Trump Administration Seeks to Rid Market of Flavored e-Cigarettes

The Trump administration said Wednesday that the FDA will “prioritize” enforcement of flavored e-cigarette regulations in an effort to get them removed from the market.

“The FDA plans to share more on the specific details of the plan and its implementation soon,” read the statement.

The statement was released after President Donald Trump told reporters in the Oval Office that his administration was going to ban all nontobacco flavors, including mint and menthol, in the wake of hundreds of cases of severe respiratory illnesses across the country and at least 6 deaths. He was joined by HHS Secretary Alex Azar and Melania Trump, as well as Acting FDA Commissioner Ned Sharpless, MD, according to the Associated Press.

Previously, the FDA, under its former commissioner Scott Gottlieb, MD, had threatened to take the products off the market. But Gottlieb decided he did not want to go so far that adults who are trying to quit combustible cigarettes discover the electronic devices are too hard to find. The FDA focused on trying to force retailers to sell certain flavors of e-cigarettes in age-restricted sections of retail stores.

But amid an epidemic of children and teenagers vaping, municipalities and states have begun to take matters into their own hands. Michigan became the first state to prohibit the sale of flavored e-cigarettes, and New York Governor Andrew Cuomo also called for a ban. San Francisco approved an e-cigarette ban earlier this year.

The FDA and the CDC has reported a 78% increase in current e-cigarette use by high school students and a 48% increase among middle school students from 2017 to 2018. Mint and menthol are among the most popular types of e-cigarettes, health officials have said.

On Twitter after the announcement, Azar said, “New provisional data show that youth use continues to rise rapidly, and we will not stand idly by.” He also said that “if data show kids migrating to tobacco-flavored products, we will do what’s necessary to tackle continued youth use of these products.”

The FDA, in a statement, elaborated, saying that “preliminary numbers from the National Youth Tobacco Survey show a continued rise in the disturbing rates of youth e-cigarette use, especially through the use of non-tobacco flavors that appeal to kids. In particular, the preliminary data show that more than a quarter of high school students were current (past 30 day) e-cigarette users in 2019 and the overwhelming majority of youth e-cigarette users cited the use of popular fruit and menthol or mint flavors.”

In response, the Campaign for Tobacco-Free Kids said the move “is a necessary and long-overdue step to address the epidemic of youth e-cigarette use in the United States, but it must be comprehensive, immediate and long-lasting.”

“This is a public health crisis and we cannot afford more delays in confronting it,” said Matthew L. Myers, president of the organization, which had previously been critical of Gottlieb and the FDA, saying their previous efforts did not go far enough. “It has taken far too long to stop Juul and other e-cigarette companies from targeting our nation’s kids with sweet-flavored, nicotine-loaded products that are addicting a new generation and threaten decades of progress in reducing youth tobacco use. We will work to support a comprehensive prohibition on flavored e-cigarettes, and we urge the Administration not to back down in the face of the inevitable pressure from Juul and other manufacturers.”

Currently, e-cigarettes, along with vapes, vaporizers, vape pens, hookah pens, are considered electronic nicotine delivery systems (ENDS), or noncombustible tobacco products. In March, shortly before he resigned, Gottlieb proposed changes to premarket authorization review requirements for flavored ENDS products but exempted products that were flavored with tobacco, mint, or menthol. In order to remain on the market, companies were to submit premarket applications by August 8, 2021, instead of in August 2022. Public health critics said that did not go far enough, and also criticized the agency for not including mint and menthol in the change as well.

On Wednesday, the FDA said, “ENDS products currently on the market are not being legally marketed and are subject to government action. The compliance policy the FDA anticipates announcing in the coming weeks will outline enforcement policy addressing non-tobacco-flavored e-cigarette products that lack premarket authorization moving forward.”

Bloomberg reported that the flavored products would have to be removed from the market within 30 days; however, e-cig makers would be able to apply to the FDA to resume sales if they can prove that the "benefit of its product outweighs the risk, including the potential for underage vapers to pick up the habit."