(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Maggie Hassan (D-NH), along with 15 other bipartisan Senators, urged Commissioner of the Food and Drug Administration (FDA) Dr. Stephen Hahn to comply with the agency’s requirements to reject e-cigarette applications that do not protect the public health, upon the FDA’s May 12 deadline for e-cigarette product review. The Senators, in a letter sent to Commissioner Hahn yesterday, highlighted concerns with FDA’s ongoing lax oversight of e-cigarettes and tobacco products, and pressed the agency for a science-based review that holds the industry accountable for products that are responsible for fueling the youth e-cigarette epidemic.
“As head of the FDA, your responsibility is to the American public, including, and most important, our nation’s children,” the Senators wrote. “As you know, five million children are now vaping, including one in four high school students—an increase of 135 percent over the past two years alone … we do not believe that a product that has increased or is likely to increase youth use of nicotine or tobacco can meet the public health standard required under the [law].”
The Senators also urged FDA to act quickly and decisively to remove from the market all tobacco products that are out of compliance with its January 2 guidance or the May 12 deadline, including products that do not submit premarket tobacco product applications (PMTAs), flavored cartridge-based products, and products that appeal to or are targeted to minors.
“When looking at the changing e-cigarette marketplace, including the proliferation of products that use nicotine salts, JUUL-like products, and disposable flavored products, it is virtually certain that many products have entered illegally. FDA will have failed to uphold its responsibility to protect public health if the May 12 deadline is enforced in the same manner as the deeming rule,” the Senators continued.
On May 12, due only to a court order, all e-cigarette manufacturers will be required to submit product applications to the FDA in order to be allowed on the market. If an e-cigarette company wants to keep or put any new device or flavor product onto the market, they must submit an application to the FDA, including for products recently banned (such as certain flavored JUUL pods). E-cigarette products can remain on the market while FDA determines whether to approve or reject their applications. FDA has one year to make these determinations.
The Family Smoking Prevention and Tobacco Control Act (TCA) prohibits any new tobacco products, including e-cigarettes, from entering the U.S. market unless the FDA determines that there is “a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”
Full text of the letter is available here.
Senator Shaheen has prioritized efforts in the Senate to tackle the youth vaping crisis. Over the past year, she and Senator Hassan have repeatedly pressed the Trump administration to remove flavored e-cigarettes from the market and stop delaying action in implementing the planned restrictions on flavored products. Last month, Shaheen led a bipartisan group of Senators in introducing the Resources to Prevent Youth Vaping Act, which would require that e-cigarette manufacturers pay user fees to the FDA to help to fund more activity at the agency to conduct stronger oversight of the e-cigarette industry and increase awareness for the danger of e-cigarettes. She’s also held multiple meetings with students, educators, law enforcement and health officials across the state about the ongoing public health concern. In September, Shaheen introduced the No Tax Subsidies for E-Cigarette and Tobacco Ads Act, which would close a tax loophole that allows manufacturers to claim federal tax deductions for the cost of advertising e-cigarettes and tobacco products. Shaheen also helped introduce the E-Cigarette Device Standards Act, which would set safety standards in the design of e-cigarette and vaping devices to prevent the use of e-cigarettes to vape Tetrahydrocannabinol (THC)—a combination that has been linked to the vast majority of vaping illnesses.
As a member of the Senate Health, Education, Labor, and Pensions Committee, Senator Hassan has also led efforts to address youth e-cigarette use. In the nomination hearing for new FDA Commissioner Dr. Hahn, Senator Hassan pressed him on putting science ahead of politics and corporate special interests, especially when it comes to the opioid crisis and youth e-cigarette use. She also called for the public disclosure of all meetings between FDA and Juul, as well as any data FDA receives from companies like Juul related to youth e-cigarette use. Senator Hassan also helped to promote National Prescription Drug Take Back Day, highlighting the leadership of Manchester students in ensuring that vaping devices and accessories could be accepted.