Agency says companies have not provided ‘sufficient evidence’ that any possible public health benefits of e-cigarettes outweigh the risks
FRIDAY, Aug. 27, 2021 (HealthDay News) — Three small electronic cigarette makers have been told by the U.S. Food and Drug Administration to stop selling their flavored products.
The orders issued Thursday to JD Nova Group LLC, Great American Vapes, and VaporSalon require them to remove 55,000 existing or planned flavored products from the market or risk enforcement.
In the first FDA marketing denials for e-cigarettes, the agency said the three companies’ applications did not provide “sufficient evidence” that any possible public health benefits of their products for adult smokers outweigh the “threat posed by the well-documented, alarming levels of youth use” of flavored vaping products. The FDA specifically noted flavors such as Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal sold by the companies.
“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement. “Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision making about which products may be marketed.”
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