DALLAS, September 9, 2022 — Following is a statement from the American Heart Association, the world’s leading voluntary organization focused on heart and brain health:

“One year after a court-ordered deadline to determine whether flavored e-cigarette and cigar products should be authorized for sale, the FDA has yet to rule on the premarket applications for some of the most popular brands on the market. The FDA’s inaction is allowing tobacco companies to continue targeting youth and under-resourced communities with unauthorized products that have fueled an epidemic of nicotine addiction.

“The FDA had until Sept. 9, 2021 to rule on premarket tobacco applications for e-cigarettes and flavored cigars that were submitted to the agency by Sept. 9 of the previous year. Although the agency has issued decisions on thousands of applications, many applications for products with significant market share are still pending. It is unacceptable that the FDA, a year after the court-ordered deadline, has indicated it may take until next summer to rule on the remaining applications. It is also unacceptable that some products whose applications were denied by the agency continue to be sold.

“It is imperative that the FDA both complete its review of all premarket tobacco applications and ensure products that have received marketing denial orders are removed from the market.

“The need for FDA action on premarket tobacco applications extends to synthetic nicotine products. Under congressional legislation signed into law earlier this year, synthetic nicotine products that have not received premarket authorization from the FDA cannot be legally marketed as of July 13, 2022. However, thousands of synthetic nicotine products continue to be sold even though the FDA has not authorized any of them.

“These highly addictive products, which are sold in fruit, candy and mint flavors that appeal to youth, pose an active and ongoing threat to public health. The FDA should immediately order these products to be pulled from the market while they undergo agency review, and remove products that failed to submit an application by the May 14 deadline.”

Note: The Sept. 9, 2021 deadline for ruling on premarket tobacco applications for e-cigarettes, cigars and other new tobacco products stemmed from a 2018 lawsuit challenging an FDA decision to delay the requirement that manufacturers of new tobacco products demonstrate to the FDA that their products are ‘appropriate for the protection of the public health.’ The FDA had sought to delay the application deadline until August 2022, leaving these products on the market without FDA review and authorization, but a federal court struck down this FDA action. The lawsuit was filed by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual pediatricians.


About the American Heart Association
The American Heart Association is a relentless force for a world of longer, healthier lives. We are dedicated to ensuring equitable health in all communities. Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public’s health and share lifesaving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us on heart.orgFacebookTwitter or by calling 1-800-AHA-USA1

For Media Inquiries:

Steve Weiss: 202-607-0911; steve.weiss@heart.org

Arielle Beer: 202-785-7902; arielle.beer@heart.org

For Public Inquiries: 1-800-AHA-USA1 (242-8721)

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