Larry A. Watts 
The Food and Drug Administration used a familiar strategy on Friday by licensing a limited number of e-cigarette products from a major tobacco maker — NJoy LLC — while denying the vast majority of submissions.
This time, the FDA cleared two new NJoy tobacco products through the premarket tobacco product application pathway. These are its tobacco-flavored disposable e-cigarettes in Daily rich 4.5% and Daily extra rich 6% — the percentages are for nicotine content.
Meanwhile, the FDA has issued marketing denial orders “for several other Daily e-cigarette products. Any such products that remain on the market must be removed or the FDA may take enforcement action. »
The premarket enforcement standard requires the FDA to consider the risks and benefits of products to the general population, including users and nonusers.
Applications for two other menthol-flavored daily products are still under review by the FDA.
The authorization allows these products to be legally marketed in the United States
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The FDA again warned that with previous approvals of e-cigarettes from other manufacturers, “although this action allows the sale of these specific products in the United States, it does not mean that these products are safe and that they are not FDA approved.”
“All tobacco products are harmful and potentially addictive. Those who do not use tobacco products should not start.
On April 27, the FDA cleared NJoy Ace styles: its closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods: Classic Tobacco 2.4%, Classic Tobacco 5%, and Rich Tobacco 5%.
The latest Nielsen analysis of convenience store data, covering the four-week period ending May 21, determined that NJoy has a 3% market share.
Meanwhile, Juul from RJ Reynolds Vapor Co. was at 35.1% market share and Juul from Juul Labs at 33.1%.
See mixed results
On May 12, the FDA cleared RJ Reynolds Vapor Co. for six Vuse Vibe and Vuse Ciro e-cigarette products.
However, the FDA has issued marketing refusals “for several other Vuse Vibe and Vuse Ciro e-cigarette products.”
These approvals are for two Vuse Vibe power packs and its original 3.0% tobacco style tank, and two Vuse Ciro power packs and its original 1.5% tobacco style cartridge.
“For each device, two versions of the power units have been cleared to reflect the different battery manufacturers described in the company’s applications,” the FDA said.
For the multiple Vuse products that have been denied, “any of these products currently on the market must be removed or the FDA may take enforcement action.”
British American Tobacco Plc, parent company of Reynolds, said in a May 12 statement that “these clearances represent the broadest portfolio of marketing clearances granted to any company in the United States.”
Reynolds said applications for its menthol flavors “remain under review and may remain in the market pending an agency decision.
“The FDA has issued a denial for applications of other flavors. These flavored vapor products, per industry guidelines published by the FDA, are not currently marketed or sold in the United States. We are reviewing the decision of the FDA regarding these applications to determine next steps.
BAT added that Vuse Alto styles remain under review and will continue to be available to adult nicotine users. The Vuse Alto PMTA was submitted almost a year after Vuse Solo, and five months after Vuse Vibe and Ciro,
“These apps share basic science,” BAT said.
The FDA said that for authorized Vuse products, “chemical testing was sufficient to determine that the overall levels of harmful and potentially harmful constituents in the aerosol of these products are lower than those of burnt cigarette smoke.”
The FDA said it “will closely monitor how these products are marketed and take action if necessary if the company fails to comply with applicable legal or regulatory requirements, or if there is a significant increase in the number of non-compliance. -smokers – including young people – using these products.
Previous authorizations
In October, the FDA on Tuesday issued a landmark decision by approving the Reynolds Vapor’s tobacco flavor of the closed Vuse Solo electronic nicotine delivery system, its power supply and two replacement cartridges.
However, the FDA at that time rejected submissions for 10 flavored Vuse Solo products. He said at the time that he was “still evaluating” the company’s request for menthol-flavored products for Vuse Solo.
Reynolds said in an October statement that the FDA orders “confirm that Vuse Solo products are appropriate for the protection of public health, highlighting years of scientific study and research dedicated to ensuring that adult consumers of nicotine ages 21 and older have access to innovative and potentially less harmful alternatives to traditional tobacco products.
“With respect to the FDA’s limited concerns regarding these applications that are not currently on the market, we are carefully considering the agency’s analysis and decision.
The latest approval comes after Reynolds Vapor filed its PMTA submissions for several Vuse products on October 11, 2019. The FDA agreed to review the submissions on December 1, 2019.
On March 25, the FDA cleared several tobacco-flavored e-cigarette products for Japan Tobacco Plc’s Logic brand.
Given that Logic holds a tiny 0.9% market share – albeit fifth overall – in Nielsen’s latest convenience store report, the ripple effect of FDA approval may prove crucial. or irrelevant.
Electronic Nicotine Delivery System, known by the acronym ENDS, includes the Logic Vapeleaf, Logic Power and Logic Pro brands of Logic Technology Development LLC, including the devices.
However, the FDA has also issued market denial orders to Logic for several other ENDS products, signaling that these products must be removed from the market or the agency can take enforcement action.
