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The FDA rejects PMTAs for 22 SMOK devices, pods, and coils

The FDA rejects PMTAs for 22 SMOK devices, pods, and coils

The FDA has advanced in its efforts to prohibit open-system vaping hardware that is sold without e-liquid. Open-system products, which are refillable and enable consumers to use them with e-liquid from various manufacturers, including non-nicotine options or those containing ingredients like CBD, are targeted.

The FDA has issued marketing denial orders (MDOs) for six SMOK-brand vaping devices, along with 14 pods and replacement coils associated with these prohibited devices. Here is the list of the affected devices:

  • SMOK Nfix
  • SMOK RPM 40
  • SMOK Nord 2

Following the issuance of a marketing denial order, the product is prohibited from being sold or distributed in the U.S., and the manufacturer may face FDA enforcement actions for any violations of the order. Numerous vape manufacturers have contested MDOs in U.S. federal courts, often securing stays that permit their products to continue being available in stores.

The marketing denial orders were directed at Shenzhen IVPS Technology Co., Ltd., a company located in Shenzhen, China. IVPS is the owner of the SMOK brand, a well-established and widely recognized name in the Chinese vaping industry.

The FDA asserts that batteries and metal coils are considered tobacco products

The 2016 Deeming Rule, through which the FDA assumed regulatory control over vaping products, categorizes most vaping hardware as "components and parts of a tobacco product." This designation requires manufacturers to provide justifications for their products to the agency before they can be sold, even if the products do not contain nicotine or e-liquid.

Historically, the FDA has overlooked premarket tobacco applications (PMTAs) from standalone hardware manufacturers, concentrating instead on prefilled devices, including disposables typically found in convenience stores and gas stations.

The recent decision by the FDA indicates a shift in focus, signaling the agency's intention to scrutinize products predominantly popular in the vape shop/online segment of the market. This segment caters to consumers of open-system hardware products and bottled e-liquids.

The FDA inaccurately cites its own survey results to support the justification for banning SMOK products

The FDA's rationale for taking action against SMOK products is two-fold: firstly, the products can be used with any e-liquid, including those the agency has not authorized, and secondly, it claims a significant number of youth use the denied SMOK products. According to an FDA press release, the agency states that the applications lacked sufficient evidence to demonstrate that permitting the marketing of these products would be appropriate for the protection of public health.

In the press release, the FDA asserts that teenagers participating in the National Youth Tobacco Survey frequently identified SMOK as their preferred brand. The FDA reports SMOK as the sixth most commonly mentioned brand among current youth e-cigarette users, with 11.3% of middle and high school students indicating past 30-day use of SMOK products. However, it appears that the agency misquoted the NYTS results, as it was 11.3 percent of students who vaped that named SMOK—not 11.3 percent of all students. In reality, fewer than one percent of all surveyed students named SMOK.

The American Vapor Manufacturers Association (AVM) has formally requested that the FDA recall the press release or issue a correction.

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