"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," Durbin wrote in a letter to Sharpless on Friday.
Durbin asked the FDA to send a letter to all schools warning of the health consequences of vaping, to ban all e-cigarette flavors other than tobacco and to ban e-cigarette devices that the FDA has not cleared and remove them from stores. The FDA has allowed the relatively young e-cigarette market to flourish without any kind of product reviews.
"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," Durbin wrote. "And yet, FDA has refused to act in any type of meaningful way."
The FDA, under former Commissioner Gottlieb, pushed back the deadline to start reviewing e-cigarettes to 2022 from 2018. A U.S. District Court earlier this summer ordered the FDA to start taking applications in 10 months, siding with public health groups who sued the agency for allegedly shirking its legal duties.
Durbin has long criticized the FDA, saying the agency allowed what regulators are calling an "epidemic" of teen vaping. The FDA is under even more pressure amid an outbreak of a mysterious lung disease that is thought to be linked to vaping and has sickened possibly hundreds and killed at least three people.
Durbin asked Sharpless and Mitch Zeller, director of the FDA's Center for Tobacco Products, to schedule a time to brief senators next week on the steps the agency is taking to address vaping-related illnesses and deaths.
The FDA issued the following statement in response to Durbin's letter:
The FDA has been keeping our Congressional colleagues apprised of the ongoing federal and state investigation into these distressing illnesses and deaths following the use of vaping products. We look forward to engaging with Senator Durbin, along with all members of Congress, on this ongoing and very serious situation.
Getting to the bottom of this is a top priority for the agency and all of our federal and state partners. We are all working tirelessly to get as much information as possible about any products or substances used. We are leaving no stone unturned in following any potential leads and we're committed to taking appropriate actions as the facts emerge.
The illnesses under investigation involve the broader use of vaping products — including those being used with substances like THC; e-cigarettes are considered one type of vaping product.
With respect to our work to tackle the youth e-cigarette epidemic, we remain committed to our oversight of e-cigarettes and to keeping them out of the hands of youth. We're aggressively enforcing the law and investing in campaigns to educate youth about the dangers of e-cigarette use. Our educational efforts include youth-focused prevention messages on TV, digital platforms, posters in high school bathrooms, and lesson plans developed with Scholastic for educators.
We'll continue using all of our tools to protect kids, including enforcement actions and penalties. And we've put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we'll take even more aggressive action. We will do what's necessary to end the youth e-cigarette epidemic.