FDA WARNING_LETTER - Hastings Vapors LLC d/b/a Hastings Vapors - February 16, 2023

On February 16, 2023, the FDA issued a Warning Letter to Hastings Vapors LLC d/b/a Hastings Vapors, following a review of submissions and inspection records. The FDA determined that Hastings Vapors manufactures and distributes e-liquid products, specifically "Watermelon e-liquid products," for commercial distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Watermelon e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter states that the doing of any act resulting in adulterated or misbranded tobacco products held for sale after interstate shipment is a prohibited act under section 301(k), and failure to provide a required report under section 905(j) is a prohibited