FDA WARNING_LETTER - Tally Ho Vapor Tonic LLC - February 26, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Tally Ho Vapor Tonic LLC after reviewing their website, https://tallyhovaportonic.com. The FDA determined that e-liquid products listed on the site are manufactured and offered for sale or distribution in the U.S. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, Tally Ho Vapor Frosted, Tally Ho Vapor Wayfarer, and Tally Ho Vapor Atlas e-liquid products were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 30 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working