FDA WARNING_LETTER - Mom and Pop Vapor Shop - August 23, 2022

The FDA issued a Warning Letter to Mom and Pop Vapor Shop after reviewing their website, momandpopvaporshop.com, and identifying e-liquid products offered for sale. These products, including "Mom and Pop Vapor Shop Fruity Lips" and "Mom and Pop Vapor Shop Cream Pie," are classified as "tobacco products" under section 201(rr) of the FD&C Act, particularly following the March 2022 amendment extending FDA's jurisdiction to products containing nicotine from any source. The primary violation is the manufacturing and offering for sale of these "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required notice or information under section 905(j). The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing the violative sale and distribution, and outlining a plan for future compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, product seizure, or injunction.