This week, in a letter to federal Judge Paul Grimm, the U.S. Food and Drug Administration (“FDA”) requested a 120-day extension for e-cigarette product applications, citing the unforeseen impact of the novel coronavirus (“COVID-19”). This marks the most recent instance in a long line of delays, both legal and legislative, to FDA’s campaign to establish the safety of vapes and e-cigarettes.
Sent by FDA Director of the Center for Tobacco Products Mitch Zeller, the adjusted deadline for e-cigarette manufacturers to apply would be September 9, 2020. Should the extension be granted, the agency also intends to review and update electronic nicotine delivery system (“ENDS”) enforcement guidelines to best reflect the change.
“FDA remains acutely aware of the recent surge in youth use of e-cigarettes and the public health imperative to ensure that these and other deemed new tobacco products undergo premarket review,” Zeller wrote in the filing. “However, given the severe, unforeseen disruptions that are affecting this industry and the world, I believe it is appropriate for applicants to have an additional 120 days.”1
As a reminder, in May of 2016, FDA published regulations that were supposed to take effect on 8 August 2016. Vape and e-cigarette companies were to have two years from that date to prepare and submit documentation to FDA disclosing the ingredients used in e-cigarette liquids and establishing the safety of such liquids in order to have their products remain on the market. Four years and several lawsuits later, regulators (and thereby consumers) still don’t even know what’s in these liquids much less how safe they are. These products have been on the market since approximately 2008.
According to FDA spokeswoman Alison Hunt, many agency facilities have stalled or redirected operations due to the COVID-19 outbreak, with studies on human participants – like those needed for ENDS manufacturer applications – on suspension.2
The initial May 12, 2020, deadline was set by a 2019 lawsuit from the American Academy of Pediatrics, resulting in the U.S. District Court for the District of Maryland’s ruling of a 10-month deadline for ENDS applications to the FDA. Before said order, previous FDA Commissioner Scott Gottlieb had extended the Obama administration’s set application date into 2021 or beyond.
Zeller’s motion comes less than a week after Altria Group Inc. – a primary stakeholder in the country’s largest vaping company, Juul Labs Inc. – sent a letter to the FDA asking for an eight-week extension to submit product applications. One of over a dozen similar inquiries to FDA authorities, the Virginia-based tobacco giant requested the delay to correspond with the U.S. Centers for Disease Control and Prevention (“CDC”) social distancing recommendation.3
Ultimately, it is clear that no one expected the COVID pandemic and the economic disaster it has wrought, but it is incredibly frustrating to see an industry that has operated without regulation for more than a decade through a concerted effort of lawsuits and lobbying secure yet another delay to FDA oversight of their products. We hope that once the COVID threat is contained, FDA can finally (and quickly) bring the vape industry to heel. It would be great to at least know what is in these products, not to mention their safety profile.
- Maloney, Jennifer. “E-Cigarette Makers Could Get Extension on FDA Application.” The Wall Street Journal. Dow Jones & Company, March 30, 2020. https://www.wsj.com/articles/e-cigarette-makers-could-get-extension-on-fda-application-11585612823
- LaVito, Angelica. “FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus (1).” Bloomberg Law. The Bureau of National Affairs, Inc., March 31, 2020. https://news.bloomberglaw.com/pharma-and-life-sciences/fda-asks-judge-to-delay-e-cigarette-deadline-citing-coronavirus
- LaVito, Angelica. “FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus (1).”