Adirondack Juice LLC d/b/a Adirondack Vapor & Co. Warning Letter Details

Summary

Adirondack Vapor & Co. was warned for manufacturing and selling e-liquid tobacco products without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that e-liquids offered on the company's website met the definition of tobacco products subject to FDA jurisdiction under the FD&C Act as "new tobacco products" requiring marketing authorization prior to sale. The company had failed to obtain the necessary premarket authorization orders required for e-liquids to be legally marketed in the United States.