FDA WARNING_LETTER - K&D Vapors Inc - February 23, 2023

The FDA issued a Warning Letter to K&D Vapors Inc. on February 23, 2023, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that K&D Vapors Inc. manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

Specifically, the product "K&D Vapors Annie Oakly 3mg Nicotine 60ml e-liquid" is identified as a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

K&D Vapors Inc. had submitted a Premarket Tobacco Product Application (PMTA), STN PM0005098, which was refused to file on August 26, 2022, covering 1,459 products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions