StrikesUSA – FDA Warning Letter, Aug 23, 2023

On August 23, 2023, the FDA issued a Warning Letter to Colin Leung & Mark Frykholm regarding electronic nicotine delivery system (ENDS) products sold on strikesusa.com. The FDA determined that products like "VPro Mini Cup 6800 Disposable Vape - Cotton Candy" and "EB Design Elf Bar BC5000 Disposable Vape – Malibu" are tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

These products are considered "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, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern about the VPro Mini Cup products, noting their labeling and design imitate beverage containers, potentially promoting youth use and concealing their nature as tobacco products. The letter emphasizes that sales of such unauthorized products are prohibited and contribute to public health concerns.

The firm must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply