Vaping News · U.S.

U.S. FDA Authorizes Vuse Solo, the First E-Cigarette Approved for Sale

H HNB Home2021-10-13Views 261Source HNB Home

After rejecting more than 1 million e-cigarette-related products, the U.S. Food and Drug Administration announced that it had authorized the first e-cigarette for sale: Vuse Solo, made by British American Tobacco. The FDA approved the company’s tobacco-fl

After rejecting over 1 million e-cigarette-related products, the U.S. Food and Drug Administration (FDA) today announced that it has authorized the first e-cigarette—Vuse Solo, manufactured by British American Tobacco. The FDA approved the company's tobacco-flavored pods but rejected other flavored pods. After a year-long crackdown on e-cigarettes that ended in September this year, the FDA began to allow these e-cigarette companies to continue selling their products. However, the agency stated that any new tobacco products need authorization to be sold. Currently, any products sold without authorization are illegal.

VUSE SOLO

Companies submitted applications for 6.5 million e-cigarette products, and the agency either rejected the vast majority of applications or deemed them incomplete. The FDA stated that its decision focused on whether the benefits of e-cigarette products for adult smokers—who might use them to quit smoking—outweigh the risks of introducing nicotine to children and adolescents.

The tobacco-flavored Vuse e-cigarette is the first product that the FDA has deemed to meet this standard. According to the 2021 National Youth Tobacco Survey, about 10% of high school smokers use Vuse products. However, the agency stated that the likelihood of youth using tobacco flavors is lower. The FDA rejected 10 flavors of Vuse pods and is still reviewing its menthol flavor application.

The agency also stated that it is limiting R.J. Reynolds Vapor Company's advertising around its e-cigarettes to reduce the likelihood of youth seeing the ads.

This is undoubtedly great news for the industry, releasing two key messages:

1. The PMTA will become the compliance threshold for subsequent e-cigarette products entering the U.S. market, and PMTA will also serve as a reference for other countries and regions in formulating vaping regulations.

Although many e-cigarette companies have applied for PMTA, some companies have taken a wait-and-see approach, believing that PMTA will be more lenient like European policies. However, Vuse's approval through PMTA, along with a series of actions from the FDA, indicates that PMTA is a necessary threshold for those wanting to legally enter the U.S. market. The strictness and scientific basis of PMTA will serve as a reference for other countries and regions in formulating regulatory policies.

2. The trend of tobacco-flavored e-cigarettes continues to strengthen, which may also influence domestic trends, so e-liquid and e-cigarette manufacturers should prepare to abandon flavored e-cigarettes accordingly.

E-cigarettes are harm-reduction alternatives to traditional tobacco. As this view becomes more widely accepted, along with clearer regulatory trends, many e-liquid and e-cigarette companies are developing and focusing on launching tobacco-flavored e-liquids. The FDA's announcement also highlights this trend.

Tags:U.S.FDA

HNB Editorial Team

HNB Home focuses on heated tobacco and vaping industry coverage, including product reviews, brand information, and global market updates.

Related Articles

Ahead of a Nationwide Ban, Hundreds of Russian Retailers Voluntarily Stop Selling Vapes

Illegal Vape Brands Try to Evade FDA Scrutiny by Posing as “Made in the USA”

Jordan’s New Tobacco Control Rules: Waterpipe Tobacco Market Set for Major Changes