Denver City Wire

WASHINGTON, D.C. – U.S. Reps. Diana DeGette (D-CO) and Debbie Wasserman Schultz (D-FL) led more than 50 members of Congress in calling on the U.S. Food and Drug Administration to abide by a court-ordered deadline to review outstanding Premarket Tobacco Product Applications for e-cigarette products that remain on the market without approval.

In a letter to FDA Commissioner Robert Califf, the lawmakers requested the agency finalize its review of pending applications for e-cigarettes products; deny applications for all non-tobacco flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

The lawmakers’ call comes after FDA failed to meet a court-ordered deadline of September 9, 2021 to complete its review of all pending e-cigarette applications submitted to the agency.  In its most recent filings with the court, FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

“FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said DeGette. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

“Flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use,” said Wasserman Schultz. “When children’s health is at stake, we cannot delay. Unfortunately, the tobacco products that are most popular with kids have already been on the market for several years with observable negative consequences for public health, and I am very disappointed that the FDA still has not finalized reviewing pending applications per the court-ordered deadline, nor has it removed all these illegal products from the shelves. Leaving flavored e-cigarette products widely available without understanding the full impact they have on attracting youth and other non-tobacco users is dangerous and the FDA must swiftly finalize this review process and use all its enforcement tools available to make sure that kids are protected against illegal, kid-friendly products.”

While FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications – including those for products with the largest market share that are most popular with America’s youth, such as: Juul, Reynolds’s Vuse Alto, Smok, and Suorin.

The lawmakers urged the agency to complete its review of all its pending applications no later than December 31, 2023 – without any further delays. And to use its enforcement power to remove flavored e-cigarette products from store shelves as soon as possible.

The letter was endorsed by a wide range of advocacy groups, including the Campaign for Tobacco-Free Kids (TFK), Preventing Tobacco Addiction Foundation/Tobacco 21, American Heart Association (AHA), Parents Against Vaping e-cigarettes (PAVe), and American Lung Association (ALA).

“We applaud Reps. Wasserman Schultz and DeGette and all the signers of this letter for their leadership in urging the FDA to finish its review of e-cigarette marketing applications and clear the market of all flavored e-cigarettes. The evidence is clear that youth e-cigarette use remains a serious public health problem that is driven by flavored products. We cannot afford any more delays by the FDA in taking strong action to end this youth addiction crisis,” said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids.

“Thank you to Representative Wasserman-Schultz, Representative DeGette and other members of Congress for continuing to press FDA Commissioner Calif to move forward on long overdue actions that will reduce youth e-cigarette use. To protect our kids and truly end the youth e-cigarette epidemic, the FDA must swiftly complete its review of e-cigarette marketing applications and deny applications for all flavored e-cigarettes, including menthol-flavored products. It’s past time for the FDA to rigorously enforce its decisions and end the proliferation of illegal flavored e-cigarettes,” said Harold Wimmer, National President and CEO of the American Lung Association.

“Parents Against Vaping E-cigarettes applauds Representative Debbie Wasserman Schultz and Representative Dianna DeGette for demanding that FDA complete the PMTA process no later than December 31, 2023 and that the agency deny authorization for all flavored products. We also join them in demanding answers about the agency’s refusal to use its full enforcement authority and clear the market of all flavored products until then. FDA’s repeated delays and failure to fully regulate millions of flavored e-cigarettes for years, leaving them easily accessible to minors, have had disastrous public-health consequences for our nation's children,” said Meredith Berkman and Dorian Fuhrman, Cofounders of Parents Against Vaping E-cigarettes.

“E-cigarette use among youth remains at highly concerning levels while some of the largest manufacturers continue targeting children with unauthorized and dangerous products,” said Mark Schoeberl, executive vice president of advocacy at the American Heart Association. “We urge the FDA to complete its review of all premarket tobacco applications and ensure products that have received marketing denial orders are removed from the market.”

In addition to DeGette and Wasserman-Schultz, the letter was signed by U.S. Reps. Barragán, Nanette; Beatty, Joyce; Bera, Ami; Blunt Rochester, Lisa; Bonamici, Suzanne; Bowman, Jamaal; Boyle, Brendan; Budzinski, Nikki; Castor, Kathy; Cherfilus-McCormick, Sheila; Chu, Judy; Cleaver, Emanuel; Cohen, Steve; Craig, Angie; Davis, Danny; Dean, Madeleine; DeSaulnier, Mark; Doggett, Lloyd; Frankel, Lois; Garamendi, John; García, Jesús; Gottheimer, Josh; Grijalva, Raúl; Huffman, Jared; Kelly, Robin; Khanna, Ro; Kim, Andy; Krishnamoorthi, Raja; Kuster, Ann; Landsman, Greg; Lee, Barbara; Lieu, Ted; McGovern, James; Meng, Nadler, Jerry; Grace; Norton, Eleanor; Payne, Donald; Pingree, Chellie; Pocan, Mark; Porter, Katie; Raskin, Jamie; Scanlon, Mary; Schakowsky, Janice; Schrier, Kim; Sewell, Terri; Sorensen, Eric; Soto, Darren; Swalwell, Eric; Thompson, Bennie; Tokuda, Jill; Torres, Ritchie; Trone, David; Underwood, Lauren; Vargas, Juan; Watson Coleman, Bonnie

The full letter can be found here.

Original source can be found here