FDA WARNING_LETTER - Mr. Smokey Tobacco Corp. d/b/a Hqdpods.com - May 31, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to the recipient at 70 West 49th St, Hialeah, FL 33012, following a review of the website https://hqdpods.com. The FDA determined that Electronic Nicotine Delivery System (ENDS) products, specifically "Puff Plus - Mixed Berries" and "Puff Plus - Lychee Ice," are offered for sale or distribution to U.S. customers.

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source. The FDA found these ENDS products to be "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket 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 for not providing required information under section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales/distribution and a plan for future