FDA WARNING_LETTER - Nicotine Nirvana - May 18, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Cliff Loeb of Nicotine Nirvana on May 7, 2021, following a review of their website, https://www.nicotinenirvana.com. The FDA determined that Nicotine Nirvana manufactures and sells e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products "Nicotine Nirvana Cinnamon Roll," "Nicotine Nirvana Gummi Bears," "Nicotine Nirvana Juicy Watermelon," and "Nicotine Nirvana Milk Chocolate" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Nicotine Nirvana, a registered manufacturer with over 50 products listed with the FDA, is responsible for ensuring compliance across all its tobacco products, labeling, and advertising. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The letter requires a written response within 15 working days detailing corrective actions, including discontinuation