Tag: Durbin

  • U.S. Lawmakers Introduce Bill to Require Vapor User Fees

    U.S. Lawmakers Introduce Bill to Require Vapor User Fees

    Six U.S. senators have introduced legislation that would require e-cigarette manufacturers pay user fees to the Food and Drug Administration (FDA) to provide the regulatory agency. The fees would finance additional resources for the FDA to conduct stronger oversight of the e-cigarette industry and increase awareness of the danger of e-cigarettes.

    U.S. Senate Majority Whip Dick Durbin joined U.S. Senators Jeanne Shaheen, Lisa Murkowski, Susan Collins, Tammy Baldwin, and Mitt Romney introduced the Resources to Prevent Youth Vaping Act to protect children from the dangers of e-cigarettes, according to press release from Durbin’s office. Companion legislation will be introduced in the House by U.S. Representatives Cheri Bustos and Brian Fitzpatrick.

    Credit: Larry

    “Big Vape has hooked nearly four million kids on e-cigarettes, creating a vaping epidemic that is threatening our next generation with a lifetime of nicotine addiction and disease,” said Durbin. “The FDA needs to clear the shelves of these dangerous and addictive products, and Congress needs to pass the Resources to Prevent Youth Vaping Act, which will help provide FDA with the resources to better regulate this market.  Enough is enough. The health of our children cannot wait any longer.”

    The Resources to Prevent Youth Vaping Act increases the total amount that will be collected in tobacco user fees by $100 million in Fiscal Year (FY) 2022 and indexes that amount to inflation for future years. The bill also authorizes FDA to collect user fees from all manufacturers of products that have been deemed as tobacco products by FDA, including e-cigarettes, according to Durbin.

    Currently, manufacturers of traditional combustible tobacco products pay into FDA user fees, but e-cigarette companies are exempt due to a loophole in the law. The amount collected from individual e-cigarette manufacturers will be proportional to their share of the overall tobacco market, as determined by FDA. FDA would be able to use this additional revenue from e-cigarette user fees to conduct safety review of vaping products, prevent sales of e-cigarettes to minors, help support efforts to educate youth on the dangers of e-cigarettes and increase the agency’s oversight and enforcement capabilities.  

    Earlier this year, Durbin introduced the bicameral Tobacco Tax Equity Act to reduce youth tobacco use by closing loopholes in the tax code that have long been exploited by the tobacco industry to avoid regulation and taxes for their products. The bill would also apply tax parity across all tobacco products, including establishing the first federal e-cigarette tax and increased the tobacco tax rate for the first time in a decade.

  • Senator Durbin Blasts FDA Over E-Cigarette Oversight

    Senator Durbin Blasts FDA Over E-Cigarette Oversight

    U.S Senate Majority Whip Dick Durbin yesterday testified at a House Oversight and Government Reform Subcommittee on Economic and Consumer Policy hearing that focused on youth vaping and the role of the Food and Drug Administration (FDA) in regulating e-cigarette products.

    During his testimony, Durbin blasted the shortcomings of the FDA’s tobacco oversight over the last several years and urged the agency to rectify its missteps and put public health and the safety of children at the forefront of its mission, according to a press release.

    “Flavored e-cigarette products have exploded in popularity among our kids—nearly four million now vaping, a 361 percent increase in just eight years when only 800,000 kids were vaping,” Durbin said. “Who is the cop on the beat to whom we entrust our children? It’s the Food and Drug Administration. And this agency has been timid and reluctant for way too long.”

    All e-cigarette manufacturers were required to submit Premarket Tobacco Product Applications (PMTAs) to FDA by September 9, 2020, in order to legally stay on the market. FDA is now evaluating those applications based upon a public health framework and is required to complete review by September 9, 2021. FDA’s decisions on the PMTA applications will determine the course of the youth vaping epidemic.

    In his testimony, Durbin urged the FDA to finally apply the public health standard that Congress passed in 2009 under the Tobacco Control Act and evaluate whether a product can stay on the market if it is, “appropriate for the protection of public health.” Durbin said he feared the FDA will over-value the unproven potential benefit of cessation for adult smokers, while under-valuing the clear evidence and experience we’ve had over the past several years on how flavored products hook kids.

    “Only four percent of adults use e-cigarettes [compared] to 20 percent of high-school students. Kids who never would have picked up a tobacco product are vaping. It’s simple: any product with a history of increasing youth use must be rejected by FDA—especially flavored products that we know hooks the kids. This is the Super Bowl for the FDA’s tobacco effort and I’m afraid they aren’t ready for primetime. I hope they prove me wrong,” Durbin said.

    Durbin went on to describe how despite promises from the Trump Administration to crack down on kid-friendly e-cigarette flavors, the FDA still left loopholes that have been exploited by the vaping industry to continue to hook kids onto new and illegal products.

    “The result? Kids migrated…to the products that remained unregulated on the market: menthol flavored e-cigarettes and disposable vaping products. The use of disposable e-cigarettes… which were exempted from FDA’s January 2020 action, increased 1,000 percent last year. Make no mistake: kids get it. If we don’t take this seriously they will find those loopholes continue their addiction,” Durbin said. “And because FDA allowed menthol-flavored cartridges from JUUL and others to stay on the market, their use…increased from 11 percent to 62 percent of the [cartridge] market. Another failure by the FDA.”

  • U.S. Senator Asks FDA to Release List of PMTA Filers

    U.S. Senator Asks FDA to Release List of PMTA Filers

    Dick Durbin
    Credit: Durbin.gov

    U.S. Senator Dick Durbin urged the U.S. Food and Drug Administration (FDA) to strongly enforce its own regulations “to protect kids from addictive e-cigarettes” by publishing a list of products that submitted premarket tobacco product applications (PMTAs). The Illinois senator wants to remove products that did not submit PMTAs from store shelves.

    “After years of delayed regulatory oversight, which fueled the explosion in youth e-cigarette use, FDA finally required e-cigarette PMTAs to be submitted for review on September 9. It has now been more than one month, and the agency has yet to publish a comprehensive list of products that submitted applications,” according to a press release.

    Durbin said he was concerned that the delay to publish the list of products that have submitted applications will allow products that remain out of compliance and illegally on the market to proliferate.

    “In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA. While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” Durbin wrote in a letter to FDA Commissioner Dr. Stephen Hahn.

    Vapor and e-cigarette products can remain on the market while the FDA determines whether to approve or reject PMTA applications. The agency has up to one year to make these determinations.