FDA authorizes an e-cigarette for first time, citing benefit for smokers

Federal health regulators Tuesday for the first time authorized the legal marketing of an electronic cigarette, saying the product from RJ Reynolds could help addicted adult smokers.

The Food and Drug Administration (FDA) said the company’s refillable Vuse Solo closed device and tobacco-flavored e-liquid pods could benefit addicted adult smokers who switch by reducing their exposure to harmful chemicals.

The first-of-its-kind authorization comes amid an effort by the FDA to regulate the massive vaping industry and determine which products are allowed to stay on the market. 

It signals the agency may look more favorably on tobacco-flavored products than the fruity ones that are most popular among teenagers, even though some feature extremely high nicotine content.

Rep. Raja Krishnamoorthi (D-Ill.), a frequent critic of the vaping industry and the FDA’s efforts at regulation, said the agency failed in its public health responsibility.

“FDA has turned its back on public health by approving a high-nicotine e-cigarette. Many countries around the world have capped the amount of nicotine allowed in e-cigarettes, which allowed them to avoid a youth vaping epidemic,” Krishnamoorthi said in a statement. 

The Campaign for Tobacco Free Kids, Vuse Solo has three times the nicotine concentration as legally permitted in Canada, the UK and Europe.

Electronic cigarettes were first introduced on the market as a “healthier” alternative to smoking traditional tobacco cigarettes, but it began to spread to young people, who were drawn in by sweet and fruit-flavored e-cigarette pods easily accessible in stores. Since 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth. 

Last year, the Trump administration banned popular cartridge-based fruit and mint flavors but not tobacco and menthol. Manufacturers were allowed to submit those products for the agency’s permission to resume their sales. 

The agency missed a court-ordered deadline last month to decide which e-cigarette products can stay on the market.

In the run-up to the deadline, FDA said it made decisions on more than 90 percent of the new tobacco products that were submitted, rejecting applications of more than 300 companies to sell more than 6 million products, mainly due to their potential appeal to underage teens. 

But regulators delayed making decisions on most of the major vaping companies, including Vuse and market leader Juul. 

According to the FDA, the evidence submitted by RJ Reynolds showed established cigarette users preferred tobacco, compared to non-tobacco flavors like mint, nectar, and tropical.

The agency said it considered risks to youth, especially since the 2021 National Youth Tobacco Survey found approximately 10 percent of high school students named Vuse as their usual brand.

But the agency said young people are less likely to start using tobacco-flavored e-cigarettes and then switch to higher-risk products, such as combusted cigarettes. 

FDA also imposed strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising.

The agency said it rejected 10 additional requests from RJR for flavored products submitted under the Vuse Solo brand, but was not publicly disclosing the specific flavors due to confidentiality issues. 

FDA is still reviewing the company’s application for a menthol-flavored product. 

“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.