U.S. Representatives Diana DeGette (D-CO) and Debbie Wasserman Schultz (D-FL), along with more than 50 members of the U.S. Congress, wrote a letter in June 2023 calling on the U.S. Food and Drug Administration (FDA) 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. The call comes after FDA failed to meet the initial deadline of September 9, 2021, to complete its review of all pending e-cigarette applications.
In the letter addressed to Robert Califf, MD, FDA commissioner, Congress members requested that the agency:
- Finalize its review of pending applications for e-cigarette products.
- Deny applications for all non-tobacco flavored e-cigarette products.
- Utilize the enforcement tools that have been given to FDA to remove all synthetic nicotine products from the market, including those with pending applications.
FDA indicated in its most recent filings with the court that it will not be able to finalize its review of products with the largest market share until December 2023. 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.
“FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” DeGette said. “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. 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,” Schultz said. “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.”