Chinese E-cigarette Brand SMOK Appeals U.S. FDA Marketing Denial Order

Chinese e-cigarette brand SMOK appeals U.S. FDA marketing denial order

On January 18, the SMOK brand entity announced that it had appealed against the U.S. FDA's marketing rejection order for its SMOK brand and had submitted it to the U.S. Court of Appeals for the Fifth Circuit.

On January 18, Shenzhen Avipus Technology Co., Ltd. (hereinafter referred to as "Avipus Technology"), the main company of the SMOK brand, announced that it has rejected the US FDA's marketing of its SMOK brand open system e-cigarette kits and related replacement parts. An appeal of the order was filed with the U.S. Court of Appeals for the Fifth Circuit.

Previously, on January 16, the US FDA issued a press release stating that the agency had issued a marketing denial order for pre-market tobacco product applications for open system SMOK products, involving 22 products, because these applications "failed to provide sufficient data." to characterize ingredient delivery, product stability, and product abuse."

Avipex Technologies strongly disputes these assertions by the FDA. The company invested more than $30 million in the PMTA application, produced a total of more than 600,000 pages of data, and collaborated with the world's leading laboratories to conduct powerful harmful and potentially harmful studies. Aerosol testing for hazardous ingredients, in vitro toxicology testing and toxicology analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies.

Ivypus also noted that the marketing denial order referenced in the FDA press release was misleading in describing expected levels of youth use of SMOK products, as the FDA claimed that the 2023 National Youth Tobacco Survey showed that "11.3% of middle school and high school students reported that in the past 30 Use SMOK products every day". In fact, the New York Times showed that only 7.7% of high school and junior high school students reported using nicotine e-cigarette products for more than 30 days, and of those users, only 11.3% reported using SMOK products.
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