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