SMOK Appeals US FDA Marketing Denial Order

by | Jan 19, 2024

On January 18, SMOK announced that it had filed an appeal against the U.S. FDA’s marketing denial order for its SMOK brand open system Vape kits and related replacement parts to 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.”

SMOK strongly disputes these assertions by the FDA. The company invested more than $30 million in PMTA applications, produced a total of more than 600,000 pages of data, and collaborated with the world’s leading laboratories to conduct powerful studies of harmful and potentially harmful ingredients in gases. Sol testing, in vitro toxicology testing and toxicology analyses, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies.

SMOK 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 past 30-day use. SMOK products”. In fact, the New York Times revealed that only 7.7% of high school and middle school students reported using nicotine vape products for more than 30 days, and of those users, only 11.3% reported using SMOK products.


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