FDA Won’t Finish Reviewing E-Cigarette Marketing Applications Until June 2023

August 09, 2022 by Alec Stone MA, MPA, ONS Government Affairs Director

E-cigarette marketing application reviews won’t conclude until June 2023, the U.S. Food and Drug Administration (FDA) said in a status report (https://www.tobaccofreekids.org/assets/content/what_we_do/federal_issues/fda/2022_05_13_fdastatusreport.pdf) in May 2022, sparking frustration among healthcare advocates.

U.S. Senator Dick Durbin (D-IL) and a collective group of healthcare advocacy organizations—including the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Campaign for Tobacco-Free Kids and Truth Initiative—released statements in May 2022 voicing disappointment about this delay.

“These companies have flooded the market with addictive devices,” Durbin said (https://www.durbin.senate.gov/newsroom/press-releases/durbin-im-calling-on-fda-to-immediately-halt-its-enforcement-discretion-and-remove-all-unauthorized-e-cigarettes-from-the-market). “Companies like JUUL understand that they've promoted their products to children. For years none of these products were legally authorized. Who is the cop on the beat?”

“This means that some of the most popular youth brandsincluding flavored products that have driven the youth e-cigarette epidemiccould remain on the market for yet another year without FDA authorization,” the healthcare organizations said (https://www.tobaccofreekids.org/press-releases/2022_05_19_fda-court-e-cig-review) in a collective statement. “These delays fly in the face of FDA’s own public statements to prioritize review of applications of products with the largest market share, and they undermine the court order’s intent to prevent e-cigarette productsespecially those appealing to kidsfrom remaining on the market without FDA review.”

FDA issued (https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products) marketing denial orders to JUUL Labs Inc. in June 2022, halting the distribution and sales of all its products, but other e-cigarette companies have products on the market. FDA was originally given a deadline (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-court-grants-fdas-request-extension-premarket-review-submission-deadline) of September 2021 to finish reviewing e-cigarette marketing applications.

FDA predicted (https://www.tobaccofreekids.org/assets/content/what_we_do/federal_issues/fda/2022_05_13_fdastatusreport.pdf) that it will review 56% of the applications reviewed by December 2022. The agency released a second status report (https://www.tobaccolawblog.com/wp-content/uploads/sites/454/2022/07/2022-07-28-AAP-v-FDA-D-Md-FDA-Status-Report.pdf) on its review process in July 2022 with no changes to those predictions. FDA will issue (https://www.tobaccolawblog.com/wp-content/uploads/sites/454/2022/07/2022-07-28-AAP-v-FDA-D-Md-FDA-Status-Report.pdf) a third report in October 2022.

ONS adds the oncology nurse’s expertise in educating patients and decision-makers (https://www.ons.org/make-difference/ons-center-advocacy-and-health-policy/position-statements/e-cigarettes-and-vaping) on the impact of tobacco, especially for minors, to the antismoking community. Flavored tobacco, electronic cigarettes, and vaping mechanisms have fueled the ongoing vaping epidemic (https://www.ons.org/make-difference/ons-center-advocacy-and-health-policy/position-statements/e-cigarettes-and-vaping) that nurses and other healthcare providers must address to improve public health.


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