| Section | Link to Section |
|---|---|
| PMTA Rejected | PMTA for Suorin Air rejected |
| Refills and The Blu PLUS | Refills and the blu PLUS+ device receive MDOs. |
The FDA has rejected applications for the commercialization of refill cartridges, a cigalike-style device that uses a rechargeable cartridge, and a well-known refillable pod vape. The FDA issued its first marketing denial orders (MDOs) for open-system goods devoid of nicotine and e-liquid at the end of the same week that the MDOs were issued.
Since assuming regulatory responsibility over vaping products in 2016, the FDA has only authorized seven vaping devices and tobacco-flavored refills for each. Since Brian King, the current director of the FDA Center for Tobacco Products, took up the position in July 2022, the agency has not approved a single vaping device.
No non-tobacco flavors, refillable (open-system) products, or bottled e-liquid have been approved by the FDA. Every FDA-approved product is produced by a subsidiary of major tobacco companies.
PMTA for Suorin Air rejected
Premarket tobacco applications (PMTAs) for the Suorin Air device—a refillable pod vape well-known for its thin profile—and its empty refillable pod have been refused, the FDA said in a news statement today. Shenzhen Youme Information Technology Co. Ltd., the parent firm of Suorin, submitted PMTAs, but the agency stated that they "lacked sufficient evidence regarding abuse liability."
The organization also mentioned that 3.8 percent of middle and high school students who reported smoking e-cigarettes in the previous 30 days reported using Suorin-brand products, according to results from the 2023 National Youth Tobacco Survey (NYTS). (In contrast to its earlier this week announcement addressing the use of SMOK products by minors, the FDA opted to phrase its claim in a clearly comprehensible manner.)
Like the SMOK products that the FDA rejected on Tuesday, the Suorin Air is devoid of nicotine and e-liquid. The FDA's crusade against vaping appears to be entering a new phase with the release of the SMOK and Suorin products combined. Up until recently, the government has prioritized prefilled devices and bottled e-liquids over judgments about PMTAs for open-system items.
Refills and the blu PLUS+ device receive MDOs.
Additionally, the FDA declared that all blu PLUS+ products—including the device batteries and refill cartridges with various identified tobacco and menthol flavors—were denied approval. Additionally, MDOs were granted for refill cartridges in other, unidentified flavors that have not been available in the United States since January 2020, when the FDA designated flavored pod and cartridge-based vapes as a top enforcement priority.
One of the most well-liked vaping products in the early days was the blu e-cigarette, which has been modified to become the blu PLUS+. In 2012, Blu became the first vaping startup to be acquired by a tobacco giant, Lorillard. Tobacco firms were not involved in the vaping industry prior to it.
A subsidiary of Imperial Brands, the old Imperial Tobacco, Fontem US, LLC, the maker of blu, is accused by the FDA of "failing to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information."Furthermore, the application failed to present enough proof that the flavor-infused new products would help adult smokers quit entirely or significantly cut back on their cigarette consumption, outweighing the harm to children.
The organization also mentioned NYTS data regarding middle and high school students' use of the blu brand, pointing out that 6.0 percent of respondents said they had used a blu product.
For the majority of Myblu refill pods and its pod-based Myblu gadget, Blu also received MDOs in 2022. The FDA was ordered to perform a new review of the business's PMTAs for the myblu device and tobacco-flavored pods after the company filed an appeal with the Circuit Court of Appeals for the District of Columbia.
