As per the Family Smoking Prevention & Tobacco Control Act, back in 2016 the FDA had announced that all tobacco products would need to apply for and obtain a PreMarket Tobacco Application Authorization (PMTA) in order to stay on the US market.
Since then, the deadline for this application has been moved back and forth a number of times, until on April 3rd 2020, Judge Paul Grimm of the United States District Court for the District of Maryland, moved the deadline to September 9th, 2020.
According to the Tobacco Act, all tobacco products need to be authorized for every aspect, including adjustments in packaging, manufacturing processes, and product design. This makes obtaining the authorization very costly and time-consuming leading many smaller vape businesses into bankruptcy or insurmountable debts.
Warning letters
Meanwhile, the FDA has issued its first set of warning letters to firms who have not yet submitted their PMTAs and are therefore selling unauthorized products.
In a release on its website, the agency explained that for companies that submitted applications by the set deadline, the FDA generally continues to defer enforcement for up to one year pending review, unless there is any required action.
PMTA data made public
Moreover last September, the agency had also announced that the normally secretive process will be made public, and the agency will be publishing a list of firms which had not yet filed their applications. The announcement was made by Mitch Zeller, director of the FDA’s Center for Tobacco Products, via a blog post, by which time the agency had already received applications for approximately 2,000 e-cigarettes and other newly regulated tobacco products.
Zeller had pointed out that there were over 400 million that required a PMTA in order to remain on the market and the warning letters were sent to the following firms: Little House Vapes LLC; Castle Rock Vapor LLC; Dropsmoke Inc.; Perfection Vapes Inc.; CLS Trading LLC d/b/a Vape Dudes HQ; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors LLC; Dr. Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid; CMM Capital LLC d/b/a ETX Vape; and E-Cig Barn LLC.
“These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
“The FDA will continue to prioritize enforcement against companies that market electronic nicotine delivery systems (ENDS), including e-cigarettes, without the required authorization but haven’t submitted a premarket application to the agency, including those products with a likelihood of youth use or initiation.
