Agera Tobacco, Inc. – FDA Warning Letter, Sep 14, 2023

The FDA issued a Warning Letter to Agera Tobacco, Inc. on September 14, 2023, following a review of inspection records. The FDA determined that Agera Tobacco, Inc. manufactures and distributes hookah tobacco products, specifically "Agera Hookah Tobacco Agera Blue 1kg" and "Agera Hookah Tobacco Mr Peach 1kg," for commercial distribution in the United States.

These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that Agera Tobacco, Inc. is marketing these new tobacco products without the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, and they are not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act 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 introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, and failure to provide a required report under section 905(j)