FDA Denies PMTAs For Suorin Air And Blu PLUS+


0
FDA Denies PMTAs For Suorin Air And Blu PLUS+
FDA Denies PMTAs For Suorin Air And Blu PLUS+

The FDA has denied marketing applications for a popular refillable pod vape, and also a rechargeable cartridge-based cigalike-style device and refill cartridges. The marketing denial orders (MDOs) came at the end of the same week during which the agency issued its first MDOs for open-system products that contain no e-liquid or nicotine.

The FDA has authorized just seven vaping devices, along with tobacco-flavored refills for each, since it assumed regulatory authority over vaping products in 2016. The agency hasn’t authorized a single vaping product since current FDA Center for Tobacco Products Director Brian King assumed the post in July 2022.

The FDA has authorized no products in non-tobacco flavors, and no refillable (open-system) products or bottled e-liquid. All FDA-authorized products are made by subsidiaries of major tobacco companies.

The FDA announced today in a press release that it has denied premarket tobacco applications (PMTAs) for the Suorin Air device—a refillable pod vape popular for its slim profile—and its empty refillable pod. The agency said PMTAs submitted by Suorin parent company Shenzhen Youme Information Technology Co. Ltd. “lacked sufficient evidence regarding abuse liability.”

The agency also noted that 2023 National Youth Tobacco Survey (NYTS) results showed that 3.8 percent of middle and high school students who reported using e-cigarettes in the past 30 days reported using Suorin-brand products. (The FDA chose to word its claim in an easily understandable way, unlike its statement earlier this week regarding youth use of SMOK products.)

The Suorin Air, like the SMOK products the FDA denied on Tuesday, contains no e-liquid or nicotine. Together, the SMOK and Suorin products seem to represent a new phase in the FDA’s campaign against vaping. Until now, the agency has put off decisions on PMTAs for open-system products, and focused instead on prefilled devices and bottled e-liquids.

The FDA also announced denials for all blu PLUS+ products, including the device battery, and refill cartridges in several named tobacco and menthol flavors. MDOs were also issued for refill cartridges in other, unnamed flavors, which have been unavailable in the U.S. since the FDA made flavored pod- and cartridge-based vapes an enforcement priority in January 2020.

The blu PLUS+ is an updated version of the blu e-cigarette that was among the most popular early vaping devices. Blu was the first independent vaping company to be purchased by a tobacco company (Lorillard) in 2012. Before that, tobacco companies had no presence in the vaping market.

According to the FDA, blu manufacturer Fontem US, LLC (a subsidiary of Imperial Brands, the former Imperial Tobacco) “failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information. In addition, the applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.”

The agency also cited NYTS results about blu brand use by middle and high school students, noting that 6.0 percent of surveyed students reported using a blu product.

Blu also received MDOs for its pod-based myblu device and most myblu refill pods in 2022. The company appealed the denials to the Circuit Court of Appeals for the District of Columbia, and last August the court ordered the FDA to conduct new reviews of the company’s PMTAs for the myblu device and tobacco-flavored pods.


Like it? Share with your friends!

0

0 Comments

Your email address will not be published. Required fields are marked *