FDA WARNING_LETTER - The Nic Salt - October 06, 2020
The FDA Center for Tobacco Products issued a Warning Letter to the recipient at 1305 John Reed Ct, City of Industry, CA, on August 21, 2020. The letter states that a review of the website https://thenicsalt.com revealed the sale and distribution of Electronic Nicotine Delivery System (ENDS) products to U.S. customers.
These ENDS products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. Effective August 8, 2016, ENDS products require premarket authorization as "new tobacco products" if not commercially marketed in the U.S. as of February 15, 2007, or if modified thereafter.
The FDA identified specific ENDS products, including "Plus Pods Compatible Pods - Green Apple," "Eonsmoke Compatible Pods - Tropical Pineapple," and "Loon Compatible Pods - Blueberry Bliss," as new tobacco products lacking the required FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).
The letter
ID · b53ad433-8c92-42e7-a053-a429a659543c
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