The Food and Drug Administration issued a landmark ruling Tuesday in approving an R.J. Reynolds Vapor Co. electronic-cigarette product as appropriate to market to smokers from a public-health standpoint.
The FDA’s order covers the tobacco flavor of the Vuse Solo closed electronic nicotine delivery system, its power unit and two replacement cartridges.
“As the RJR Vapor Co. submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S.,” the FDA said in its news release.
However, the FDA rejected submissions for 10 flavored Vuse Solo products. It said it “is still evaluating” the company’s application for menthol-flavored products for Vuse Solo.
Reynolds said in a statement that the FDA’s orders “confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers age 21+ have access to innovative and potentially less harmful alternatives to traditional tobacco products.”
“Regarding FDA’s limited concerns on those applications not currently on the market, we are carefully studying the agency analysis and decision.
Vuse is the No. 2-selling e-cigarettes in the U.S. with a 33.3% market share, according to the Sept. 25 Nielsen survey of convenience store sales. Top-selling Juul was at 41%.
The Vuse Solo products are the first to be approved by the FDA through the daunting regulatory gauntlet known as the premarket-tobacco product application process.
“For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products,” according to the FDA’s news release.
“While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved.’ All tobacco products are harmful and addictive and those who do not use tobacco products should not start.”
The FDA declined to identify the 10 flavored products it rejected, citing “potential confidential commercial information issues.”
“These products subject to a marketing denial orders for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement.”Long process
The approval comes two years and one day after Reynolds Vapor made its PMTA submissions for multiple Vuse products on Oct. 11, 2019. The FDA agreed to review the submissions on Dec. 1, 2019.
The FDA said e-cigarette manufacturers are required to “demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health.”
“These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes.
“The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies.”
The FDA said it considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, called the approval “an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation.”
The FDA ruling drew mixed reactions from industry observers, anti-tobacco and anti-smoking advocates.
Some praised the ruling in an it’s-about-time manner.
Some agreed with the ruling, but lamented that the FDA chose to approve a Big Three tobacco manufacturer’s product, while denying and rejecting thousands of PMTA applications and millions of vapor products from smaller e-cigarette makers in recent months.
Others said it’s likely that the ruling will prompt a series of lawsuits from not only manufacturers whose PMTA submissions were rejected, but possibly Reynolds Vapor regarding the 10 denied Vuse flavors.
“I understand the challenges FDA/CTP has had to face given the court order, but in reading this I can only see more ligation coming,” said Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health.
“I will say that FDA/CTP was smart to act on the millions of other applications to get them off the table.
“Now, comes the more challenging part that goes to the heart of their actions,” Ballin said.
Seeing the FDA decision as confirmation that only top tobacco manufacturers would be able to successfully reach the finish line of the regulatory gauntlet was David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette and health studies.
“To date, it appears the companies least motivated to replace (traditional) cigarettes and the products least likely to be preferred alternatives to (traditional) cigarettes are the ones most likely to meet with FDA approval,” Sweanor said.
“That is better news for the cigarette business than it is for public health or consumer rights.”
Matthew Myers, the outspoken president of the Campaign for Tobacco-Free Kids, offered an uncharacteristic brief response to the FDA decision.
“While it is a positive step that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as legally permitted in Canada, the UK and Europe was authorized,” Myers said.
“Vuse products with this level of nicotine leave our nation’s youth at an undue risk of addiction.”
The ruling came just more than a month after the FDA did not meet a Sept. 9, 2021, federal court-ordered deadline for deciding which PMTAs to grant for e-cigarettes.
Multiple national media outlets have reported the FDA was seeking more time on the pivotal issue, particularly as it involves top-selling Juul.
E-cigarette manufacturers had to submit by Sept. 9, 2020, their PMTA in order to stay in the marketplace for at least another 12 months.
The FDA said Sept. 9 that “a small percentage of the more than 6.5 million products that were the subject of timely submitted applications still remain under review after Sept. 9.”
“We continue to work expeditiously on the remaining applications, many of which are in the final stages of review, and will issue our decisions on a rolling basis.”
On Tuesday, Zeller said that “we must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth.”
“We will take action as appropriate, including withdrawing the authorization.”