In a landmark authorization, the U.S. Food and Drug Administration has allowed the marketing of three electronic nicotine delivery system (ENDS) products, taking the first step towards tobacco harm reduction and helping adult smokers to switch over to lesser harmful products.
“This is a huge step forward. It would allow the adult smokers the much- needed assistance in switching to tobacco harm reduction and opting for a smokefree future,” said Arshad Ali Syed, head of the Pakistan Alliance for Nicotine and Tobacco Harm Reduction (PANTHR).
A project of Alternative Research Initiative (ARI), PANTHR promotes innovative solutions for smoking cessation in Pakistan. While remaining committed to and supporting tobacco control efforts in Pakistan, especially Article 14 of FCTC, the alliance serves as a platform for advocating and promoting all innovative solutions for ending smoking whether counselling, NRTs, or harm reduction.
The three marketing authorizations under the FDA’s Premarket Tobacco Product Application (PMTA) pathway have been given to .J. Reynolds (RJR) Vapor Company, for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products said, “the manufacturer’s data
demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”
Under the PMTA pathway, manufacturers must 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. Additionally, the FDA 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. 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.
“The rigorous process shows that a smokefree future where smokers would be save from the dangers of tar and other chemicals,” Arshad said. He added the tobacco harm reduction should be the main plank of tobacco control efforts in Pakistan. “It would help to bring down smoking prevalence among adult smokers.”