FDA WARNING_LETTER - Trees Vape Supply LLC d/b/a Tea Time Eliquid Co. - September 20, 2022

The FDA issued a Warning Letter to Kevin Bowers, owner of teatimeliquid.com, on September 9, 2022, following a review of their website. The FDA determined that e-liquid products, including Peach Mango Tea, Raspberry Limeaid Tea, and Mixed Berry Tea, are manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Since these e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution, and a plan for maintaining compliance.