FDA has issued warning letters to ten vape businesses that are still manufacturing and selling vaping products without initially obtaining a PMTA.
As per the 2009 Family Smoking Prevention & Tobacco Control Act, the FDA had declared that all tobacco products should need to apply and get a PMTA in order to stay on the US market.
Following this, the deadline for the PMTA application has been moved back and forth numerous times. That’s until on the 3rd of April last year, Judge Paul Grim from the US District Court for the District of Maryland, finalized the deadline to the 9th of September, 2020.
According to the law, all tobacco products should be authorized for every aspect, including the manufacturing process, adjustments in packaging as well as product designs. This makes it difficult, time-consuming, and costly to obtain authorization. Thus, smaller vape businesses ended up with insurmountable debts or, worse, declaring bankruptcy.
What is PMTA?
Short for Pre-Market Tobacco Application, PMTA is an application that must be submitted by tobacco-product manufacturers and sellers for review and approval of the FDA before a new tobacco product can be marketed in the US, legally.
Issuing of Warning Letters
The FDA has delivered the first set of warning notice to businesses still operating that have not yet applied for a PMTAs and are, hence, selling unauthorized products.
The warning letters were sent to the following businesses:
- E-Cig Barn LLC
- Little House Vapes LLC
- CMM Capital LLC d/b/a ETX Vape
- Castle Rock Vapor LLC
- CLS Trading LLC d/b/a Vape Dudes HQ
- Perfection Vapes Inc
- GC Vapors LLC/Coastal E-Liquid Laboratory
- Session Supply Co.
- Dr. Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid
- Dropsmoke Inc.
These warning letters are the outcome of continued internet monitoring and surveillance for violations of tobacco laws and regulations. The FDA also stated that they are keeping a close watch on the tobacco marketplace and will hold tobacco product retailers and manufacturers accountable for breaking the law.
Furthermore, the FDA promises to continue to deal and prioritize enforcement against businesses and companies that market and sell ENDS (electronic nicotine delivery systems) products including e-cigarettes and vapes, without the required authorizations and PMTAs.
In a press release on its website, the FDA explained that for companies that submitted applications by the established deadline like GeekVape and GeekVape Aegis Legend, they will continue to defer enforcement for up to 1-year pending review, unless there’s any required action.
Publicizing PMTA Data
Last September, the FDA also announced that the normally secretive process will be publicized. They will be publishing a list of businesses that had not yet filed for their applications.
This announcement was made by the director of the FDA’s Center for Tobacco Products, Mitch Zeller, via a blog post. By the time the announcement was posted, the FDA already received applications for about 2,000 e-cigarettes, vapes, and other newly regulated tobacco products.
Still, Zeller pointed out that there were at least 400 million businesses that required a PMTA to stay on the market.
