FDA ISSUES WARNING LETTERS TO 10 FIRMS MANUFACTURING AND SELLING UNAUTHORIZED E-LIQUID PRODUCTS
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
- Dropsmoke Inc.
- 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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