FDA WARNING_LETTER - Lineage Vapors LLC - January 24, 2023

On January 10, 2023, the FDA issued a Warning Letter to Kyle Ezzio regarding e-liquid products sold on https://lineagevapors.square.site. The FDA determined that products like Melon Strapple, Surreal Cereal, and Son of Peach are "new tobacco products" under the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack the required premarket authorization order under section 910(c)(1)(A)(i) or an exemption. The letter states that failure to comply with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143) may result in regulatory actions, including civil money penalties, seizure, and/or injunction.

The FDA 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. The response should be sent via email to [email protected] and to the specified mailing address.