SMOK Appeals FDA Denial in Fifth Circuit Court

The manufacturer of SMOK vaping products and a Texas vape distributor have appealed FDA marketing denial orders (MDOs) issued earlier this week for 22 SMOK hardware products. The petition for review was filed yesterday in the Fifth Circuit Court of Appeals by lawyers for Shenzhen IVPS Technology Co., Ltd. and Dallas-based Worldwide Vape Distribution.

The appeal charges the MDO is arbitrary, capricious, an abuse of discretion, and not supported by substantial evidence. The plaintiffs ask the court to set aside and vacate the FDA denial, and to stay FDA enforcement until the court decides the case.

On Jan. 3, the same appeals court granted petitions for review for two e-liquid manufacturers appealing their MDOs. The court ordered new FDA reviews of premarket tobacco applications (PMTAs) submitted by Triton Distribution and Vapetasia, and dressed down the agency for its reckless regulatory practices.

The first FDA marketing denial for open-system vapes

The SMOK products rejected by the FDA are all open-system products, meaning that they don’t contain e-liquid. The tiny list of FDA-authorized vaping products does not include any open-system products, including devices, accessories or bottled e-liquid.

Until now, the FDA has avoided decisions on PMTAs for standalone hardware, focusing instead on prefilled pod- and cartridge-based devices, and disposables, which are usually sold in convenience stores and gas stations. Open-system devices are preferred by vape shop and online consumers.

The MDO raises interesting questions about the FDA Deeming Rule, in which the agency claims regulatory authority over not just nicotine-containing vape products, but also standalone vaping devices and their “components and parts,” all of which the FDA defines as “tobacco products.”

Open-system vaping products can also be used with CBD e-liquid and other products that don't contain nicotine and are not regulated by the FDA Center for Tobacco Products.

SMOK spent $30 million on PMTAs

SMOK said in a press release that it spent over $30 million completing PMTAs for the denied products, producing more than 600,000 pages of evidence, including “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, CEO of SMOK’s parent company Shenzhen IVPS Technology Co., Ltd., said, “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 cherrypicking 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.”

SMOK also pointed out in its press release that the FDA made misleading claims about youth use of SMOK-brand products, implying that many more middle and high school students chose SMOK than actually did.

Dozens of vaping manufacturers have challenged MDOs in federal courts, and many cases are still in progress.