FDA WARNING_LETTER - Hookies and Bookies - February 03, 2022

On February 3, 2022, the FDA issued a Warning Letter to Hookies and Bookies for manufacturing and distributing e-liquid products, specifically "Red Apple Nic 0.3salt e-liquid," without required premarket authorization. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The "Red Apple Nic 0.3salt e-liquid" product is classified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. The company failed to obtain a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act or demonstrate an exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The FDA cited prohibited acts under sections 301(k) and 301(p) of the FD&C Act for holding for sale an adulterated or misbranded product and failing to provide a required report, respectively. Hookies and Bookies is a registered manufacturer with over 1,300 listed products. The FDA emphasized that