NJOY now has two devices that have received marketing approval from the U.S. Food and Drug Administration. The regulatory agency today issued marketing granted orders (MGOs) under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the MGO states. “The issuance of these marketing granted orders confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products.”
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the company to legally market them in the United States.
“Our finding that permitting the marketing of the new products is APPH does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A,” the MGO states. “Therefore, you may not make any express or implied statement or representation in a label, labeling, or through the media or advertising, that the new tobacco products specified in Appendix A are approved by FDA.”
The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. These are presumed to be for flavored products other than tobacco. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
The U.S. Food and Drug Administration today issued decisions on several R.J. Reynolds Vapor Company for several Vuse branded e-cigarette products, including the authorization of six new tobacco products through the premarket tobacco product application (PMTA) pathway. It’s the second and third Vuse branded device to garner an marketing approval. The company’s top selling Alto device is still under PMTA review.
The FDA issued marketing granted orders (MGO) to for the Vuse Vibe and Vuse Ciro e-cigarette devices and accompanying tobacco-flavored closed e-liquid pods. For each device, two versions of the power units were authorized to reflect different battery manufacturers described in the company’s applications. In total, the products receiving MGOs include:
2 Vuse Vibe Power Units
Vuse Vibe Tank Original 3.0%
2 Vuse Ciro Power Units
Vuse Ciro Cartridge Original 1.5%
The authorization allows the products to be legally marketed in the U.S. The FDA also issued marketing denial orders to R.J. Reynolds Vapor Company for multiple other Vuse Vibe and Vuse Ciro e-cigarette products, presumably for flavors other than tobacco. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
Neither the Vibe or Ciro device is popular with vapor consumers. Many consider the products old and outdated technically, unlike Njoy’s Ace device that was granted marketing orders in April. This marks the fourth and fifth vaping product brands (Vuse has 3 seperate products under the Vuse name) to receive an MGO from the FDA. In October 2021, the FDA issued its first marketing granted orders to Vuse Solo. In late March, the agency approved several Logic products for sale in the U.S.
Vuse Vibe / Photo: RJR Vapor
“Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
“The authorized Vuse products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke,” the FDA explained. “Further, data provided by the applicant demonstrated that participants who had used only the authorized Vuse Vibe and Vuse Ciro products had lower levels of exposure to non-nicotine HPHCs compared to the dual users of the new products and combusted cigarettes.
“Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”
The FDA said it considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, especially youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth – provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
The authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products, according to the agency. “The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products,” it wrote.
Credit: RJRVC
The FDA may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
Before making marketing decision documents available to the public, the FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the MGO webpage until after the order issuance date, according to the agency.
In the interim, to provide as much information as possible at the time of order issuance, the FDA is making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.
The U.S. Food and Drug Administration has received from the U.S. District Court of Maryland a 14-day extension to file the first premarket tobacco product application (PMTA) status reports required by the Court’s revised remedial order.
The plaintiffs in the case consent to the requested extension, according to the motion filed today.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states. “Also, a number of FDA employees helping to prepare the status report were out of the office on pre-planned leave last week, and a key FDA employee responsible for the status report will be out of the country on pre-planned leave next week.
“Defendants do not seek to modify any other deadline, and the FDA’s second status report would remain due July 28, 2022. Defendants are prepared to have this letter serve as their consent motion for a 14-day extension.”
Judge Grimm granted the motion. The new deadline for the first PMTA status reports are due May 16.
When the U.S. Food and Drug Administration issued marketing granted orders to the NJoy Ace and its tobacco-flavored e-liquid pods on April 26, the ACE became the first e-cigarette authorized by the FDA equipped with a ceramic coil. That coil is manufactured by FEELM, the flagship atomization tech brand belonging to Smoore International.
The Ace marketing orders mark the first approval by the FDA of a pod vaping product. It is also the first approval of any vaping product manufactured by a company that is independent of the tobacco industry.
Smoore is no stranger to seeing its products get marketing approval from the FDA. The first brand to receive marketing orders through the premarket tobacco product application (PMTA) pathway, Vuse Solo, is a strategic partner of Smoore, a Smoore representative explained to Vapor Voice. The second set of approved electronic nicotine-delivery system (ENDS) products, produced by Logic, are also manufactured by Smoore.
“NJoy has partnered with Smoore since 2009. The NJoy Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJoy Ace’s approval for sale fully showcases the harm reduction potential of FEELM ceramic coil,” the representative said. “According to the FDA, NJoy Ace is authorized for sale because ‘chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.’”
Based on PMTA requirements, Smoore established a comprehensive analytical testing and safety assessment system, including the vaping industry’s first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor, according to Smoore.
The company has also developed the third generation of in-house safety standards – Smoore 3.0 – that covers all of required PMTA tests, including for HPHCs listed by the FDA.
“The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH)”, said Dr. Long, director of the Smoore Analytical Testing and Safety Assessment Center. “The manufacturer must demonstrate the product’s potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction.”
Long said this could explain why all the FDA-authorized vaping products so far have been for tobacco flavors, and popular flavored products the agency has said promote youth use have been issued marketing denial orders. It is also an indication that vaping manufacturers should focus on “tobacco flavor reproduction and improve harm reduction performance” in order to be approved under the PMTA pathway.
According to Nielsen, for the two weeks ended April 9, 2022, Vuse has now surpassed Juul and become No.1 in U.S. e-cigarette sales with a market share of 35 percent. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils.
As the No. 3 player in the U.S., NJoy accounts for approximately 3.1 percent market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands and the first reports are due on April 29.
The FDA also found that the risk to youth initiation with NJoy’s Ace was outweighed by the benefit to adult smokers, warning that NJoy must comply with strict post-marketing requirements.
