The Food and Drug Administration (FDA) has laid out a new roadmap for tobacco regulation, which on one hand could be bad news for traditional cigarettes, but on the other hand, could be good news for innovative products like vapor and heat-not-burn.
Central to the FDA's new approach to tobacco control is the belief that products such as e-cigarettes and cigars should not be used by kids. Specifically, the FDA postponed the requirement that such products be approved by the agency.
The FDA'sannouncement was welcomed by the Campaign for Tobacco-Free Kids as "a bold and comprehensive vision".
This product would fit in nicely with the FDA's stringent nicotine rollback.
Regulatory procedures are also being revised and made more transparent and predictable for manufacturers of these products.
Gottlieb said other issues may arise, such as a black market in high-nicotine cigarettes. "We intend to be fully engaged throughout this process". British American Tobacco, which owns brands such as Camel, Lucky Strike and Newport, fell almost 9%. If the nicotine were removed, or reduced to non-addictive or minimally addictive levels, the FDA is betting that far fewer people would end up smoking cigarettes and suffering the consequences.
"Dr. Gottlieb's comments regarding nicotine and menthol do not come as a surprise to us".
In this approach, nicotine and the problem of addiction are placed at the center of the tobacco regulation efforts by the agency.
Regions outside the USA present additional potential for 22nd Century to partner or licensed the company's low nicotine cigarette platform.
According to the US FDA, cigarette smoking is responsible for more than 480,000 deaths per year in the United States, as well as an estimated USD 300 billion dollars in direct health care and lost productivity costs.
It is clear that Big Tobacco names like Altria Group, British American Tobacco, Reynolds American, Japan Tobacco, and Imperial Tobacco will be closely watching this news in the coming months.
In addition, regulations that outline the details on the information the agency expects to be included in the Modified Risk Tobacco Product (MRTP), Premarket Tobacco Applications (PMTAs), and reports to demonstrate Substantial Equivalence (SE) are meant to be released by the agency. ".We believe it's more likely that the FDA approves PM's application to commercialize iQOS in the USA, as well as its modified risk application".
According to Greg Conley, president of the American Vaping Association, 99 percent of vape products now available would have been banned next year if the 2018 deadline remained in place. "This is by no means a flawless fix".
Each cigarette can contain between 8 mg and 20 mg of nicotine, which is as addictive as heroin, according to the American Heart Association.
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