FDA must stop sales of all flavored products and restrict marketing and sales to protect kids

WASHINGTON, DC – According to reports by The Washington Post and other media, the Food and Drug Administration plans to announce limitations on the sale of certain flavored electronic cigarettes in convenience stores and gas stations, restricting the sale of the affected products to tobacco and vape shops. The Post reports that the FDA’s plan would include e-cigarettes that use prefilled flavor cartridges (sometimes called pods), such as the Juul e-cigarettes that have become wildly popular with kids. It would exempt mint and menthol-flavored e-cigarettes, and the restriction would not apply to so-called “open tank” e-cigarette systems.

The Washington Post also reported that FDA Commissioner Scott Gottlieb plans to propose prohibiting menthol cigarettes. Ending the sale of menthol cigarettes is long overdue and is one of the single most important steps the FDA can take to further reduce cigarette smoking and save lives in the United States. The FDA and Commissioner Gottlieb should move forward as quickly as possible to propose, finalize and implement regulations to remove menthol cigarettes from the market. We urge the FDA to issue a concrete timeline for doing so.

E-Cigarettes

It is a positive step that the FDA recognizes the critical role flavors play in the skyrocketing youth use of e-cigarettes and is planning action to reduce the widespread availability of flavored e-cigarettes. But the details will be critical, and the FDA needs to go further. To reverse the epidemic of youth e-cigarette use, the FDA needs to stop the sales of all flavored e-cigarette products that have not been subject to public health review by the FDA as the law requires.

There is nothing to prevent the number of vape shops from rapidly expanding and there is no solid evidence that vape shops do a good job of preventing illegal underage sales. In addition, youth use of e-cigarettes is not limited to Juul and other pod-type products. Even before the introduction of Juul, e-cigarettes had become the most commonly used tobacco product among kids and research found that 81 percent of youth who ever tried e-cigarettes started with a flavored product.

The FDA has reported that youth e-cigarette use increased by more than 75 percent this year and reached “epidemic” levels (the 2018 data is expected to be released soon). The FDA must respond with a comprehensive approach and mandatory regulations that apply to all manufacturers.

In addition to stopping the sale of all flavored products, the FDA should 1) restrict marketing that appeals to kids; 2) prohibit online sales of e-cigarettes until stronger safeguards are in place to prevent sales to kids (The Washington Post reports that the FDA plans to impose age verification requirements for online sales); and 3) enforce current rules prohibiting the sale of new or changed products after August 8, 2016, without prior agency review and reverse its decision allowing e-cigarettes introduced by August 8, 2016, to stay on the market until 2022 without FDA review. This premarket review requirement is one of the FDA’s most important tools to stop the introduction of products that appeal to kids, rather than dealing with them after they have become popular with kids, as in the case of Juul.

The FDA has rightly declared that youth e-cigarette use is a public health crisis. The agency’s proposed actions, as reported, are a positive step forward but not sufficient.

Menthol Cigarettes

We welcome reports that the FDA plans to end the sale of menthol cigarettes and urge the FDA to move forward quickly with finalizing the rule to do so. There is overwhelming scientific evidence that menthol cigarettes have had a profound adverse effect on public health in the United States, resulting in more death and disease from smoking.

Action on menthol cigarettes is long overdue. A comprehensive FDA report on menthol cigarettes, issued in 2013, concluded that menthol cigarettes lead to 1) increased smoking initiation among youth and young adults; 2) greater addiction; and 3) decreased success in quitting smoking. “These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes,” the FDA’s report concluded.

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