Shaheen Urges FDA to Protect Children as It Reviews E-Cigarette Applications

January 14, 2021

(Washington, DC) – U.S. Senator Jeanne Shaheen (D-NH) and a bipartisan group of 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, as part of the FDA’s long-overdue product review for e-cigarettes that began in September. In their letter to Commissioner Hahn, the Senators highlighted the high standard the Family Smoking Prevention and Tobacco Control Act (TCA) sets for authorizing premarket tobacco product applications (PMTAs), and urged the agency to conduct a science-based review that holds industry accountable for products that are fueling the youth e-cigarette epidemic. The Senators also provided a list of principles for the FDA to use as it reviews PMTAs, including to implement the statutory requirement by rejecting applications unless the manufacturer can prove the product does not lead to youth tobacco initiation and will reduce the risk of harm. U.S. Senator Dick Durbin (D-IL) led the letter.

“For years, delays by FDA to enforce the premarket review requirements of the TCA for all new tobacco products enabled thousands of products to be marketed without undergoing a scientific review by FDA, including a wide array of flavored, high-nicotine e-cigarettes targeted to youth.  If implemented properly, the long-overdue PMTA review can protect public health and halt our nation’s epidemic of youth e-cigarette use,” the Senators wrote.

The 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.”

The full text of the letter is available here.

Senator Shaheen has prioritized efforts in the Senate to tackle the youth vaping crisis. She has repeatedly pressed the Trump administration to remove flavored e-cigarettes from the market, stop delaying action in implementing the planned restrictions on flavored products and hold e-cigarette companies accountable. 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 on the danger of e-cigarettes. She’s also held multiple meetings with studentseducatorslaw enforcement and health officials across the state about the ongoing public health concern. Shaheen also 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 is a supporter of 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. Following troubling reports on the potential increased risk that vaping poses for COVID-19 infection, Shaheen and a group of Senators urged the administration to better inform the public about potential risks, while also mitigating those risks through action to reduce use of these products among young people.