FDA WARNING_LETTER - TheSY, LLC d/b/a Element Vape - May 31, 2023

On May 31, 2023, the FDA issued a Warning Letter to Kenny Sy, Christopher Sy, and Vinh Sy of Element Vape (https://www.elementvape.com) for offering for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products without required marketing authorization. The FDA determined that products like Hyde Rebel, Hyde Retro, and Hyde Edge are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or substantial equivalence reports. The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

Element Vape is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales and a plan for maintaining compliance. Failure to comply may lead to further regulatory or legal action.