FDA WARNING_LETTER - Ejuicepack, LLC - April 27, 2020

The FDA issued a Warning Letter to Yash Pandit regarding e-liquid products offered for sale on ejuicepack.com, which are deemed tobacco products subject to FDA regulation. A review determined that the company is selling "new tobacco products" without the required premarket authorization, as these products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these e-liquids are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices or information under section 905(j). The failure to provide such reports is also a prohibited act under section 301(p). The FDA expressed significant concern that some products, specifically Pink Sticks, Candy King Batch, and Candy King Sour Worms e-liquids, imitate food products appealing to children, exacerbating public health risks associated with youth ENDS use. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance, to avoid potential enforcement actions such as civil money penalties, seizure, or injunction.