Yesterday (Jan. 2), the Food and Drug Administration (FDA) announced a new policy to crack down on companies that sell mint- and fruit-flavored electronic cigarettes, popular products among children and teens.
The policy aims to quell the widespread use of e-cigarettes among U.S. minors, because this use places millions of young people at risk of nicotine addiction, abnormal brain development and the use of conventional cigarettes later in life, according to a statement from the agency. For now, the crackdown will not affect the sale of tobacco- or menthol-flavored products, as research suggests that young users are far more attracted to fruit and mint flavors.
"Our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring [that] these products don't provide an on-ramp to nicotine addiction for our youth," Alex Azar, the secretary of the Department of Health and Human Services, said in the FDA statement.
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The FDA announcement follows an outbreak of vaping-related illness connected to contaminated e-cigarette products. But even if minors get their hands on untainted e-cigarette products, the devices still pose significant risks to their health, the FDA warned. The agency has called vaping among minors an "epidemic," as more than 5 million middle and high school students use e-cigarettes nationwide, according to the 2019 National Youth Tobacco Survey. Of these, 1.6 million minors report using e-cigarettes at least 20 days out of every month while about 1 million say they use e-cigarettes daily.
"We will not stand idly by as this crisis among America's youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary," Azar said.
The new FDA policy does not ban the sale of flavored e-cigarettes. Instead, the agency will now prioritize the removal of "illegally marketed" fruit- and mint-flavored products from the market. To be deemed "legal," products that fall under the Tobacco Control Act, including e-cigarettes and other "electronic nicotine delivery systems," must undergo an FDA review.
This science-based evaluation determines whether the product poses unacceptable risks to public health and weighs whether e-cigarettes make it more likely that people who do not use tobacco products will start using them. Although the act dictates that all e-cigarettes must undergo this review, the agency has delayed enforcing the policy for several years. To date, no existing e-cigarette products have undergone the approval process, and therefore, no product is considered "legally marketed" by the FDA.
The agency could subject any e-cigarette product to enforcement of the act at any time. The new policy simply states that mint- and fruit-flavored e-cigarettes will be the first to face scrutiny.
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The FDA also plans to target products for which the "manufacturer has failed to take … adequate measures to prevent minors' access" through the use of age-verification technology and other sales restrictions. The agency will focus on cartridge-based e-cigarettes, as minors commonly use these products, according to the 2019 Monitoring the Future survey.
Starting May 12, 2020, the FDA will take action against all manufacturers who continue to sell e-cigarettes without first submitting the required premarket application. This action will affect all kinds of e-cigarettes, flavored or otherwise.
"While we expect that responsible members of industry will comply with premarket requirements, we're ready to take action against any unauthorized e-cigarette products as outlined in our priorities," FDA Commissioner Stephen Hahn said in the FDA statement. "We'll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary."
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Originally published on Live Science.
