DripTip Vapes LLC – FDA Warning Letter, Sep 8, 2020

On August 21, 2020, the FDA issued a Warning Letter to Av Gavriel regarding electronic nicotine delivery system (ENDS) products sold on driptipvapes.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 identified is the sale of "new tobacco products" without required premarket authorization. Products like Stig Pods Lush Ice Pack of 4, Strawberry Lemonade Juul Compatible Ziip Pods, Pina Colada Atom Pods (4-Pack), and Eonsmoke Lush Ice JUUL Compatible Pods were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

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 premarket notification under section 905(j).

The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and advertising, and a plan for sustained compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.