FDA WARNING_LETTER - Tobacco Outlet Express LLC

The FDA issued a Warning Letter to Smokin-G.com (Tobacco Outlet Express, LLC) after reviewing their website, determining their products are manufactured and promoted for sale in the U.S. The FDA classified their "pipe tobacco" as "cigarette tobacco" under the FD&C Act, citing website content that suggests use in cigarettes, such as a "Find My Blend" section pairing Smokin'G blends with cigarette tubes to mimic cigarette brands.

The company was cited for promoting "Smokin'G MINT Blend" and "Smokin'G CLT Blend" as "light" by describing them as comparable to "Newport Light" and "Newport Light ALT" cigarettes. This constitutes promoting modified risk tobacco products without an FDA order, violating section 911(a) of the FD&C Act, rendering them adulterated under section 902(8).

Additionally, the "Smokin'G MINT Blend" was cited for being a flavored cigarette tobacco, violating section 907(a)(1)(A) of the FD&C Act, making it adulterated under section 902(5). If it lacks a characterizing flavor, it is misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling.

The FDA requires immediate corrective actions, including discontinuing violative promotion, advertising, sale, and distribution, and