FDA WARNING_LETTER - Maduro Distributors d/b/a The Loon - August 31, 2021

The FDA issued a Warning Letter to Mohammed Wazwaz, operating via the website https://theloonmn.com, for manufacturing and selling unauthorized electronic nicotine delivery system (ENDS) products. The FDA's review determined that products like "Loon 300 – Pink Lemonade" and "Loon Bullet Bubble Gum" are "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007.

These products are deemed adulterated under section 902(6)(A) of the FD&C Act because they lack the required premarket authorization order under section 910(c)(1)(A)(i). They are also misbranded under section 903(a)(6) for failing to provide required notice or information under section 905(j).

Although the firm is a registered manufacturer with over 200 products listed and submitted a Premarket Tobacco Product Application (PMTA) for 18 products, it continues to market unauthorized new tobacco products not covered by the PMTA. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.