FDA WARNING_LETTER - The Vape Store #1 - July 14, 2022

The FDA issued a Warning Letter to The Vape Store Inc. on July 14, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "THE VAPE STORE HAZELMILK 4.5mg 50ml" e-liquid product without the required premarket authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The company is a registered manufacturer with over 12,000 listed products. Their Premarket Tobacco Product Applications (PMTAs) for STNs PM0003610 and PM0004665, covering 122 and 104 products respectively, received Refuse To Accept determinations on April 21, 2021, and December 14, 2021. These products are also considered adulterated