US FDA Denies Approval to Avail Vapor's E-Cigarette

Dec.13.2022
US FDA Denies Approval to Avail Vapor's E-Cigarette
US regulator rejects e-cigarette maker's product, halting Avail Vapor LLC's entry to American market due to lack of research.

A flavoring e-cigarette company has lost access to the US market. The US Food and Drug Administration denied approval for the company's products to be sold, according to a recent court order that supports strict regulation of the e-cigarette industry by regulatory bodies.


The United States Food and Drug Administration (FDA) has taken action within its jurisdiction to tackle the challenging task of preventing the next generation of Americans from becoming addicted to nicotine and tobacco products. In doing so, it has rejected the claim made by Avail Vapor LLC, a company based in Virginia.


Thompson Hine, the legal representative of Avail, declined to comment on the matter. The U.S. Food and Drug Administration has not yet responded to requests for comment.


E-cigarettes deliver nicotine by evaporating liquid instead of burning tobacco. In 2016, the US Food and Drug Administration established that e-cigarettes are subject to its regulation as traditional tobacco products and allowed manufacturers to apply for approval of e-cigarettes and related products such as liquid by the year 2020.


Avail, a well-known retailer of electronic liquid flavorings, has sought approval for its products in 2020 by telling the FDA that they can help smokers quit by switching to vaping. The company claims to have taken measures, including age verification for online sales and limited distribution through specialty stores, to ensure that its liquids are not sold to minors.


The US Food and Drug Administration rejected the application in 2021, stating that the company failed to provide long-term studies to support the claim that their product flavors, including fruit flavors, are more effective in helping smokers quit than tobacco flavors.


The institution stated that tobacco-flavored e-cigarettes have less appeal to minors and refused to consider the company's plan to restrict sales.


Circuit judge J. Harvie Wilkinson stated that Avail company encourages us to overlook the forest for the trees by focusing on procedural opposition instead of the FDA's duty to protect public health.


The US Food and Drug Administration has rejected applications for over 55,000 e-cigarette products.


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.

The Pittsburgh City Council has introduced new regulations for e-cigarette shops, prohibiting them from being located within 1,500 feet of schools and other places
The Pittsburgh City Council has introduced new regulations for e-cigarette shops, prohibiting them from being located within 1,500 feet of schools and other places
US Pittsburgh City Council proposed a new bill: new e-cig stores can’t be within 1,500ft (≈457.2m) of schools, daycares, religious sites or parks. The restriction only applies to new stores, not existing ones. The bill also bans e-cig stores from operating 11pm-9am next day and requires e-cigs, CBD products, etc., to be stored in locked cabinets.
Sep.22 by 2FIRSTS.ai
Argentina's Neuquén province reiterates e-cigarette ban, covering import, distribution, and marketing
Argentina's Neuquén province reiterates e-cigarette ban, covering import, distribution, and marketing
The Consumer Protection Agency of Neuquén Province, Argentina, reiterated on September 24 that the ban on the import, distribution, marketing and advertising of e-cigarettes, similar devices and related accessories is fully effective. The restriction also covers "heated tobacco products" based on Resolution No. 565/2023 of the Ministry of Health and Regulation No. 3226/2011 of ANMAT.
Sep.25 by 2FIRSTS.ai
Leather Wrap + Mini Display: DOJO’s New Product Launches in the U.S., Priced Around $15
Leather Wrap + Mini Display: DOJO’s New Product Launches in the U.S., Priced Around $15
DOJO lists Sphere S 40K in the U.S.: semi-transparent leather wrap, mini status display; 20 mL/40,000 puffs/1000 mAh, ECO/SMART; $14.99; some pages “Coming Soon.”
Oct.14 by 2FIRSTS.ai
2Firsts Exclusive | AVM President Allison Boughner: The U.S. Vape Market Reshapes Under a Regulatory Storm
2Firsts Exclusive | AVM President Allison Boughner: The U.S. Vape Market Reshapes Under a Regulatory Storm
Amid intensified regulation and sweeping market shifts, the U.S. vaping industry is undergoing a profound transformation. In an exclusive interview with 2Firsts, AVM President Allison Boughner discusses how enforcement is reshaping brands, distribution, products, compliance, and U.S.-based manufacturing.
Oct.20
Russian Lawmaker Sounds Alarm as Teenage Vaping Surges—Female Use Overtakes Male
Russian Lawmaker Sounds Alarm as Teenage Vaping Surges—Female Use Overtakes Male
Russia’s Chair of the State Duma Committee on Youth Policy warns that among 11–14-year-olds, girls now vape at higher rates than boys, a trend he calls “deeply concerning.” He says the spread of nicotine products—especially e-cigarettes—among minors poses a public health risk and warrants continued policy-level interventions.
Oct.17 by 2FIRSTS.ai
Australian Border Force Seizes 586M Cigarettes and 3M Vapes in Record First Quarter
Australian Border Force Seizes 586M Cigarettes and 3M Vapes in Record First Quarter
Australian Border Force (ABF), 586 million cigarettes and over 3 million vapes were seized at Australia’s international border in the first quarter of the 2024–25 financial year (July 1–September 30), marking a continued upward trend over the past two years. Enhanced intelligence and data-sharing have enabled ABF to target suspicious consignments more effectively across all entry points.
Oct.24 by 2FIRSTS.ai