Ram Goods LLC – FDA Warning Letter, Apr 18, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Ram Goods LLC on April 18, 2024, based on a review of inspection records. The company sells and/or distributes Electronic Nicotine Delivery System (ENDS) products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, ten varieties of "Wave 10k Puff – Devices" (Banana Straw, Kiwi Watermelon, Lush Ice, Mintopia, Pink Burst, Raspberry Watermelon, Rainbow Snow Cone, Paradise Fruit, Spearmint, and Peach Ice) are cited. These products are considered new because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. Ram Goods LLC is required to submit a written response within 15 working days detailing actions to address these violations, including discontinuing sales and distribution of the non-compliant products, and a plan for future compliance. Failure to