The Trump administration on Wednesday announced that FDA intends to finalize a compliance policy that will clear the market of unauthorized, non-tobacco-flavored e-cigarettes, including mint and menthol flavors, in response to growing numbers of children using e-cigarettes.
FDA in 2016 finalized rules that extended the agency's regulatory authority over tobacco products to include e-cigarettes, cigars, pipe tobacco, and water pipe tobacco. The rule imposed retroactive premarket reviews, requiring manufacturers of affected products to receive FDA approval of products that entered the market after Feb. 15, 2007, to continue selling them.
FDA under former Commissioner Scott Gottlieb had planned to give e-cigarette manufacturers until 2021 to submit their products for review. However, U.S. District Court Judge Paul Grimm in May ordered FDA to move up the deadline in response to concerns from public health groups that the products were gaining popularity among teens.
Under the order, e-cigarette makers must file premarket applications by May 12, 2020, for all e-cigarette products that were on the market as of Aug. 8, 2016. Products with an application submitted by that deadline can remain on the market for up to one year from the date of the application's submission while FDA reviews the application. E-cigarette makers that do not file a premarket application by the deadline will face FDA enforcement actions. The order allows FDA to exempt products from the premarket application filing requirements for "good cause" on a case-by-case basis.
However, that deadline is now being challenged in court by the Vapor Technology Association—which represents 800 companies, including Juul Labs—and Vapor Stockroom, which claim the deadline is "arbitrary" and would be "impossible to meet for thousands of small and mid-sized vapor businesses."
Details on FDA's latest plan
HHS in a release said FDA in coming weeks will finalize a new compliance policy that outlines how the agency will enforce premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol.
HHS said the policy would effectively mean that only FDA-approved flavored e-cigarette products would be allowed on the market.
HHS said the policy announcement comes as preliminary numbers from the National Youth Tobacco Survey show a continued increase in the number of children using e-cigarettes, including more than a quarter of high school students. HHS said the survey data shows that the majority of youth e-cigarettes users said they preferred fruit, menthol, or mint flavors of e-cigarettes.
President Trump, who unveiled the plan Wednesday alongside HHS Secretary Alex Azar and acting FDA Commissioner Ned Sharpless, said, "We have a problem in our country. It's a new problem. It's called vaping, especially vaping as it pertains to innocent children." He noted that his administration "may very well have to do something very, very strong about it," adding, "We can't allow people to get sick. And we can't have our kids be so affected."
Sharpless said FDA's new compliance policy "will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use. We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products."
The announcement comes amid rising cases of a severe lung illness that appears to be tied to e-cigarette use and vaping. More than 450 cases of the condition have been reported to CDC as of Sept. 6, and at least six people have died.
Matt Myers, president of the anti-tobacco group Campaign for Tobacco-Free Kids, said FDA's plan is a "long way from the finish line," but added, "if in fact they pull flavored e-cigarettes from the market, it is an extraordinary step in the face of a real crisis."
Sen. Dick Durbin (D-Ill.), who last week told Sharpless to either take "decisive action" against e-cigarettes or resign, in a statement said, "Finally, the FDA is doing its job."
A spokesperson for Juul, which leads the e-cigarette market in the United States, said, "We strongly agree with the need for aggressive category-wide action on flavored products." The spokesperson added that the company "will fully comply with the final FDA policy when effective."
However, Gregory Conley, president of the American Vaping Association, said FDA's planned ban would "remove life-changing options from the market that have been used by several million American adults to quit smoking" (HHS release, 9/11; Kaplan, New York Times, 9/11; Jackson, USA Today, 9/11; Maloney/Leary, Wall Street Journal, 9/11; Wingrove/Fabian, Bloomberg, 9/11; McGinley, Washington Post, 9/11; LaVito, CNBC, 9/11; Jackson, et. al., NBC News, 9/11; Owens, "Vitals," Axios, 9/12).