FDA Rejects PMTAs for 22 SMOK Devices, Pods, and Coils

The FDA was formally asked by the American Vapor Manufacturers Association (AVM) to either recall the press release or provide a correction.
FDA Rejects PMTAs for 22 SMOK Devices, Pods, and Coils
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FDA Declares The FDA declares metal coils and batteries to be tobacco products
FDA Allegedly Distorts FDA Allegedly Distorts Survey Findings to Support Ban on SMOK Products

 

With today's action, the FDA moved closer to outlawing open-system vaping hardware that isn't sold with e-liquid. Refillable e-liquid from any manufacturer, including those without nicotine or with non-nicotine compounds like CBD, can be used with open-system products.

Marketing denial orders (MDOs) were issued by the FDA for six vaping devices under the SMOK brand as well as for 14 replacement coils and pods that were utilized in the illegal devices. These gadgets are as follows:

  • SMOK OSUB ONE
  • SMOK Nfix
  • SMOK POZZ
  • SMOK RPM 40
  • SMOK SCAR-P3
  • SMOK Nord 2

The product cannot be sold or distributed in the United States after receiving a marketing denial order, and if the order is broken, the producer could face enforcement action from the FDA. In other cases, stays allowing items to stay on shop shelves were granted to the several dozen vape producers who challenged MDOs in federal courts in the United States.

Shenzhen IVPS Technology Co., Ltd., a Chinese company, received the MDOs. One of the most well-known and established brands in the Chinese vaping market is SMOK, which is owned by IVPS.

The FDA declares metal coils and batteries to be tobacco products

The majority of vaping hardware is defined as "components and parts of a tobacco product" by the FDA in the 2016 Deeming Rule, which gave the agency regulatory authority over vaping products. As a result, manufacturers are required to justify the products' existence to the FDA before they can be sold, even if they don't contain any nicotine or e-liquid.

Premarket tobacco applications (PMTAs) from independent hardware manufacturers have not received attention from the FDA up to this point; instead, it has concentrated on prefilled devices, especially disposables, which are typically found in convenience stores and gas stations.

The agency's action today makes it quite evident that it plans to pursue products that are only popular among customers of open-system hardware devices and bottled e-liquids in the vape shop/online market sector.

FDA Allegedly Distorts Survey Findings to Support Ban on SMOK Products

There are two reasons why the agency is justifying this action: First off, "unauthorized" items can be utilized with the products, just like any other e-liquid. No bottled e-liquids in any flavor or vaping products with flavors other than tobacco have been approved by the government. In addition, the government claims that many young people use the SMOK items that are prohibited.

Due to these factors, the FDA "determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health," as stated in a news release from the agency.

According to a news statement from the FDA, teens who participated in the National Youth Tobacco Survey often said that SMOK is their preferred brand. According to the FDA, 11.3% of middle and high school students reported using SMOK products in the previous 30 days, making SMOK "the sixth most commonly reported brand among current youth e-cigarette users."

The NYTS results were misquoted by the agency, nevertheless. Not 11.3 percent of all pupils, but 11.3 percent of vaping kids named SMOK. Less than 1% of all students polled gave the term SMOK.

The FDA was formally asked by the American Vapor Manufacturers Association (AVM) to either recall the press release or provide a correction.

At 4:20 p.m., the time this piece went to press, the online press release still hadn't been updated.

men - 1 About Author
"

Kevin S. is an experienced vape writer and collector of VaporBoss. I have been writing about disposables, e-liquids, and vape coils for half a decade now. With a commitment to accuracy and clarity, I guide readers through the maze of information, providing valuable insights for both beginners and experienced vapers. My writing not only demystifies the technical jargon, but also delves into the cultural nuances, trends, and regulations that shape the ever-evolving vaping community.

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