FDA issues warning letter to e-cigarette manufacturer
The Food and Drug Administration (FDA) recently issued a warning letter to an e-liquid manufacturer for violations of the Federal Food, Drug, and Cosmetic (FD&C) Act, including marketing new tobacco products without authorization; marketing tobacco products with false and misleading advertising; and marketing unauthorized modified risk tobacco products. The FDA also noted in their letter that StemStix, the manufacturer receiving the warning, made false and misleading statements on its website that referenced FDA testing and marketed their e-liquid products as modified risk tobacco products without the required FDA order in effect. Finally, the warning letter also notes that StemStix violated the FD&C Act by marketing new tobacco products without authorization. As described in the letter, the products were introduced or modified after August 8, 2016 – the effective date of the final rule that extended the FDA’s authority to all tobacco products. The letter requests that StemStix provide a written response within 15 working days describing corrective actions and a plan for maintaining compliance with the FD&C Act.