FDA WARNING_LETTER - Alternative Pods - September 01, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Alternative Pods after reviewing their website, alternativepods.com, which advertises and sells Electronic Nicotine Delivery System (ENDS) products in the U.S. These products, including MR FOG Pods – Banana Ice Cream, Ziip Pods – Iced Apple, and Zalt Pods – Blue Raspberry, are deemed tobacco products under the FD&C Act.

The FDA determined that these ENDS products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided.

Alternative Pods is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.