FDA WARNING_LETTER - Rip It Vapors, LLC - August 18, 2022
Discuss this record with AI
The FDA issued a Warning Letter to Rip It Vapors, LLC on August 18, 2022, following a review of submissions and inspection records. The FDA determined that Rip It Vapors manufactures and distributes e-liquid products, including those containing nicotine from any source, which are classified as tobacco products under the FD&C Act.
The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "RIP IT VAPORS Just Rip It Blue Doom 3mg 60 ml Tobacco Free Nicotine," "TOP GRADE VAPORS Black Label King Booberry 3mg 60 ml Tobacco Free Nicotine," and "TOP GRADE VAPORS Black Label Tobacco Gold 3mg 60 ml Tobacco Free Nicotine" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders or exemptions.
These products are cited as adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the lack of required marketing authorization and failure to provide necessary reports under section 905(j). Prohibited acts under sections 301(k) and 301(p) of the FD&C Act are also noted.
Rip It Vapors is required
ID · 4519bd87-682f-4ab9-ac89-ef420c45e951
Full citation text and observation details available on the Dashboard.