FDA WARNING_LETTER - Weidenhamer and Morin Enterprises LLC d/b/a Liquivape - September 14, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Michael Weidenhamer and Timothy Morin of Liquivape, based on a review of their website, liquivapeus.com. The FDA determined that e-liquid products, specifically "Liquivape Gummi Bearz" and "Liquivape Swedish Phish," are manufactured and offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes the firm's responsibility as a registered manufacturer with over 1,000 listed products to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm