Food and Drug Administration (FDA) finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint. Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.
The FDA said Thursday that it will ban fruit- and mint-flavored products used in e-cigarettes and vaping products while allowing vape shops to sell flavors from tank-based systems.
Under the new rule, which takes effect in 30 days, companies that do not stop the distribution of the sweeter flavors that appeal to kids risk enforcement action, the FDA said. Companies are also at risk of regulatory action if their products target kids or if they fail to take “adequate measures” to prevent access to children. They’ll still be able to sell tobacco and menthol-flavored pods for the adults who use the products to quit smoking.
The flavoring ban does not apply to menthol and tobacco-flavored products. Vaping shops won a concession that will temporarily allow them to sell flavors in stores from tank-based systems, which allow people to mix their own nicotine and vaping juice.
“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally.”Health and Human Services Secretary Alex Azar said in a statement Thursday.
The agency’s decision comes amid a rise in teen e-cigarette use and a deadly lung illness linked to vaping that has taken the lives of 2500 people across 54 states. At the time, officials cited preliminary data from the 2019 National Youth Tobacco Survey showing more than one-quarter of high school students used e-cigarettes in the past 30 days. Most of those underage vapers cited the use of fruit, menthol or mint flavors, the FDA said.
The Trump administration originally announced plans to ban flavored e-cigarettes in September. But soon after that plan was announced in September, the Trump administration appeared to waver, in part out of concern that tough restrictions could alienate some of the president’s supporters. Pro-vaping groups closely aligned with conservative anti-tax lobbyists pushed Trump and his re-election campaign to take a cautious approach, arguing that thousands of jobs in key states could be at stake.
“As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we’re issuing today confirms our commitment to dramatically limit children’s access to certain flavored e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools, and communities.”
“Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery. While we expect that responsible members of the industry will comply with premarket requirements, we’re ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We’ll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary.”FDA Commissioner Stephen M. Hahn, M.D.
The ban has little to do with the vaping-related lung illness, administration officials said Thursday. Azar said the Trump administration sees the lung illness from vaping as a “separate issue” because most people who are sick are thought by public health officials to have smoked THC-based vaping products.
According to the CDC, most lung illness patients have reported vaping THC, the active ingredient in marijuana.
Trump signed a law in December that prohibited the sale of cigarettes, e-cigarettes, cigars, and other tobacco products to people under the age of 21.
The FDA’s new rules represent the U.S. government’s latest step to combat teen vaping.