Miami, FLA, Jan. 16, 2021 (GLOBE NEWSWIRE) -- The FDA issues first set of warning letters to 10 firms manufacturing and selling unauthorized electronic nicotine delivery system (ENDS) products.
FDA warning letters have been sent to firms who continue to manufacture and illegally sell e-liquid products lacking premarket authorization. These firms have neglected to submit Premarket Tobacco Applications by the required deadline. Premarket Tobacco Applications (PMTA) were required to be submitted for all e-liquid products and vaping devices on the market as of August 8th, 2016, by the court-ordered September 9th, 2020 deadline. Any such product lacking a PMTA is considered to be illegal in the US.
The 10 firms receiving warning letters are as follows:
Little House Vapes LLC
Castle Rock Vapor LLC
Perfection Vapes Inc.
CLS Trading LLC dba Vape Dudes HQ
Session Supply Co.
Coastal E-Liquid Laboratory
GC Vapors LLC
Dr. Crimmy LLC dba Dr. Crimmy’s V-Liquid
CMM Capital LLC dba ETX Vape & E-Cig Barn LLC
According to the FDA, once letters are received, these firms will have 15 days to respond with specific dates on which unauthorized products have been removed from the US market, as well as plans to maintain compliance.
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PMTA Verified was born in 2016, to a nonprofit organization founded by a group of concerned Vapers and Industry leaders. PMTA Verified is led by an Emergency Room Physician and a passionate group of professionals that have all witnessed the impacts of limited solutions and misinformation within the communities and patients they serve.
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