FDA WARNING_LETTER - McCraney Enterprises Corporation d/b/a Vapors Heaven - June 23, 2022

The FDA issued a Warning Letter to McCraney Enterprises Corp. d/b/a Vapors Heaven on June 23, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Vapors Heaven Sweet Milk 3ml nic 120ml e-liquid is 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 product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided. The failure to provide a required report under section 905(j) is also a prohibited act.

McCraney Enterprises Corp. is a registered manufacturer with over 100 products listed. Their Premarket Tobacco Product Application (PMTA) STN PM0003851, covering 122 products, received a Refuse To Accept determination on February 25, 2022. All new tobacco products on the market without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction.

The company must respond within 15 working days, detailing actions to address violations, including discontinuing sales/distribution of viol