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.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Special Report|South Korean Lawmaker Queries China Tobacco Regulator Over Synthetic Nicotine as Export-Rule Gaps Emerge
Special Report|South Korean Lawmaker Queries China Tobacco Regulator Over Synthetic Nicotine as Export-Rule Gaps Emerge
A South Korean lawmaker has asked China’s tobacco regulator to clarify rules for e-cigarettes containing synthetic nicotine amid questions over product declarations and possible tax losses. The dispute exposes gaps between Chinese export requirements and destination-market rules, while underscoring the global impact of China’s licensing and traceability policies.
Jul.10
 BAT Bangladesh Cigarette Sales Fall 14%, Q1 Profit Drops 34%
BAT Bangladesh Cigarette Sales Fall 14%, Q1 Profit Drops 34%
British American Tobacco Bangladesh reported a 14% year-on-year decline in cigarette sales volume and a 34% drop in first-quarter profit, highlighting mounting pressure from inflation, taxation, and weakening consumer spending in Bangladesh.
News
May.18
FDA Grants MRTP Orders for 20 ZYN Nicotine Pouches
FDA Grants MRTP Orders for 20 ZYN Nicotine Pouches
The U.S. Food and Drug Administration (FDA) has issued modified risk granted orders to Swedish Match USA for 20 ZYN nicotine pouch products, allowing the already-authorized products to be marketed with a specific claim that using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
Jul.01
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Philip Morris International (PMI) has officially introduced the VEEV One Plus, the next-generation device in its closed-pod vaping lineup. The product is now featured on the official VEEV website in Portugal, bringing hardware upgrades including a new dual-pod storage system, a larger battery, and an updated device design while maintaining compatibility with existing VEEV One pods.
Jul.02
Reuters: Shopify May Ban All Vape Sales This Week Amid Illegal Market Crackdown
Reuters: Shopify May Ban All Vape Sales This Week Amid Illegal Market Crackdown
Reuters reported that Shopify may ban all vape products from its platform as soon as this week, signaling that U.S. enforcement against the illegal vape market is expanding from retailers and importers to e-commerce platforms and payment networks.
MarketBAT
Jun.23 by 2Firsts Perspectives
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam tightens e-cigarette rules. Health Ministry proposes banning production, trade, transport, storage, ads, promotion, sponsorship, and use of e-cigarettes, heated tobacco, and new products. Hanoi also urges residents to report illegal activities, showing enforcement moves from lawmaking to local action.
Jul.08