FDA WARNING_LETTER - ECig Warehouse, Inc. - September 01, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Peter Cocker regarding the sale of Electronic Nicotine Delivery System (ENDS) products on cloud99vapes.com. The FDA determined that products like EonSmoke – Grape JUUL Compatible Pods and Lava2 Pods – Apple with Mints are tobacco products under section 201(rr) of the FD&C Act and are 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. They lack the required premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of violative products, and a plan for maintaining compliance. Failure to comply may result in civil money penalties, seizure, injunction, and refusal of import. The FDA also sent copies to ECig Warehouse, Inc., GoDaddy.com, LLC, and Google, LLC.