FDA WARNING_LETTER - MyVapor-Lounge LLC d/b/a Winter Garden Ecigs - March 02, 2022

The FDA issued a Warning Letter to MyVapor-Lounge LLC d/b/a Winter Garden ECigs on March 2, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the marketing of "Top Shelf Eliquid Tropical Fusion 1.5mg" without the required premarket authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). The failure to provide such a report is a prohibited act under section 301(p), and any act resulting in adulteration or misbranding while held for sale after interstate shipment is prohibited under section 301(k).

The FDA noted that the firm is a registered manufacturer with over 1,000 listed products. The letter emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction.