FDA Issues Warning to E-Cigarette Manufacturers
February 15, 2021
In a press release on Monday, the Food and Drug Administration (FDA) announced that it has issued warning letters to 10 different companies which both manufacture and sell electronic nicotine delivery system (ENDS) products, like e-cigarettes. The letters said that the firms had not received pre-market authorization to sell e-liquid products and so they are currently being sold and distributed illegally.
The FDA said these letters are the first set to be sent to companies who missed the September 9, 2020 deadline for submitting a premarket tobacco product application (PMTA) but are continuing sales regardless. A court previously ruled that manufacturers of new tobacco and e-liquid products developed since August 2016 needed to submit a PMTA before the 2020 deadline.
FDA Tells Firms That Didn t Submit PMTA Applications to Stop Selling Product
SILVER SPRING, Md. The Food and Drug Administration (FDA) sent warning letters to 10 companies for selling electronic nicotine delivery systems (ENDS) specifically e-liquids even though they did not file premarket tobacco applications (PMTAs) by the Sept. 9, 2020 deadline.
The letters are the first the agency issued since to companies that continue to sell or distribute unauthorized ENDS passed the deadline.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016, including e-liquids, were required to be submitted to the FDA by Sept. 9, the agency explained.
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 8
th, 2016, by the court-ordered September 9
th, 2020 deadline. Any such product lacking a PMTA is considered to be illegal in the US.