TJD Holdings, Inc. d/b/a Venturi – FDA Warning Letter, Mar 31, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Timothy J. Dutmers regarding TarGard Cigarette Filter products, including TarGard Permanent, Original Disposable, and Mini Disposable Cigarette Filters, sold on targard.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are adulterated under section 902(8) because they are modified risk tobacco products sold without an FDA order.

The website and/or product labels make numerous claims implying reduced risk, harm, or exposure to substances, such as "Cut the Tar ... Keep the Taste," "TarGard Cigarette Filters trap sticky tars BEFORE they enter your body," "removing more tar from your smoke," "save your lungs from [sic]," "helps prevent gum disease," "REGAIN LOST LUNG CAPACITY," "Aide Smoker's Cough," "RELIEVE SORE & SWELLEN GUMS," and "healthier alternative." These claims classify the products as modified risk tobacco products under section 911(b)(2)(A)(i) of the FD&C Act.

The letter states that introducing or delivering modified risk tobacco products into interstate commerce without an FDA order under section 911(g) is a violation, rendering the products adulterated. The company must immediately correct these violations and ensure compliance with the FD&C Act and FDA regulations for all tobacco products, labeling, and advertising across