The House Oversight Committee urged the Food and Drug Administration (FDA) in a letter on Wednesday to "clear the market" of e-cigarettes despite the Premarket Tobacco Application (PMTA) deadline. The National Institute on Drug Abuse (NIDA) warned Americans that “because it attacks the lungs, the coronavirus that causes COVID-19 could be an especially serious threat to those who smoke tobacco … or who vape,” and smokers and vapers “could find themselves at increased risk of COVID-19 and its more serious complications.” (Fox News)
What’s a PMTA?
Back in May 2016, the FDA announced a “deeming” rule stating that the PMTA guidelines would cover both the traditional market and the vape industry. This means that any vape product manufactured after August 8th, 2016 would need to file a PMTA so that the FDA can make sure the ingredients and everything used are safe. The PMTA would then be approved or declined for the sale of these products. When the deeming rule was implemented, a deadline for August 8th, 2018 was set for vape manufacturers to submit their PMTA’s. The next year (July 2017) the new FDA Commissioner, Scott Gottlieb, announced the deadline would be postponed until August 8th, 2022. The deadline was later set to May 12th, 2020 by District Judge Paul Grimm of the U.S. District Court for the District of Maryland.
PMTA Delay Request
With only a few weeks left until the May 12th PMTA deadline, the FDA asked Judge Paul Grimm for a 120-day delay for vape manufacturers to submit applications and be able to keep their products on the market. Illinois's 8th congressional district Representative, Raja Krishnamoorthi, sent a letter to FDA Commissioner Stephen Hahn on April 1st requesting for the FDA to “clear the market” of all vaping products, stating in the letter, “The Subcommittee is not necessarily opposing FDA’s request for a delay or suggesting that FDA divert staff away from responding to the coronavirus crisis,” “Instead, the Subcommittee is requesting that FDA clear the market of e-cigarettes during this delay. Allowing e-cigarettes to remain on the market during this period would harm children and adults throughout the country and exacerbate the coronavirus crisis in critical ways,”
Mitch Zeller, the director of the FDA's Center for Tobacco Products, said in a letter to Grimm, filed on March 30th. "The 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 also mentioned that many companies have closed labs, factories, and offices overseas, making it difficult for companies to complete their PMTA’s on time.
Do you think the PMTA deadline should be extended? Leave your thoughts in the comments below!
Rambaran, V. (2020). Oversight Committee urges FDA to ban e-cigarettes, vaping over coronavirus risks. Retrieved 8 April 2020, from https://www.foxnews.com/politics/oversight-committee-fda-ban-e-cigarettes-vaping-coronavirus-risks
FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus (1). (2020). Retrieved 8 April 2020, from https://news.bloomberglaw.com/health-law-and-business/fda-asks-judge-to-delay-e-cigarette-deadline-citing-coronavirus
McDonald, J. (2020). Rep. Krishnamoorthi to FDA: Ban All Vapes During PMTA Delay - Vaping360. Retrieved 8 April 2020, from https://vaping360.com/vape-news/89499/rep-krishnamoorthi-to-fda-ban-all-vapes-during-pmta-delay/
FDA Asks Court to Delay PMTA Deadline for Vapor Products. (2020). Retrieved 8 April 2020, from https://csnews.com/fda-asks-court-delay-pmta-deadline-vapor-products