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”) earlier this week.
While COVID-19 has had a profound effect on daily consumer life, the agency request is 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.
Proposed 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 would update electronic nicotine delivery system (“ENDS”) enforcement guidelines accordingly.
“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 detailed 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
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
In May of 2016, FDA published regulations that gave vape and e-cigarette companies two years from the date of effect - anticipated to be August 8, 2016. Businesses were to prepare and submit documentation to FDA disclosing the ingredients used in e-cigarette liquids, thus establishing the safety of such liquids in order to have their products remain on the market.
Four years and several lawsuits later, regulators and consumers still don’t even know what’s in these liquids much less how safe they are, despite being on the market since roughly 2008.
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
It is clear that the COVID pandemic and the economic disaster was unprecedented, however, it is dismaying to watch the vaping industry operate without regulation for over a decade as lawsuits and lobbying advocate further delay to FDA oversight of ENDS products. It is the firm's hope that once the COVID-19 threat is contained, FDA can swiftly and resolutely bring much-needed visibility and confirmation of safety to the vape industry.
- 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).”
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Originally published April 2, 2020, at https://therodmanlawgroup.com.