Safa Goods, LLC Warning Letter Details

Summary

Safa Goods, LLC was cited for distributing Electronic Nicotine Delivery Systems (ENDS) products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA requirements applicable to tobacco products containing nicotine, which fall under FDA jurisdiction regardless of whether the nicotine is derived from tobacco or other sources following the 2022 legislative expansion of tobacco product definitions. The FDA determined that the company's ENDS products were being offered for sale or distribution in the United States without the legally required premarket authorization that applies to "new tobacco products."