COVID-19 ISO Insights

FDA Extends E-cigarette Premarket Review Deadline Due to COVID-19 Crisis

May 11, 2020

By: Christopher Sirota, CPCU

Back in 2019, The Hill reported that a federal judge had “ordered the Food and Drug Administration (FDA) to speed up its reviews of thousands of electronic cigarettes currently on the market.”

According to the article, the judge’s actions reflected his support of recent lawsuits filed by various public health groups, including the American Academy of Pediatrics, and the Campaign for Tobacco-Free Kids. These groups had sued the FDA, alleging, in part, that the delay of the premarket review was increasing the frequency of e-cigarette use by minors as the not-yet-approved products remained in the marketplace. Per the article, the aforementioned judge considered "the FDA's decision to delay reviewing electronic cigarette products for several years amounted to a serious dereliction of duty," and had ordered the FDA to submit a plan to review these products.

Per The Hill, at that time, the FDA had delayed enforcement of regulations until 2022. Subsequent to the judge's ruling, the FDA shortened the delayed enforcement time by newly requiring "manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020." (For details of the FDA premarket review process for tobacco products, see their guidance here).

Now, according to an FDA statement released on April 23, 2020, the FDA has moved the application filing date back to September 9, 2020 because of the COVID-19 crisis.

According to the statement:

The agency has received numerous inquiries from the tobacco industry expressing concern they will be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad. […] Another consideration was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on COVID-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications.

Of note, the statement explains that the court's ruling still allowed the FDA to "to exercise enforcement discretion" for up to one year after the application date, for companies that submit timely applications. Thus, a product could potentially be on the market until September 9, 2021 without the FDA taking action.