Collins, Colleagues Secure Omnibus Provision to Close E-Cigarette Loophole, Regulate Synthetic Nicotine

Washington, D.C. – Following a successful bipartisan effort co-led by U.S. Senator Susan Collins (R-ME), a member of the Senate Health Committee, the Fiscal Year 2022 omnibus appropriations package included a provision that will clarify the Food and Drug Administration’s (FDA) ability to regulate products containing synthetic nicotine as tobacco products. The omnibus passed the House and the Senate and now heads to the President’s desk to be signed into law.

The most recent National Youth Tobacco Survey found that more than two million U.S. middle school and high school students used e-cigarettes in 2021. Almost 85 percent of youths using e-cigarettes used flavored products. 

“The use of e-cigarettes by our young people threatens the progress we have made to reduce overall tobacco use. I have heard from teachers across Maine about the issue of vaping in our high schools and middle schools,” said Senator Collins. “Although we have taken important steps that are already making a difference in reducing the rate of youth vaping, more work remains to be done. Our provision will clarify FDA’s ability to regulate synthetic nicotine as a tobacco product, helping to combat this public health crisis and protect the health of our kids.”

Nicotine that can be chemically synthesized in a laboratory—rather than derived from tobacco—arguably fell outside of FDA’s statutory definition of a tobacco product, which contributed to the explosion of youth use of vaping devices. This ambiguity also created a scenario in which e-cigarette manufacturers whose applications were rejected by FDA sought to re-purpose their products with synthetic nicotine to evade regulation and remain on the market. This legislative fix was necessary to close legal loopholes that manufacturers of kid-friendly, flavored e-cigarettes sought to sidestep the FDA, which had the potential to erase recent progress made toward curbing the nationwide youth vaping epidemic.

Earlier this month, Senator Collins led a bipartisan letter with Senators Dick Durbin (D-IL), Tim Kaine (D-VA), Mitt Romney (R-UT), Jeff Merkley (D-OR), Lisa Murkowski (R-AK), Elizabeth Warren (D-MA), and John Cornyn (R-TX) to Senate Majority Leader Chuck Schumer (D-NY) and Senate Minority Leader Mitch McConnell (R-KY), urging them to include this fix in the omnibus appropriations bill.

Last year, Senator Collins co-sponsored bipartisan legislation to protect children from the dangers of e-cigarettes. The Resources to Prevent Youth Vaping Act would require that e-cigarette manufacturers pay user fees to the FDA to help fund more activity at the agency to conduct stronger oversight of the e-cigarette industry and increase awareness of the danger of e-cigarettes.

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