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VPR Collection was warned for selling electronic nicotine delivery system (ENDS) products without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's products are tobacco products subject to FDA jurisdiction under section 901(b) of the FD&C Act because they contain nicotine from any source and are intended for human consumption. As "new tobacco products" not commercially marketed in the United States as of February 15, 2007, these ENDS products were required to obtain a marketing authorization order under section 910 of the FD&C Act before being legally distributed in the U.S., which VPR Collection failed to do.