Today, FDA issued warning letters to 9 firms who manufacture and sell unauthorized electronic nicotine delivery systems (ENDS),

FDA Warns Additional Firms for Making and Selling Unauthorized E-Liquids Today, FDA issued warning letters to 9 firms who manufacture and sell unauthorized electronic nicotine delivery systems (ENDS), advising them that selling products which lack premarket authorization is illegal, and therefore they cannot be sold or distributed in the U.S. The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline. The firms receiving warning letters are The Mad Alchemist LLC; Austin Vapor; BloVape; Bombay Vapor LLC; Chief Vapor; American Legends E-Liquid, LLLP; Average Joes Juice LLC; Cloud Chasers Apothecary LLC; and Carolina Vapor Mill, LLC d/b/a Carolina Vapor Mill. While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of over 100,000 products with the FDA. The warning letters issued today follow the first set of such warning letters announced earlier this month. 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 FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application. In line with the agency's stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA