A bipartisan group of senators led by Senate Majority Whip Dick Durbin, D-Ill., has condemned delays by the Food and Drug Administration to regulate e-cigarettes and take action against companies marketing illegal vaping products, especially to children.
The group, which also includes Republicans Mitt Romney of Utah and Lisa Murkowski of Alaska, sent a letter Wednesday to Health and Human Services Secretary Xavier Becerra drawing attention to the FDA's "repeated failures" in regulating the marketplace.
"We ask you do everything in your power to right the ship and take meaningful action to fix the FDA's persistent leadership failures and prevent youth from a lifetime of nicotine addiction," the senators wrote.
In 2016, the FDA used the Deeming Rule to give itself broad authority over regulating e-cigarette and vaping devices, but the Trump administration in 2017 instructed the FDA to delay its implementation of the rule.
"This delay led to millions of e-cigarettes illegally flooding the market without proper authorization as required under the Tobacco Control Act," the senators wrote. "These delays, coupled with aggressive and misleading advertising — targeted at children and pulled straight from Big Tobacco's playbook — helped to ignite the youth vaping epidemic."
In 2019, U.S. District Court Judge Paul Grimm, a Barack Obama appointee, ruled the FDA exceeded its authority in the delay. Grimm required e-cigarette manufacturers to submit applications for premarket review of their products to the FDA by Sept. 9, 2020, in order to receive permission to keep their products on shelves across the U.S.
The senators wrote the FDA "is still delinquent in this obligation — more than 16 months past the deadline set by the court."
"Last week, the FDA submitted filings disclosing that it will take nearly another year for the FDA to complete its work — until December 31, 2023 — for the e-cigarettes with the largest market share," the letter stated. "We can project from retail sales and public health surveys that approximately one million children are at risk of newly picking up vaping in the intervening time that FDA misses the court order."
The senators claim e-cigarettes continue to be peddled to children as the FDA refuses to "swiftly finalize applications and adequately enforce violations of the law's premarket authorization requirement."
"This is simply unacceptable," the letter stated. "Each day that FDA fails to enforce against products illegally on the market, more children pick up vaping. We need an FDA that stands on the side of public health and our children, rather than becoming mired in delays or cowering to Big Tobacco's lawyers."
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