announced a tobacco-free pod product designed to be used with its IQOS device.
BusinessPMI
Sep.30 by 2FIRSTS.ai
Police Seize Over 800 Illegal Vapes in Scotland
Police Seize Over 800 Illegal Vapes in Scotland
Scottish police seize over 800 illegal vapes in crackdown on sales of e-cigarettes.
RegulationsNews
May.26 by 2FIRSTS.ai
Misleading Marketing Practices in Email Notice by BAT Subsidiary
Misleading Marketing Practices in Email Notice by BAT Subsidiary
BAT's subsidiary, Reynolds, is accused of engaging in unfair competition by sending misleading emails to distributors.
Regulations
Sep.26 by Zheng Mingwei
Indonesian Customs Indicated That Indonesia Will Still Adjust the Tax Policy of E-Cigarettes
Indonesian Customs Indicated That Indonesia Will Still Adjust the Tax Policy of E-Cigarettes
In an exclusive interview, Mr Nirwala, director of Communication and Stakeholder’s Compliance of Directorate General of Customs and Excise, said that Indonesia will distinguish between ordinary cigarettes and e-cigarettes from this year.
Industry Insight
Oct.22 by 2FIRSTS