09.06.19

Durbin To Acting FDA Commissioner: Take Decisive Action To Stop The Vaping Epidemic Or Resign

CHICAGO – Following the death of a third person related to a mystery respiratory illness linked to vaping, U.S. Senate Democratic Whip Dick Durbin (D-IL) today called on U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Ned Sharpless to take decisive action within the next ten days to properly regulate e-cigarettes and the accompanying kid-friendly flavors and products.  In the letter, Durbin said that should Acting Commissioner Sharpless fail to act within ten days, Durbin will call for his resignation. 

“As Acting Commissioner of the FDA, you alone have the power to stop this vaping epidemic, which has now reached the point where children and young adults are getting sick and dying. It is my strong belief that, if you do not take decisive action within the next ten days, you should resign your post,” Durbin said.  “If you continue to refuse to do your job—which is to protect the public health—then it is time to allow someone else to take the helm.”

In today’s letter, Durbin also called for Acting Commissioner Sharpless to send a letter to all schools in America warning of the health consequences associated with vaping, and asking each school to ensure this message is conveyed to parents and students alike; immediately ban all e-cigarette flavors other than tobacco; and immediately ban all e-cigarette devices that have not been approved for sale by the FDA, and ensure their immediate removal from stores nationwide.

Durbin also asked that Senators immediately be briefed on what steps FDA is taking to combat this public health crisis, including what role marijuana-derived products are playing in this epidemic.

To date, the Centers for Disease Control and Prevention (CDC) has reported 450 cases of severe respiratory illness among people using e-cigarettes in 33 states, as well as three deaths (in Illinois, Oregon, and Indiana).  A fourth death is being currently investigated.

To date, Illinois has 42 confirmed cases of vaping-related lung illness, and one death, across 17 different counties, with 26 more cases being investigated as probable.  The median age of vaping-related illness in Illinois is 22 years old.  And 76 percent of the Illinois patients needed to be placed in an intensive care unit (ICU), and 41 percent of the patients were mechanically ventilated.

Over the past year alone, America has seen a 78 percent increase in the number of high-school children using e-cigarettes, and a 48 percent increase in the number of middle-school children using these addictive and dangerous products.  Today, nearly four million children are vaping.

In March, Durbin, along with Senator Lisa Murkowski (R-AK), and U.S. Representatives Diana DeGette (D-CO-01) and Jamie Raskin (D-MD-08), reintroduced bipartisan, bicameral legislation to crack down on kid-friendly flavorings in highly-addictive e-cigarettes and cigars.  The Stopping Appealing Flavors in E-Cigarettes for Kids (SAFE Kids) Act will place strong restrictions on e-cigarette flavorings and ban cigar flavorings altogether.

Full text of the letter is available here and below:

 

September 6, 2019

Dear Acting Commissioner Sharpless:

Our nation is in the midst of a public health crisis that could have been avoided if the Food and Drug Administration (FDA) had acted at any point over the past ten years to properly regulate e-cigarettes and the accompanying kid-friendly flavors and products. To date, the Centers for Disease Control and Prevention (CDC) has reported 450 cases of severe respiratory illness among people using e-cigarettes in 33 states, as well as three deaths (including one in my home state of Illinois). As Acting Commissioner of the FDA, you alone have the power to stop this vaping epidemic, which has now reached the point where children and young adults are getting sick and dying. It is my strong belief that, if you do not take decisive action within the next ten days, you should resign your post. If you continue to refuse to do your job—which is to protect the public health—then it is time to allow someone else to take the helm.

Among some of the decisive actions that you should initiate immediately to combat this vaping-related epidemic, I request that FDA:

1)      Send a letter to all schools in America warning of the health consequences associated with vaping, and asking each school to ensure this message is conveyed to parents and students alike;

2)       Immediately ban all e-cigarette flavors other than tobacco; and

3)      Immediately ban all e-cigarette devices that have not been approved for sale by the FDA, and ensure their immediate removal from stores nationwide.

Further, it is imperative that Senators immediately be briefed on what steps FDA is taking to combat this public health crisis, including what role marijuana-derived products are playing in this epidemic. Therefore, I request that you and Mitch Zeller (Director, Center for Tobacco Products) schedule a time next week to come in and brief any interested Senators on the steps FDA is taking to address and reduce vaping-related illnesses and deaths.

Make no mistake, we saw this storm coming. For years, I have joined with public health groups to warn FDA about the dangers associated with vaping—including sounding the alarm about the skyrocketing rates of youth use of these dangerous and addictive products; bringing to your attention studies which indicate that underage users of e-cigarettes often transition to combustible cigarettes, which kill 480,000 Americans every year; screaming from the rooftop about the role that kid-friendly flavors—such as fruit medley, mint, cookies ‘n cream, sugar cookie, citra zing, whipped cream, and gummy bear—play in enticing and hooking young people on e-cigarettes; and repeatedly voicing skepticism at Big Vape’s completely unsubstantiated claim that these products are safe and effective at helping adult smokers quit cigarettes.

I have expressed these concerns to you on multiple occasions—in person, on phone calls, and in letters—as well as to your predecessor, Dr. Scott Gottlieb. And yet, FDA has refused to act in any type of meaningful way. If FDA had exercised its authority—granted to you by congress ten years ago—we would not be in this situation today. Many of these e-cigarette devices and flavors would not be on the market, countless numbers of children would not now be addicted to nicotine, regulations would be in place to help prevent against the adulteration of e-cigarette devices, and we would have far better information about the short- and long-term health consequences of vaping.

I look forward to your immediate response to this letter. Thank you.

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