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The Food and Drug Administration has cleared Juul Labs to continue selling its vaping device and cartridges with nicotine, three years after moving to ban them, the government said on July 17.
The FDA said in a statement that it authorized Juul to market five e-cigarette products, including its vaping device and cartridges.
“Following an extensive scientific review, the FDA determined that evidence provided by the company—including new information the company submitted in response to a deficiency letter from the FDA—demonstrates that these specific products meet the legal standard set by the 2009 Family Smoking Prevention and Tobacco Control Act to market new tobacco products in the United States,” the agency said.
E-cigarettes, also known as vapes and vape pens, are battery-powered devices that heat up liquid in cartridges, turning it into a vapor. The cartridges often contain nicotine, an addictive drug, but do not contain tobacco.
The information included data showing that high numbers of adults switched from cigarettes to Juul products.
“While today’s actions permit these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,’” the FDA stated. “There is no safe tobacco product. Those who do not currently use tobacco products should not start. Youth should never use tobacco products.”
The FDA, which has now authorized 39 e-cigarette products, banned all of Juul’s products in 2022 over what regulators described as insufficient evidence on toxicology.
After a court blocked the ban, the FDA suspended its order, allowing Juul to market its products as the FDA review took place.
Juul officials celebrated the authorization on Thursday.
“This is good news for the millions of Americans who still smoke cigarettes,” the company said in a statement. “While more than two million Americans have switched completely away from combustible tobacco using Juul, we’re focused on making the cigarette obsolete.”
Some research has indicated that e-cigarettes from Juul and other manufacturers lead to similar health problems as experienced with cigarette smoking, and the Centers for Disease Control and Prevention says the aerosol from e-cigarettes can contain harmful substances, although Juul says its products can prevent smoking-related chronic diseases and premature deaths.
The FDA’s authorization was panned by some, including Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids.
“To protect kids, the FDA should deny marketing applications for flavored e-cigarettes and, along with other federal agencies, step up enforcement efforts against the many illegal products currently on the market,” she said in a statement.
Richardson noted that Juul settled thousands of lawsuits accusing it of marketing to teenagers. Juul said at the time it is focused on adult users.
