While the industry is focused on electronic cigarettes and “heat-not-burn” devices as go-to reduced-risk tobacco products, a plant-based biotech company suggests looking inward—inside the tobacco plant, that is.
Clarence, N.Y.-based 22nd Century Group Inc. is genetically manipulating tobacco plants to grow with lower-than-typical levels of nicotine, according to Dr. Paul Rushton, vice president of plant biotechnology. Consider the process as a river that ends in the production of nicotine. As a result of its patents, 22nd Century “owns certain parts of the riverbank,” he says. “And it’s at these points that we make adjustments to the river’s flow. We dam up sections or divert the river in order to reduce the production of nicotine to a trickle.”
The company’s science has already caught the eye of government agencies, which have been using 22nd Century products in their own clinical trials. The company has sold its Spectrum variable-nicotine research cigarettes to the National Institute on Drug Abuse, Bethesda, Md., which uses them as a clinical research tool. Some of its studies have examined the effect of reduced nicotine levels on cigarette addictiveness and cessation success.
To date, 22nd Century has sold more than 24 million Spectrum cigarettes to multiple buyers.
Founded in 1998, the company went public in 2011 and today employs about 70 in its main office, laboratories and manufacturing facility. In addition to Spectrum, 22nd Century has X-22, a smoking-cessation aid currently in development, and Brand A, a low-nicotine cigarette.
Through the summer, the company expects to be in meetings with the U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products, Silver Spring, Md., as it goes through the application process with its products. It is resubmitting a Modified Risk Tobacco Product application for its Brand A cigarettes. If successful, 22nd Century will be able to say the product features a 95% reduction in nicotine as compared to traditional cigarettes.
The company also has meetings scheduled with the FDA’s Center for Drug Evaluation and Research to discuss its X-22 product.
“The FDA has the authority to regulate nicotine directly,” Rushton says. “So the FDA could choose to set a maximum nicotine level for all cigarettes that clinical research has associated with reduced consumption and potentially a loss of addiction.”
The overall goal of 22nd Century is to help people quit smoking, says Rushton. Because of that mission, its path to market will most likely involve doctors prescribing smokers low-nicotine cigarettes as one way to kick the habit. While this path to market may appear to eliminate retail, low-nicotine products may nonetheless enter the marketplace in the future. And yet a wide gap exists between lab studies and retail success.
To have potential, new consumer products must first have unique and desirable qualities, says Don Burke, senior vice president of Management Science Associates Inc., Pittsburgh. Second, they need to establish a track record of sales success, either with a chain of stores or within a geographical region.
For most tobacco products, FDA “deeming” rules and the new-product application process is onerous and expensive. However, because 22nd Century seems to have a congenial relationship with many government agencies, the FDA may be less of an obstacle. Nonetheless, Burke says the FDA approval process is difficult and the product at retail will still have “communication restrictions.”
Government rules over tobacco packaging and advertising restrict what manufacturers can say about a product, making communicating the unique benefit of lower nicotine difficult. As a result, generating product trial will be that much harder, he says.
A second challenge would be jockeying for shelf space. C-store retailers are all too familiar with the limits on the backbar. Manufacturer contracts and the sheer amount of products available put shelf space at a premium.
With those challenges in mind, Burke sees the appeal of the prescription route to market.
“This would enable education through the doctor and guarantee availability to the consumer at a pharmacy,” he says. “Our own research at Management Science on vape shops has shown that the great majority of vape-shop consumers are looking for an alternative to smoking or to quit, and this product may provide an alternative to vaping with a more similar mouth and throat [feeling] to combustibles.”
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