11.01.19

SCHUMER: FLAVORED E-CIG BAN IS UNDER REVIEW RIGHT NOW BUT COULD INCLUDE MAJOR LOOPHOLE, LEAVING SOME KID FRIENDLY FLAVORS ON THE MARKET; STANDING WITH DUTCHESS COUNTY KIDS, SENATOR DEMANDS FEDS INCLUDE THESE FLAVORS & IMMEDIATELY FINALIZE THE BAN

Schumer Has Long Pushed For A Ban On Flavored E-Cigs That Trap Kids And Hook Them Fast With Dangerous Levels Of Nicotine; But Now, Ban Being Baked By Feds Could Allow For Some Flavors To Remain On The Market 

With Young People All-Out Addicted To Flavors, Schumer Says Close Loophole Now & Finalize the Rule ASAP

Schumer: Feds Can’t Go Vanilla On Flavor Ban If They Want It To Actually Work

Just as the Trump administration bakes a ban on flavored e-cigarettes, U.S. Senator Charles E, Schumer today sounded the alarm on potential exceptions. Schumer cited reports that the Trump administration is considering allowing a few flavors, such as mint and menthol, to remain on the market even if and when the Food and Drug Administration (FDA) finalizes a compliance policy that would prohibit the sale of all unauthorized, non-tobacco flavored e-cigarette products. Schumer demanded the FDA do this right the first time and not make any exceptions for flavors.

“There is no doubt that as the FDA worked to finalize a ban on kid-friendly e-cigs that the agency was met with intense pressure by the industry to water it down as much as possible, so the message to the administration today is: do not cave,” said Senator Schumer. “If we are going to tackle the all-out epidemic of youth vaping and the flavor explosion fueling addiction and related health issues, the feds cannot go vanilla on a flavor ban. They have to get it right the first time, treating all of these flavors the same, and not picking and choosing at them like children with Halloween candy. And that means including mint and menthol in the flavor ban so companies can’t escape the intent of the policy and bring us right back to square one months down the road."

“All of us—parents, teachers, school administrators, and our community members -- need to be vigilant when it comes to educating young people on the devastating health effects that most certainly come with using vaping devices,” said Dr. Brendan Lyons, Superintendent of Arlington Central School District. “Our district will continue to share valuable information with our students and their families to help combat the use of these addictive devices. The health and safety of our students will continue to be the top priority for the Arlington Central School District.  I am thankful Senator Schumer is taking a stand at the federal level to end the youth vaping epidemic.”

Even though the forthcoming FDA compliance policy was announced on September 11, 2019, it has faced significant delays and has yet to be revealed in full. Schumer says that even though the policy is currently being reviewed, no one knows for sure if the ban will actually apply to mint and menthol flavors. However, given the rapid increase in e-cigarette popularity, Schumer said that the feds need to act quickly. According to the Centers for Disease Control and Prevention (CDC), the overall proportion of high school students that use e-cigarettes doubled from 11.7 percent to 20.8 percent between 2017 and 2018. This means that there were a staggering 1.5 million more youth e-cigarette users in 2018 than in 2017. Last year, the rate of overall tobacco use among high school students jumped from 19.6 percent to 27.1 percent, an increase of 7.5 percent that is largely attributed to e-cigarette use. According to a recent Dutchess County Youth Development survey, only 30 percent of students view e-cigarettes as risky whereas 70 percent of students perceive daily cigarette smoking as very risky. Further, just 16 percent of 12th graders see vaping as risky.

As Schumer advocated for putting an end to the proliferation of appealing e-cigarettes flavors on the market, he also mentioned that the short and long-term health effects of e-cigarette use are still unclear. With this in mind, Schumer said that our youth cannot be subjected to a potential lifetime of nicotine addiction without knowing the full consequences of using these devices. Schumer referenced the ongoing outbreak of lung injuries associated with e-cigarette use, which has resulted in the hospitalization of over 150 New Yorkers due to vaporizer use in recent months. Furthermore, the CDC has confirmed 37 deaths from e-cigarette use, spread across 24 states. To date, the agency has reported at least 1,888 cases of lung injury associated with e-cigarette use from 49 states, the District of Columbia, and one U.S. territory.

Schumer said that these statistics and the uncertainty surrounding the administration’s pending compliance policy demonstrate a pressing need to address the e-cigarette epidemic with full force, using an all-hands-on-deck and all-of-the-above approach. As part of Schumer’s plan, first, he urged the Department of Health and Human Services to swiftly implement the e-cigarette compliance policy, and for the administration to include mint and menthol flavors in the ban. Schumer, joined by over 25 of his Democratic colleagues, said that it is imperative for the Trump administration to finalize the compliance policy in order to protect our youth from the serious health risks attributed to e-cigarettes.

Second, Schumer called on his colleagues in Congress to expediently pass the bipartisan Stopping Appealing Flavors in E-Cigarettes for Kids (SAFE Kids) Act. The legislation, which is cosponsored by Senator Schumer, was introduced by Senators Dick Durbin (D-IL) and Lisa Murkowski (R-AK) in the Senate and has a House companion. Specifically, the bill would ensure that all e-cigarette flavors, including mint and menthol, are pulled from the market. Schumer said that by advertising these and other types of flavors, companies are clearly directing their efforts toward ensnaring children and getting them hooked on their products, and that they must be stopped without further delay. The legislation contains a provision that would allow for the reintroduction of certain flavors back to the marketplace, but only if companies prove, beyond a shadow of a doubt, that their products: help adults stop smoking traditional cigarettes, do not increase the rates of youth tobacco and nicotine use, and do not increase the likelihood of a user falling ill. According to a recent Sienna Poll, 78% of New Yorkers think e-cigarette use and vaping are serious problems and a large majority (61%) support a ban on flavors.

E-cigarettes are battery-operated devices that are designed to resemble traditional cigarettes. E-cigarettes contain a mechanism inside the device that heats up liquid nicotine and transforms it into a vapor that users then inhale and exhale. Unlike conventional cigarettes, however, e-cigarettes do not contain tobacco, a key difference that has led some to deem e-cigarettes safer to smoke. Yet, not all health risks are known, and some studies have highlighted the dangers of e-cigarettes. For example, a study published in the New England Journal of Medicine found that some higher voltage e-cigarettes can contain cancer-causing formaldehyde at levels up to fifteen times more than regular cigarettes. In addition, e-cigarettes contain nicotine, a chemical that has been shown to have negative health impacts on adolescent brain development.

Earlier this year, Schumer was successful in a push to get the outgoing FDA Commissioner to take action on kid-friendly flavors domestically.

A copy of Schumer’s letter to HHS appears below.

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.”  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.  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.  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.  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.  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.  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.  

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.  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 ….”  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.  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.”  

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.  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.  This is unacceptable. The Administration has already delayed action for far too long to address this public health crisis.

Further fueling our conerns, 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.”  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.

Sincerely,

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