MD Smoke Electronic Cigarette – FDA Warning Letter, Aug 27, 2019

On August 20, 2019, the FDA issued a Warning Letter to Mitch Darwish regarding the website http://www.mdsmoke.com. The FDA's Center for Tobacco Products reviewed the website and determined that e-liquid products advertised and offered for sale or distribution to U.S. customers are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the e-liquid products are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act because their website advertising fails to include the required nicotine warning statement. Specifically, the website for products such as Blueberry, Cherry, Cigar, Coffee, Fruit Chocolate, Grape, Lemon, Menthol Tobacco, Peach, Strawberry, Tobacco, Vanilla, and Watermelon e-liquids did not display the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission also renders the products misbranded due to false or misleading labeling/advertising by failing to reveal material facts.

The letter requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-