FDA WARNING_LETTER - Bluum Lab LLC - April 12, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Yehuda Gabay and Elad Barda of Bluumlab.com on April 8, 2022, following a review of their website. The FDA determined that Bluumlab.com manufactures and offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, which are regulated as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the products "Nano Pod CBD Vape With Salt Nicotine – Mango," "Nano Pod CBD Vape With Salt Nicotine – Berry," "CBD Cartridges with Salt Nicotine 2pk – Mint," and "CBD Cartridges with Salt Nicotine 2pk – Tobacco" were found to be new tobacco products not commercially marketed in the U.S. as of 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.

Bluumlab.com is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the violative marketing, sale, and distribution, and outlining a plan for future compliance. Failure to comply may