Shenzen IVPS Technology Co, the large Chinese vape manufacturer responsible for the hugely popular SMOK brand, has just been handed more than twenty MDOs (Marketing Denial Orders) by the FDA. The MDOs, which are given in response to PMTAs (Pre-Market Tobacco Applications,) mean that devices like the SMOK OSUB One and Nord 2 are now not legally allowed to be marketed or sold within the United States.
The application denials are apparently due to a lack of sufficient evidence to demonstrate that permitting the marketing of the products would be “appropriate for the protection of public health”. This ambiguous standard, a requirement of the 2009 Family Smoking Prevention and Tobacco Control Act, makes it difficult for vaping companies to receive product approval. Exactly how you prove that a product is appropriate for the protection of public health has been left, perhaps intentionally, unclear by the FDA.
The FDA’s Brian King said “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence.”
SMOK appeared as the sixth most recognizable brand to middle and high-school children in the 2023 National Youth Tobacco Survey, well behind the likes of Elf Bar, Vuse, and Esco Bar, but still relatively high on the list. Brand popularity wasn’t the reason given for the MDOs against these SMOK products, but rather that the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.”
The SMOK devices, cartridges, atomizers, and pods that have been denied marketing authorization include:
- SMOK OSUB ONE Device
- SMOK OSUB ONE RPM Cartridge
- SMOK RPM DC 0.8 Ω MTL Atomizer
- SMOK OSUB ONE RPM Cartridge 3 Pack
- SMOK RPM DC 0.8 Ω MTL Atomizer 5 Pack
- SMOK Nfix Device
- Nfix DC 0.8 Ω MTL Pod
- SMOK POZZ Device
- SMOK POZZ DC 0.8 Ω Pod
- SMOK RPM 40 Device
- SMOK RPM Empty Standard Cartridge
- SMOK RPM Empty Nord Cartridge
- SMOK RPM Mesh 0.4 Ω Atomizer
- SMOK Nord DC 0.8 Ω MTL Atomizer
- SMOK SCAR-P3 Device
- SMOK SCAR-P3 Empty RPM 2 Cartridge
- SMOK SCAR-P3 Empty RPM Cartridge
- SMOK PRM 2 Mesh 0.16 Ω Atomizer
- SMOK RPM Mesh 0.4 Ω Atomizer
- SMOK Nord 2 Device
- SMOK Nord 2 RPM Cartridge
- SMOK Nord 2 Nord Cartridge
This list includes some of SMOK’s most popular devices and is likely to be a considerable blow to the brands’ attempts to remain in the American market. Although the parent company can resubmit adjusted PMTAs for those products (at a considerable cost,) if the current trend continues, it is unlikely that vapers in the U.S. will be seeing a Nord 2 or SCAR P3 for sale in their local vape store any time soon.
Successful PMTAs, which are required for all existing and new vaping products even if they contain no nicotine, have proven to be almost impossible for many vape brands to obtain. The FDA suggests that of the 26 million applications received since 2020, 99% have been reviewed and processed, yet only 23 vaping products have been granted the right to be marketed and sold.