China First Union d/b/a Beco Vape – FDA Warning Letter, Jan 23, 2024

On December 8, 2023, the FDA issued a Warning Letter to the operator of becovape.com after determining that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the U.S. These products are considered tobacco products under the FD&C Act, as amended on March 15, 2022, to include products with nicotine from any source.

The FDA found that specific ENDS products, including "Beco Pro Disposable Vape 6000 Puff" in Blue Razz, Mango Ice, and Rainbow flavors, are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt.

Consequently, these products are 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 under section 905(j). The FDA has not received marketing authorization applications for these products.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such