SMOK APPEALS FDA MARKETING DENIAL ORDER TO U.S. COURT OF APPEALS FOR THE FIFTH CIRCUIT

Shenzhen IVPS Technology Co., Ltd., a Shenzhen, China-based manufacturer of market-leading electronic nicotine delivery system (“ENDS”) products, announced today that it has filed an appeal of FDA’s marketing denial order for six of its popular SMOK®-branded open-system electronic cigarette kits and associated replacement parts. The appeal, which was joined by a Dallas, Texas-based distributor of the subject SMOK products, was filed with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit.

On January 16, 2024, FDA announced via a press release that it had issued a marketing denial order on the premarket tobacco product applications for the subject open-system SMOK products because the applications supposedly “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” Shenzhen IVPS strongly challenges those assertions, as the company invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles.

Welfer Ouyang, Shenzhen IVPS’s CEO, stated as follows: “We are very concerned that, to justify issuing a marketing denial order on these open-system devices that are sold without any nicotine-containing e-liquid, FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products.”

Shenzhen IVPS also noted that FDA’s press release announcing the marketing denial order was misleading in its characterization of the supposed levels of youth use of SMOK products, as FDA claimed that the 2023 National Youth Tobacco Survey showed “11.3% of middle and high school students reporting past 30-day use of SMOK products.” In fact, the NYTS showed that only 7.7% of high school and middle school students reported past 30-day use of an ENDS product, and that, of those users, only 11.3% reported using a SMOK product, which amounts to fewer than 0.88% of all students surveyed, not 11.3%.

The United States Court of Appeals for the Fifth Circuit recently vacated two other marketing denial orders FDA issued to bottled e-liquid manufacturers in 2021, finding that FDA engaged in springing new study requirements on manufacturers months after they were required to file their applications without adequate notice or opportunity for the applicants to satisfy the new study requirements.

Media Contact: compliance@smoktech.com 

SOURCE SMOK