D&A Distribution, LLC d/b/a Strictly E-cig Warning Letter Details

Summary

D&A Distribution, LLC d/b/a Strictly E-cig was warned for importing and distributing electronic nicotine delivery systems (ENDS) products without required FDA premarket authorization. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act, which requires new tobacco products—including ENDS products containing nicotine from any source—to obtain premarket authorization before legal marketing in the United States. The FDA determined the company was offering these tobacco products for sale or distribution to customers in the U.S. without the necessary regulatory clearance.