Lufkin Vapor Supply/Vapin Texas LLC d/b/a Toot Juice & Vapor Supply – FDA Warning Letter, Aug 18, 2020

On July 31, 2020, the FDA issued a Warning Letter to Roy Hufstetler regarding electronic nicotine delivery system (ENDS) products sold on texastootjuice.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation is the sale of "new tobacco products" without required premarket authorization, as mandated by section 910(a) of the FD&C Act. The specific products cited include various flavors of VQ Pod Juice (Strawberry Milk, Mango Bliss, Super Berry, Watermelon Ice, Peach, Raspberry Sweet Tea, Wild Cherry, Grape Soda, Sampler Pack, and Variety Pack). These products are considered "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these ENDS 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 premarket notification under section 905(j).

The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory action, including detention and