FDA WARNING_LETTER - East Coast Vapors, LLC d/b/a VapeScorpion.com - August 18, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Michael Piker concerning e-liquid products advertised on vapescorpion.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and fall under FDA jurisdiction. The primary violation identified was that the website advertising for an e-liquid product, specifically citing "Heisenberg (THEBERG)," failed to include the required nicotine warning statement. This violates 21 CFR 1143.3(b), which mandates that advertising for covered tobacco products must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." As a result, the e-liquid product is deemed misbranded under section 903(a)(7)(B) of the FD&C Act. The letter stresses the firm's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations. A written response is required within 15 working days, detailing corrective actions, including the discontinuation of violative advertising and a plan for sustained compliance. Failure to address these violations may lead to further regulatory action, including the detention and refusal of admission for misbranded tobacco products offered for import.