shenzhen, china, January 19, 2024 /PRNewswire/ — Shenzhen IVPS Technology Co., Ltd., shenzhen, chinaThe company, the manufacturer of market-leading electronic nicotine delivery systems (“ENDS”) products, today filed an appeal of the FDA's denial of sale order for six of its popular SMOK® branded open system e-cig kits and related replacement parts. announced that it had been submitted. . This appeal includes texas, dallasBased at a reseller of eligible SMOK products, new orleans louisianaUnited States Court of Appeals for the Fifth Circuit, based in .
upon January 16, 2024Through a press release, the FDA stated that the application “failed to provide sufficient data to characterize ingredient delivery, product stability, and product abuse” for premarket tobacco product uses for the subject open system SMOK products. announced that it had issued a marketing refusal order. responsibility. ” Shenzhen IVPS strongly disputes these claims as the company invested excess amounts. $30 million In its applications, totaling well over 600,000 pages, we collaborated with the world's leading research institutions to perform aerosol testing of potent and potentially harmful ingredients. in vitro Includes toxicology testing and analysis, accelerated testing and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the product's potential abuse liability profile.
Welfer OuyangThe CEO of Shenzhen IVPS said: “We are justified in issuing a no-sale order for these open system devices that are sold without any nicotine-containing e-liquids. In order for the FDA to Use Isolation data obtained from testing devices with e-liquid formulations that the product instructions specifically warn are not compatible with these devices supports overwhelmingly positive toxicology of these products. and safety profile. ”
Shenzhen IVPS also noted that the FDA's press release announcing the no-sale order was not intended for SMOK products, as the FDA claimed that “11.3% of middle school and high school students reported” in the 2023 National Youth Tobacco Survey. It was found that the characterization of the level of youth use was misleading. His use of SMOK products in the past 30 days. In fact, the NYTS found that only 7.7% of high school and middle school students reported using an ENDS product in the past 30 days, and only 11.3% of those users reported using a SMOK product. , which showed that he is less than 0.88%. % of all students surveyed, not 11.3%.
US The Fifth Circuit Court of Appeals recently vacated two other no-marketing orders the FDA issued to bottled e-liquid manufacturers in 2021, affirming the agency's involvement.Edited in SpringImposing new research requirements on manufacturers months after the manufacturers were asked to submit their applications without adequate notice or opportunity for applicants to meet the new research requirements.
Media contact: compliance@smoktech.com
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