Reduced-nicotine cigarettes may soon be in U.S.
Decaffeinated coffee and reduced-sugar soft drinks have long been around. Now, according to a small biotechnology company, it’s time for low-nicotine cigarettes.
Altria Group Inc. and RJ Reynolds Tobacco told regulators two years ago that such a product might not be possible. But their claims may be upended after 22nd Century Group Inc., a Williamsville, N.Y., company, went before the Food and Drug Administration this month seeking to market cigarettes with 95% less nicotine than conventional ones.
22nd Century has for years made Spectrum cigarettes, which have varying levels of nicotine and have been used for governmentfunded research on tobacco and addiction.
It won authorization from the FDA in December to start selling a brand to the public, which will be named VLN. The next step is to get permission to market the cigarettes as a low-nicotine alternative.
“The product greatly reduces your nicotine consumption, and it smells, burns and tastes like a conventional cigarette,” John Pritchard, the company’s vice president of regulatory science, said in a phone interview before the Feb. 14 FDA meeting.
His company aims to disrupt the nearly $100-billion U.S. tobacco industry by marketing its cigarettes as a tool to wean adult smokers off addictive nicotine.
Pritchard said he planned to present data showing that former smokers or those who never smoked have low interest in the product.
A nod from the FDA would give 22nd Century a useful marketing tool that Marlboro maker Altria lacks. Altria is selling Philip Morris International’s IQOS device, which heats but doesn’t burn tobacco, in the U.S.
But the agency still hasn’t approved an application to market it as a reduced risk compared with cigarettes.
22nd Century said its application should be easier to evaluate than Altria’s, given the body of research on its Spectrum cigarettes, which were used as part of $100 million of federal grants to study lownicotine cigarettes.
The company also says its central claim — that its cigarettes have 95% less nicotine content — is easier to verify than the reduced-risk designation that Altria is seeking for IQOS. It hopes to start selling the cigarettes by the second quarter.
After the FDA declared in 2018 that it intended to establish rules on maximum nicotine levels in cigarettes, Altria said it wasn’t clear whether substantially reducing cigarettes’ nicotine “is technically achievable” or whether it would lead to reduced smoking.
Reynolds, meanwhile, said the industry is “at least 20 years away from producing tobacco at a commercial scale that would meet the range of low-level nicotine discussed.” 22nd Century counters that by citing the FDA’s own assessment of a plan to lower nicotine to the levels found in VLN products. The agency says the restrictions would lead to 5 million additional adult smokers quitting within a year of the plan going into effect, while averting more than 8 million tobacco-related deaths by the end of this century.
The company holds patents on methods of producing cigarettes by targeting different genes and enzymes in tobacco plants, and makes them from genetically engineered tobacco.
It is also working on non-GMO tobacco lines.
When the new coronavirus, COVID-19, first broke out, China’s healthcare system was unprepared. Hospital waiting rooms were so packed with prospective patients that hundreds more had no choice but to line up outside. Many waited several hours, only to be turned away and urged to self-quarantine. More troubling, experts say, is that the chaos of this initial surge likely did more to spread the disease than stop it.
The same fate awaits us here if the new virus becomes a global pandemic.
Hospitals in the United States are already so overburdened, and their staffs so overworked, that one bad flu season is enough to push them over capacity. Just two years ago, during a particularly bad season in California, patients seeking treatment for the flu instead found themselves in “war zones.” Hospitals turned away ambulances, imported nurses from elsewhere and erected parking lot tents when they ran out of beds. Surgeries had to be canceled and hospitals ran out of supplies.
If the new coronavirus gains momentum here, infecting thousands, the outlook would be even grimmer. To be sure, we are better prepared than we were for the last coronavirus outbreak in 2009. Our hospitals now have pandemic plans to ensure that enough equipment, protective gear and administrative controls are available to deal with a surge of new patients.
But, on their own, these measures are not enough.
First, we must do more to make sure that if an outbreak occurs, we can keep and treat people where they are safest — in their homes. That will require leveraging or boosting the telehealth capabilities of local clinics to enable remote diagnosis of emergent coronavirus cases. Such virtual consultations would divert pressure away from hospitals and limit the transmission of infections in crowded waiting rooms.
Second, we must ensure that any added costs of protection and prevention are covered for patients. Currently, payment by insurance companies for virtual urgent care is not federally mandated, and many plans don’t cover it. Without a guarantee that their costs will be covered, patients may still head to hospitals to avoid the fees.
Finally, we must prepare our hospitals and our health systems now for future crises even greater than the one we may face with COVID-19. This latest coronavirus is, by all appearances so far, more benign than some previous ones. Though it is highly transmissible, it has a low mortality rate, with the vast majority of those infected surviving whether they are treated at home or in a hospital.
But there will come a time when a coronavirus outbreak or other biothreat emerges that is more lethal and widespread than anything previously seen. Our hospital-centric health system isn’t equipped to handle such a crisis. We must forge a new path toward a health system of distributed care, where patients receive care where they need it most — not just in hospitals, but in the home and community.
The United States is home to some of the world’s best health providers and technological innovations. But we still hold to an antiquated notion that advanced healthcare is best delivered in hospitals.
Countries like Singapore have shown that distributed care can be achieved on a national scale, and if they can do it, so can we.