FDA WARNING_LETTER - NYX E Cigarettes Incorporated - April 07, 2020

The FDA Center for Tobacco Products issued a Warning Letter to NYXECIGS.COM on March 27, 2020, after reviewing their website, https://www.nyxecigs.com. The review determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution to U.S. customers.

The identified violations concern the sale of "new tobacco products" without required premarket authorization. Specifically, the STLTH Pod Pack (3 Pack) - Strawberry and STLTH Pod Pack (3 Pack) - Blue Raspberry ENDS products were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007. These products lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information under section 905(j) was not provided.

The FDA requires NYXECIGS.COM to ensure all tobacco products and related labeling/advertising comply with the FD&C Act and FDA regulations. Failure to correct these violations may result in civil money penalties, seizure, and/or injunction. Adulterated and mis