Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.
The four companies are Mighty Vapors LLC doing business as Ovo Manufacturing and Distribution, Liquid Labs USA LLC doing business as Likido Labs USA, V8P Juice International LLC and Hookah Imports Inc.
“Today’s actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found," Acting FDA Commissioner Ned Sharpless said. "Our work in this area has already resulted in a number of companies removing products from the market. The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products. We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to, sold to, or used by kids. It is critical that we remain vigilant in our efforts to stem the increase in use and nicotine addiction in children driven by e-cigarettes, which threatens to erase the years of progress we’ve made combatting tobacco use among kids.”
Each company is required by the FDA to respond as to how they will address the FDA’s concerns, including dates the products are discontinued and how the companies will comply with the FD&C Act.