FDA issues marketing denial for 6,500 flavored e-cigarettes
The U.S. Food and Drug Administration (FDA) on Friday issued marketing denial orders to 10 companies that collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products.
The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action.
Any company that wants to legally market a new tobacco product in the United States must receive a written marketing order from FDA. But if the health regulator deems it unfit for public health, it issues a marketing denial order.
The FDA named eight of these companies that received the denial orders, which include Imperial Vapors LLC, Savage Enterprises, and Big Time Vapes.
However, the FDA said it was not disclosing the names of the other two companies to protect potential confidential commercial information.
The FDA added the premarket tobacco product applications (PMTAs) submitted for a variety of flavored e-cigarette products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for public health.
Some of the flavors denied by the health regulator include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.
Altria Group Inc’s NJOY has six e-cigarette products that have received full approval from the FDA.
Juul, another e-cigarette maker in which Altria was a former investor, is still seeking approval for its products. The FDA last year briefly banned Juul’s products but put it on hold and agreed to reconsider after the company appealed.
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