In another delay that leaves children at risk, FDA tells court it won’t complete review of e-cigarette marketing apps until June 2023

Statement from the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiativeand

WASHINGTON, DC, May 19, 2022 – “In another delay that leaves American children at risk, the FDA has told a federal court that it will not complete its review of marketing applications for the most popular e-cigarette products until June 2023. – almost two years after September 9, 2021, the deadline set by the court to do so. The FDA’s continued delays are unacceptable and detrimental to the children and public health of our country. Every day the FDA fails to act, it allows tobacco companies to continue to target and create addiction for our children with flavored and nicotine-laden e-cigarettes. The FDA has the power and responsibility to end this public health crisis, but again, it does not.

To protect our children and truly end the youth e-cigarette epidemic, the FDA must quickly complete its review of e-cigarette marketing applications and deny applications for all flavored e-cigarettes, including flavored products. menthol, given the clear evidence that flavored products have fueled youth consumption. If the FDA cannot complete these reviews by the end of June 2022, it should pull all unauthorized products from the market until it completes its reviews.

“In a court-ordered status report filed last week, the FDA said it would not complete its review of marketing applications for major e-cigarette brands until June 30, 2023, and would not complete reviewing only 56% of these applications by the end. This means that some of the most popular youth brands – including flavored products that have driven the e-cigarette epidemic among young people – could stay on the market for another year without the FDA’s public statements that it would prioritize reviewing applications for products with the largest market share, and they undermine the intent of the court order to prevent e-cigarette products — especially those appealing to children — from remaining on the market without FDA review.District Court Judge Paul W. Grimm said on 15 april l, when he ordered the FDA to file quarterly status reports, “popular products used by young people remain on the market without review, which is consistent with the purpose of the Court’s ruling.

“This is the latest in a long line of regulatory delays by the FDA that has allowed e-cigarettes — including thousands of flavored products that appeal to kids — to remain on the market for years without review. nor FDA clearance and to set the stage for young people. In response to these delays and following a successful lawsuit filed by our organizations, Judge Grimm has set September 9, 2020 as the deadline for manufacturers to e-cigarette companies submit marketing applications to the FDA and have cleared products with the applications in a timely manner to remain on the market for up to one year while the FDA reviews the applications – a period that ended on September 9, 2021. All unauthorized e-cigarette products are now subject to enforcement action by the FDA to remove them from the market.

“Eight months after this court-ordered deadline, the FDA has yet to complete its review of marketing applications for electronic cigarettes. Although the FDA’s denial of marketing applications for more than one million flavored e-cigarette products is a positive step, the FDA has yet to issue rulings on many e-cigarette brands that hold the largest market share or are most commonly used by young people. is still considering allowing menthol flavored e-cigarettes despite clear evidence that menthol products are widely used by children.

“To protect our children, the FDA must immediately deny marketing applications for all flavored e-cigarettes – including menthol-flavored products. Youth e-cigarette use remains a serious public health concern in the United States. United States, with the 2021 Tobacco Survey (NYTS 2021) showing that more than 2 million middle and high school students use e-cigarettes Flavored products boosted youth use, 85% of young users of e-cigarettes reporting using flavored products It is also clear that menthol is According to NYTS 2021, nearly 30% of young people who use flavored e-cigarettes reported using menthol-flavored products, including 46% of young people who use flavored cartridge products FDA completes review of e-cigarette marketing applications and frees the market for all flavored e-cigarettes, our children will remain at risk. »

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Arielle Beer: 202.785.7902; [email protected]

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