Eon Pods, LLC d/b/a Eon Smoke Pods – FDA Warning Letter, Aug 25, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Eon Pods, LLC, following a review of their website, https://www.eonpods.com, which revealed the sale and distribution of Electronic Nicotine Delivery System (ENDS) products in the United States. These products, including "Eon PODS – Silky Strawberry," "Eon PODS – Blueberry," and "Eon PODS – Watermelon," are classified as tobacco products under the FD&C Act.

The core violation is 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 order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided.

The FDA requires the company to promptly correct these violations, including discontinuing the violative labeling, advertising, sale, and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in regulatory action, including detention and refusal of admission