FDA WARNING_LETTER - JTBC Holdings LLC d/b/a Disposable305 - May 31, 2023

On May 31, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Joseph J Benhamu Cohen and Tamar R. Benhamu Cohen, following a review of their website, https://thedisposablevapes.com. The FDA determined that the website offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products, specifically "Puff Plus – Orange Soda" and "Puff Plus – Aloe Grape."

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source. The FDA found that these ENDS products are "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. The letter states that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement action. The recipients are required to submit a written response within 15 working days, detailing