FDA WARNING_LETTER - E-Cig Barn, LLC - January 15, 2021

On January 15, 2021, the FDA Center for Tobacco Products issued a Warning Letter to Wayne Weigold regarding e-liquid products sold on ecigbarn.com. The FDA determined that e-liquid products, specifically "Barn Brew Hannibal Nectar" and "Barn Brew Walken’ Dead," are manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The FDA found that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these e-liquid products lack the required premarket 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 letter emphasizes the firm's responsibility, as a registered manufacturer with over 100 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions