FDA WARNING_LETTER - Leaf Only LLC

The FDA Center for Tobacco Products issued a Warning Letter to Leafonly.com (Mr. Wallace and Mr. Stone) after reviewing their website, which offers cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products for sale in the U.S. The FDA determined that several cigarette tobacco and/or roll-your-own tobacco products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order. These products, including "456 Semi-Oriental," "Aged Burley," and "Brightleaf Combo," use descriptors like "light" or "mild."

Additionally, several smokeless tobacco products, such as "Aged Burley" and "Dark Fire Cured," are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because their webpages lack required health warning statements. The letter emphasizes that the company must also comply with other regulations, such as the quarterly rotation of warning labels for smokeless tobacco.

Leafonly.com is required to immediately correct all violations and submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.