| Section | Link to Section |
|---|---|
| FDAs Initial Rejection | FDA's Initial Rejection of Open-System Vapes in Marketing |
| SMOK Invests $30 Million | SMOK Invests $30 Million in PMTA Submissions |
FDA marketing denial orders (MDOs) for 22 SMOK hardware devices that were issued earlier this week have been challenged by the producer of SMOK vaping goods and a Texas vape distributor. The attorneys representing Dallas-based Worldwide Vape Distribution and Shenzhen IVPS Technology Co., Ltd. submitted the petition for review in the Fifth Circuit Court of Appeals Wednesday.
The appeal alleges that the MDO lacks sufficient evidence and is arbitrary, capricious, and an abuse of discretion. The plaintiffs request that the FDA's denial be overturned and that FDA enforcement be halted until the court renders a decision in their favor.
Two e-liquid makers who were appealing their MDOs were granted petitions for review by the same appeals court on January 3. The court chastised the FDA for its careless regulatory actions and ordered further reviews of the premarket tobacco applications (PMTAs) filed by Triton Distribution and Vapetasia.
FDA's Initial Rejection of Open-System Vapes in Marketing
All of the SMOK items that the FDA rejected are open-system products, which means that e-liquid is not a part of them. There are no open-system products on the short list of FDA-approved vaping items, not even gadgets, accessories, or bottled e-liquid.
The FDA has refrained from making decisions regarding PMTAs for standalone hardware up to this point, preferring to concentrate on disposables and prefilled pod and cartridge-based devices that are typically found in convenience stores and gas stations. Customers at vape shops and online prefer open-system devices.
The FDA defines "tobacco products" as nicotine-containing vape goods, but the MDO raises intriguing concerns regarding the FDA Deeming Rule, which asserts regulatory power over standalone vaping devices and their "components and parts."
CBD e-liquid and other non-nicotine products that are not subject to FDA Center for Tobacco Products regulation can also be used with open-system vaping systems.
SMOK Invests $30 Million in PMTA Submissions
"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" are just a few of the more than 600,000 pages of evidence that SMOK produced during the course of completing PMTAs for the denied products, according to a press release from the company.
According to Welfer Ouyang, CEO of SMOK's parent company Shenzhen IVPS Technology Co., Ltd., "We are very concerned that the FDA is cherry-picking 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 to justify issuing a marketing denial order on these open-system devices that are sold without any nicotine-containing e-liquid."
Additionally, SMOK noted in a news release that the FDA had made false statements regarding the use of SMOK-brand items by minors, suggesting that a much higher number of middle and high school pupils than really used SMOK.
