FDA Warning Letter to E-Cigarette Direct LLC citing violations of the FDCA
WARNING LETTER
September 8, 2010
Ms. Sabina King
Registered Agent
E-CigaretteDirect, LLC
18695 Pony Express Drive
Parker, Colorado 80134
Dear Ms. King:
This letter concerns various brands of electronic cigarettes and cigars (e.g., “Gamucci,”“Smoking Everywhere,” and “Veppo”), and the components thereof (e.g., batteries and cartridges), that are marketed by your firm.
Based on our review of the products’ labeling and promotional materials, including your Internet website (www.e-cigarettedirect.com), each of these products, often called “e-cigarettes” and “ecigars,” is constructed with a lithium ion battery, a microprocessor, a heating element, and a replaceable cartridge that contains certain chemicals, including nicotine (in varying specified levels). These products do not contain tobacco leaf or stem.
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