October 29, 2019

Amid Delay, Senator Kaine Urges Trump Administration To Prioritize Children’s Health And Keep Promise To Ban Flavored E-Cigarettes

In a letter to HHS Secretary Alex Azar, Democrats condemn the ongoing delay and reported weakening of Trump Administration’s promised action to address epidemic of youth e-cigarette use

WASHINGTON, D.C. – Today, U.S. Senator Tim Kaine joined Senator Patty Murray, ranking member of the Senate Committee on Health, Education, Labor, and Pensions (HELP), and 24 of their Senate colleagues in sending a letter to Secretary of Health and Human Services Alex Azar denouncing the Administration’s delay in issuing a final compliance policy to better address the growing epidemic of youth e-cigarette use. The senators urged the Food and Drug Administration (FDA) to finalize its promised compliance policy and clear the market of unauthorized, flavored e-cigarette products, including mint and menthol flavors.

In the past year, e-cigarette use has increased by more than 75 percent among high school students, largely fueled by the appeal of products with flavors like candy, fruit, mint, and menthol. Nearly two-thirds of youth that use e-cigarettes use mint and menthol products. Though the Trump Administration has promised to address the epidemic, the FDA has yet to finalize the compliance policy on flavored e-cigarettes and is even reportedly considering exempting mint and menthol flavors, despite its promise to include them in the compliance policy. As delays persist, children continue to be drawn to flavored e-cigarettes.

“Because of the ever-increasing epidemic of youth e-cigarette use that has been fueled by flavors that include mint and menthol, we implore the Administration to finalize a compliance policy removing all unauthorized, non-tobacco flavored e-cigarettes from the market immediately,” wrote the senators. “It must not bow to industry or political pressure at the expense of the public health.”

In addition to Senators Kaine and Murray, the letter was also signed by Senators Schumer, Whitehouse, Hassan, Leahy, Brown, Reed, Blumenthal, Shaheen, Markey, Warren, Durbin, Cardin, Murphy, Harris, Klobuchar, Duckworth, King, Merkley, Casey, Van Hollen, Booker, Wyden, Menendez, and Hirono.

Kaine has a long track record of promoting public health and battling tobacco use. Earlier this year, he introduced the Tobacco-Free Youth Actbipartisan legislation to raise the nationwide minimum age to buy all tobacco products from 18 to 21. The bill passed the Senate Health, Education, Labor, and Pensions (HELP) Committee in June. Over the past few months, Kaine has held roundtables in Arlington, Harrisonburg, and Henrico to discuss efforts to address the epidemic of youth e-cigarette use. As Governor of Virginia, Kaine signed a bill into law to ban smoking in bars and restaurants in the Commonwealth, as well as an executive order to ban smoking in state buildings and vehicles. In April 2018, Kaine joined two letters to the U.S. Food and Drug Administration (FDA) and JUUL Labs, Inc. raising concerns about youth access and use of flavored e-cigarettes. In the letter to the FDA, Kaine and his colleagues urged the agency to take immediate steps to ban kid-friendly flavorings that are used in e-cigarettes and cigars. In the letter to Juul Labs, Inc., Kaine and his colleagues asked a series of questions about how the product is marketed to children and teens and what ingredients are in the flavorings that accompany these devices. They requested that the company take a series of important steps to limit youth use of their product.

Full text of the letter is below and the PDF is HERE.

 

October 29, 2019

 

The Honorable Alex M. Azar II                    

Secretary         

U.S. Department of Health and Human Services      

200 Independence Avenue, SW

Washington, DC 20201

 

Dear Secretary Azar,          

We write with significant concerns about the continued delay by the Trump Administration in issuing a compliance policy to address the terrible epidemic of e-cigarette use among children. After years of delay and inaction, which fueled this epidemic, the Trump Administration announced on September 11, 2019, that the U.S. Food and Drug Administration (FDA) intended to “finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco flavored e-cigarette products.”[1] We have long advocated for this action and were encouraged that the Administration had finally decided to act. As of today, however, the FDA has neither finalized nor announced when it will finalize the compliance policy and is reportedly considering significantly weakening this policy by exempting mint and menthol products, which your agency’s own data have demonstrated are incredibly popular among children.[2] While the Administration continues to permit the sale of unauthorized, non-tobacco flavored e-cigarette products, each day more children are becoming e-cigarette users – driven primarily by flavors.[3] We strongly urge the Administration to fulfill its promise to clear the market of all unauthorized, non-tobacco flavored e-cigarettes – including mint and menthol flavors – immediately. 

It is imperative that the Administration promptly finalize the compliance policy. E-cigarette use among children continues to rise at an alarming rate. Approximately 20 percent of high school students reported using e-cigarettes in 2018, which is more than a 75 percent increase in use from 2017.[4] Furthermore, high school students who used e-cigarettes reported using them more often in 2018 than in 2017. E-cigarette use among middle school students increased nearly 50 percent from 2017 to 2018.[5] This appetite for e-cigarette use by children has been largely fueled by the appeal of non-tobacco flavors such as fruit, candy, and menthol or mint.[6] There are no recent signs that e-cigarette use by children is decreasing: preliminary data from the 2019 National Youth Tobacco Survey shows a continued rise in youth e-cigarette use.[7]

Although the full scope of the dangers remains uncertain, it is well-known that e-cigarettes pose a serious health risk to youth. On October 11, 2018, the Washington Post published an op-ed by you and then-FDA Commissioner Scott Gottlieb. In it, you acknowledged that “the steps we have taken thus far are not enough,” noting that e-cigarettes have been the most popular nicotine product among American teenagers since 2014; nicotine is highly addictive and can harm brain development; and children who start on e-cigarettes are more likely than non-smoking peers to end up using traditional tobacco products.[8] You stated you were “actively reconsidering our policy under which certain e-cigarettes — particularly the products with flavors that might appeal to children — can remain on the market ….”[9] In the year since, the epidemic has worsened, and we have learned that e-cigarettes are associated with a nationwide outbreak of lung illnesses, some of which have resulted in death.

On September 11, 2019, you joined President Trump, First Lady Melania Trump, and Acting FDA Commissioner Norman Sharpless in the Oval Office to announce your intent to finalize the compliance policy removing unauthorized, non-tobacco flavored e-cigarettes from the market.[10] You stated the Administration’s intent to “clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” and Acting Commissioner Sharpless noted that “finalization of the compliance policy will be an important step in ongoing work to ensure e-cigarettes are not marketed to, sold to, or used by kids.”[11]

With each day, more children continue to be lured to e-cigarettes by flavors such as fruit, candy, and mint or menthol. We are therefore deeply troubled that there is no final compliance policy more than six weeks after the Oval Office announcement. Instead, the FDA provides assurances that the agency is working “as quickly as possible” to finalize a compliance policy.[12] It is increasingly unclear what the FDA’s final compliance policy will look like.

The Trump Administration is reportedly considering allowing mint and menthol flavors to remain on the market even if and when the FDA does finalize a compliance policy, despite nearly two-thirds of kids who use e-cigarettes using mint and menthol flavored products.[13] This is unacceptable. The Administration has already delayed action for far too long to address this public health crisis.

Further fueling our concerns, on October 25, 2019, news reports indicated that this reconsideration follows warnings from President Trump’s campaign manager, Brad Parscale, that a policy removing flavored e-cigarettes from the market “could backfire in the 2020 election” and that “Trump supporters who use e-cigarettes could abandon the president if he follows through on a ban.”[14] We are outraged that the President appears to be playing politics with children’s health.

Because of the ever-increasing epidemic of youth e-cigarette use that has been fueled by flavors that include mint and menthol, we implore the Administration to finalize a compliance policy removing all unauthorized, non-tobacco flavored e-cigarettes from the market immediately. It must not bow to industry or political pressure at the expense of the public health. If you have any questions regarding this letter, please contact Andi Lipstein Fristedt with the HELP Committee Staff at (202) 224-7675.

Sincerely,

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