The e-cigarette industry has been hit hard by the recent outbreak of more than 2,300 cases of vaping-related illnesses and the 47 deaths connected to it. Companies like JUUL have halted advertising in the face of intense backlash and a handful of states have enacted temporary bans on flavored e-cigarette products and THC vapes in light of public health concerns. But R.J. Reynolds Vapor Co., manufacturer of the second-most popular e-cigarette in the U.S., isn’t backing down. Despite widespread health concerns over vaping, R.J. Reynolds claims its “Vuse” e-cigarette is safer than tobacco. And the company is seeking FDA approval for multiple Vuse products.
FDA Likely to Approve Closed-Pod Vaping Systems Like Vuse
Public health officials remain highly concerned about e-cigarette and vaping devices, especially as vaping continues to gain popularity among young people. But R.J. Reynolds Vape Co. still maintains that e-cigarette’s are safer than tobacco. And the company is looking for FDA approval to be able to make such a claim in its marketing materials.
Vuse e-cigarettes are the number two best-selling U.S. brand. R.J. Reynolds bills Vuse products as electronic nicotine delivery systems for adult consumers. The company wants to be able to market Vuse e-cigs as less risky than traditional tobacco products. But first, the FDA will need to give its go-ahead, and that involves measuring Vuse against a number of public health standards.
R.J. Reynolds has already taken the first major step toward that approval, with the FDA’s acceptance of the company’s 150,000 page application. The FDA will also conduct inspections of Vuse manufacturing facilities and the facilities and entities which conducted the studies cited in the application.
Despite the difficulty of the approval process, R.J. Reynolds is confident its Vuse products will meet FDA standards. The Centers for Disease Control investigation into vape-related illnesses and deaths has honed in on open-pod e-cigarettes and THC vape cartridges. But Vuse is a closed-pod system, and the CDC reports that only a small fraction of recent incidents have involved closed-pod e-cigarettes.
Can the FDA Protect Consumers from Dangerous E-Cigarette Products?
R.J. Reynolds’ objective to market its Vuse products as safer than tobacco highlights the ongoing battle over tobacco regulation in the United States. It also reveals how the FDA’s move to deregulate the industry has created an uproar among public health officials and anti-tobacco groups.
In August 2017, the FDA agreed to let flavored e-cigarette products stay in the market until August 2022 without FDA authorization or review. And in response, a coalition sued the FDA in March 2018, claiming the agency “deliberately abdicated” its responsibilities under the 2009 Tobacco Control Act. That lawsuit succeeded in bumping up the timeline to 2020. But with its application submission to the FDA, R.J Reynolds just bought itself another year of being able to market Vuse without authorization of its claims.
Back in October, lawmakers with the House Oversight and Reform Committee put pressure on R.J. Reynolds to limit and halt advertising of Vuse e-cigarettes. Congress can ask manufacturers to voluntarily stop advertising such products, but it lacks the authority to compel companies to do so.
The FDA has not commented on its review of Vuse. But the process will involve weighing the risks and benefits of Vuse to the population as a whole, and comparing that analysis to the risks of traditional cigarettes. “FDA will now review our scientific justification and determine the appropriateness of Vuse e-cigarette products against the public health standard.,” Reynolds American Inc. chief executive Ricardo Oberlander said in a statement.
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Source: Hight Times