FDA WARNING_LETTER - Boardwalk Elixir, LLC - March 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Alex Rangel of 609 Bradford Ave. Suite 103, Kemah, TX 77565, following a review of the website https://boardwalkelixir.com. The review determined that e-liquid products, specifically "Boardwalk Elixir Melon Dew" and "Boardwalk Elixir Café Con Leche," are manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they are derived from tobacco, intended for human consumption, and were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products are being marketed without the required premarket authorization order from the FDA, as mandated by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required notice or information under section 905(j).

The letter emphasizes the firm'