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FDA Denies Marketing of SMOK E-Cigarette Products: What You Need to Know

On January 16, 2024, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs), refusing to allow Shenzhen IVPS Technology Co., Ltd to sell twenty-two (22) SMOK brand e-cigarette products in the United States. The denied products include e-cigarette devices, pods, atomizers, and cartridges, sold without e-liquid. This means they could be used with any e-liquid that is inserted by the user, including tobacco-flavored and non-tobacco flavored e-liquids. After reviewing the company's premarket tobacco product applications (PMTAs), FDA found they did not provide enough evidence to meet the necessary public health standard.

Dr. Brian King, Director of FDA’s Center for Tobacco Products (CTP), stressed the need for science-based review of products to demonstrate that the new tobacco product is appropriate for the protection of the public health. FDA's decision means these products cannot be sold or distributed in the United States. Manufacturers, distributors, and retailers who continue to sell them risk enforcement action.

Navigating FDA regulations can be daunting for businesses. We are here to guide you through them, ensuring compliance with regulations and protecting your business interests. If you have any concerns or questions about FDA regulations or other challenges affecting your business, do not hesitate to reach out. Give our office a call today at (917) 546-6997, we would be happy to speak with you.

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