FDA Restrictions on Flavored… | Campaign for Tobacco-Free Kids
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FDA Restrictions on Flavored E-Cigarettes Fall Short of What Is Needed to Reverse Youth Epidemic

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
March 13, 2019

WASHINGTON, DC – The restrictions on flavored e-cigarettes announced today by the FDA are a step forward, but they are inadequate to reverse the youth e-cigarette epidemic and fall short of prohibiting the flavors that have made e-cigarettes so popular with kids.

FDA Commissioner Scott Gottlieb deserves credit for focusing attention on this skyrocketing epidemic that is addicting a new generation of kids and threatens decades of progress in reducing youth tobacco use. If today’s action helps reduce youth access to popular e-cigarette flavors, it will be beneficial. But a public health crisis of this magnitude demands faster and more forceful action than the steps announced by the FDA. It is important to note that today’s announcement is a “draft guidance” with no deadline for issuing a final policy or enforcing it. It is also disappointing that the FDA has yet to propose rules to ban all flavored cigars and menthol cigarettes as it promised to do in November.

The FDA’s proposed policy restricts the sale of some flavored e-cigarettes to age-restricted locations, but falls short in several critical respects. It does not apply to menthol and mint flavors despite recent data (from the 2018 National Youth Tobacco Survey, conducted by the FDA and the CDC) showing that over half (51 percent) of high school students who currently use e-cigarettes use menthol or mint products. The FDA inexplicably ignores the evidence from its own survey in exempting mint and menthol flavors from its new policy.

Today’s announcement also does little to limit the availability of Juul or Juul pods that deliver as much nicotine as a pack of 20 cigarettes, despite the fact that Juul is the main driver of the youth e-cigarette epidemic. The Juul device itself and high-nicotine Juul pods in menthol and mint flavors will continue to be widely sold in convenience stores and gas stations accessible to kids. If anything, Juul products are likely to be available in more locations than when the FDA first announced its plan in November because of the new partnership between Altria and Juul.

The FDA also announced that it is moving up by one year, from August 8, 2022, to August 8, 2021, the date by which manufacturers of flavored e-cigarettes have to comply with the law requiring them to submit applications to FDA and undergo a review of their public health impact in order to stay on the market. This is a modest improvement, but falls short of what is needed. The original deadline was August 8, 2018, until the FDA moved it back four years. The new deadline still leaves flavored e-cigarettes on the market for years without having to provide the FDA with any evidence that they have a public health benefit. It also excludes mint- and menthol-flavored e-cigarettes so that applications for those products do not even need to be filed with the FDA for more than three years. (The Campaign for Tobacco-Free Kids and other health groups have sued the FDA, arguing that the FDA’s lengthy delay of these product review deadlines exceeds its legal authority.)

With Juul and other mint- and menthol e-cigarettes still widely available, it is doubtful the FDA’s new policy will stem the tide of youth e-cigarette use. The FDA must do more and do so quickly. It should prohibit all flavored e-cigarettes that have not been subject to public health review by the agency, halt online sales of e-cigarettes until stronger safeguards are in place to prevent sales to kids, restrict marketing that attracts kids, and enforce rules prohibiting the sale of new products without FDA authorization.

There is no time to waste as Commissioner Gottlieb has warned that youth e-cigarette use likely has continued to climb in 2019. This follows a 78 percent increase in e-cigarette use among high school students in 2018, to 20.8 percent of the student population. There is growing evidence that young people who use e-cigarettes are more likely to become smokers, and many of these are low-risk youth who would not have otherwise used cigarettes.

The FDA’s new policy on flavored cigars also falls short of the complete ban that is needed and the FDA has promised. The new policy does not apply to flavored cigars that were on the market as of February 15, 2007 (a date set by law). This leaves a large number of flavored cigars on the market despite FDA’s own conclusion that a far higher percentage of youth, especially African-American youth, use flavored cigars compared to adults. It is disappointing that the FDA failed to issue its promised rule to ban all flavored cigars, which has been pending before the Office of Management and Budget since October 2018.

We are at a critical juncture in the nation’s fight against tobacco, with the youth e-cigarette epidemic threatening the enormous progress we have made. The FDA must do more to reverse this epidemic and also move forward with its bold proposals to further drive down smoking, including banning flavored cigars and menthol cigarettes.