A group of public health organizations, a parent, and a pediatrician filed a lawsuit against the Food and Drug Administration on July 14, challenging a recent agency guidance allowing the sale of e-cigarette and nicotine pouch products without premarket authorization.
The FDA guidance, issued in May, pertains to two types of tobacco products: oral nicotine pouches and electronic nicotine delivery systems (ENDS), such as e-cigarettes, vape pens, and hookah pens. Generally, tobacco products must secure premarket authorization to be legally sold in the United States. This involves a manufacturer submitting a premarket tobacco product application (PMTA) with scientific data demonstrating that the product is appropriate for the protection of public health, the agency said at the time.
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