Romney and Kaine Press FDA on Delay of E-Cigarette Sales Decision, Request Guidance on Menthol Flavors to Protect Youth from Harmful Products

WASHINGTON—U.S. Senators Mitt Romney (R-UT) and Tim Kaine (D-VA), both members of the Senate Health, Education, Labor and Pensions (HELP) Committee, sent a letter to Dr. Janet Woodcock, Acting Commissioner of the Food and Drug Administration (FDA), expressing concern over the FDA’s delay in issuing a decision on whether companies with the largest shares of the e-cigarette market can keep selling their products. In their letter, the senators also call on the FDA to provide clarity on menthol e-cigarettes, which have placed young people at continued risk of exposure to harmful products and dangerous marketing techniques.

“Studies have clearly demonstrated the risk that electronic nicotine delivery system (ENDS) products pose to young people, including increasing the likelihood of future consumption of cigarettes. In response to this risk, your agency was given one year to determine whether these products provided more public health benefit than harm to youth, including whether they were safe for smokers and unappealing to children. Despite reassurances that the FDA would prioritize firms with the largest market share, your agency failed to meet its court-ordered deadline and delayed action on Premarket Tobacco Product Applications (PMTAs) from several companies associated with the youth e-cigarette epidemic,” said the senators.

“Your agency’s failure to issue a timely decision on all PMTA applications and its failure to provide clarity on menthol ENDS products have placed young people at continued risk of exposure to harmful products and dangerous marketing techniques. In fact, in 2020, nearly 20% of high school students and 5% of middle school students reported using e-cigarettes, with mint and menthol flavors being consumed by 56% and 37% of young flavor e-cigarette users, respectively,” continued the senators.

Full text of the letter can be found below:

Dear Commissioner Woodcock,

We write you to express concern about the recent actions taken by the Food and Drug Administration (FDA) regarding electronic nicotine delivery system (ENDS) products. While we applaud the decision to pull more than 5 million of these products from shelves, we are dismayed at the delay in issuing a decision on Premarket Tobacco Product Applications (PMTAs) representing companies with the largest market shares. The FDA has also failed to provide clear guidance on menthol-flavored ENDS products, which make up an increasingly large share of e-cigarette sales. We request a staff briefing and ask that you provide a timeline for issuing decisions on the remaining PMTAs and guidance on the sale of menthol-flavored ENDS products.

Studies have clearly demonstrated the risk that ENDS products pose to young people, including the increasing the likelihood of future consumption of cigarettes.  In response to this risk, your agency was given one year to determine whether these products provided more public health benefit than harm to youth, including whether they were safe for smokers and unappealing to children.  Despite reassurances that the FDA would prioritize firms with the largest market share,  your agency failed to meet its court-ordered deadline and delayed action on PMTAs from several companies associated with the youth e-cigarette epidemic. 

Further, your agency has yet to provide clear guidance on menthol-flavored e-cigarettes. After the FDA’s harmful decision to exclude menthol-flavored e-cigarettes from restrictions on flavoring in 2020,  the sale of these products increased drastically.  In a recent announcement the FDA stated that the scientific review of menthol-flavored ENDS products raised “unique considerations,”   and we are concerned that the FDA will continue to overlook the risk of these products to youth. The recent announcement that the FDA would issue product standards to ban menthol as a characterizing flavor in cigarettes and cigars is a step in the right direction.  The FDA must also take strong action on menthol flavoring in ENDS products in order to curb the youth vaping epidemic.

Your agency’s failure to issue a timely decision on all PMTA applications, and to provide clarity on menthol ENDS products, have placed young people at continued risk of exposure to harmful products and dangerous marketing techniques. In fact, in 2020, nearly 20% of high school students and 5% of middle school students reported using e-cigarettes with mint and menthol flavors being consumed by 56% and 37% of young flavor e-cigarette users, respectively.  To increase transparency on the agency’s progress towards removing these harmful products from the market, we request a staff briefing and a response to the following questions by October 1, 2021:

1. What is FDA’s timeline for issuing decisions on the remaining PMTAs for ENDS products? Please provide an outline of the plan.
2. How does the FDA plan to evaluate the PMTAs for menthol-flavored ENDS products given their harmful impact on youth?
3. How will the FDA ensure that products not authorized for sale are not marketed unlawfully?
    a) In particular, what will you do to enforce the removal of new products on the market without the statutorily required premarket authorization?
    b) How will you ensure the removal of products that received Marketing Denial Orders (MDOs)?

Thank you for your continued efforts to protect youth from harmful ENDS products, and we look forward to your timely response.