FDA WARNING_LETTER - Drippers Vape Lounge - November 09, 2021

The FDA issued a Warning Letter to Drippers Vape Lounge on November 9, 2021, for manufacturing and distributing unapproved new tobacco products. The FDA determined that e-liquid products, including DRIPPERS 6 3MG, DRIPPERS ANC 3MG, and DRIPPERS BCKS 3MG, are tobacco products subject to FDA regulation. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. The firm's Premarket Tobacco Product Applications (PMTA), STN PM0003572, covering 2,000 products, received a Marketing Denial Order on September 14, 2021.

The FDA considers products without pending applications or those with Marketing Denial Orders as high enforcement priorities. The letter requires a written response within 15 working days detailing actions to address violations, including discontinuing violative sales and a plan for compliance