FDA WARNING_LETTER - ivygang.com - July 29, 2025

The FDA issued a warning letter to Ivy Smoker’s Boutique, operated by Allabani Holdings, Inc., concerning violations related to electronic nicotine delivery system (ENDS) products sold on their website, ivygang.com. The inspection revealed that products such as Mr. Fog Switch – Banana Raspberry Ice and Mr. Fog Switch – Bubble Gang Watermelon Ice are being marketed without the necessary FDA premarket authorization. These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially available in the U.S. before February 15, 2007.

Under the FD&C Act, all new tobacco products must have a marketing authorization order unless they meet specific exemption criteria. The lack of such authorization renders these products adulterated and misbranded, making their sale unlawful. The FDA"s jurisdiction over these products was reinforced by the Consolidated Appropriations Act, 2022, which expanded the definition of tobacco products to include those containing nicotine from any source.

The FDA has requested Ivy Smoker’s Boutique to take immediate corrective actions to comply with the FD&C Act. The company must submit a written response within 15 working days detailing the steps taken to address the violations, including cessation of sales and distribution of the non-compliant products. Failure to comply may result in enforcement actions, including penalties, seizure, or injunction. The letter serves as a formal notification and an opportunity for the company to rectify the issues.