"Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults … get nicotine from alternative and less harmful sources, needs to be the cornerstone of our efforts."—Dr. Scott Gottlieb
At once bewildering and promising, the U.S. Food and Drug Administration’s (FDA’s) new position on tobacco, driven by new Commissioner Dr. Scott Gottlieb, focuses on an almost fantastical notion of re-engineering traditional, combustible cigarettes to reduce their levels of nicotine, while at the same time offering an apparent reprieve for e-cigarettes and the vaping community.
The FDA essentially answered a question with a question, stating a new direction by posing a scientific unknown. And while the tobacco industry’s reaction was ultimately one of uncertainty, the mainstream conclusion was: The FDA just bought the category time.
Speaking on an Aug. 3 investor call, Donnie Smith, vice president and controller for El Dorado, Ark.-based Murphy USA Inc., expressed confidence that the FDA would follow through on its promised review of “real science and understanding the unintended consequences of any regulation.”
The process, he said, would probably take a while. So by working with manufacturers over that period, Smith said retailers such as Murphy would be “well-positioned to participate in the new products, their introduction and work in the context of the regulations as they get developed and modified over time.”
Since the November 2016 election, retailers wondered how the FDA would handle tobacco issues under the Trump administration. Then in midsummer, Gottlieb issued an extended document focused on breaking nicotine addiction as a central strategy.
In addition, Gottlieb said alternatives to combustible cigarettes, such as electronic cigarettes, are in need of further public discussion and research, subsequently extending deadlines for manufacturers to submit their new-product applications to at least four years from now, as opposed to August 2018.
Making cigarettes less addictive or nonaddictive and moving from what many see as an “abstinence only” environment to one of reduced risk “needs to be the cornerstone of our efforts,” Gottlieb said. “And we believe it’s vital that we pursue this common ground.”
The FDA surmises that “lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit,” Gottlieb said in a statement. “Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating addiction crisis that is threatening American families.”
In announcing its goal toward low-nicotine options, the agency said it intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential benefits and possible adverse effects of lowering nicotine in cigarettes.
“Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly regulated products,” Gottlieb said. “To be successful, all of these steps must be done in concert and not in isolation.”
Discussing the FDA’s statement in a NATO newsletter, Thomas Briant, executive director of the Minneapolis-based tobacco-outlet association, said part of the FDA’s goal is to develop a “product standard” that would regulate the properties of a lower-nicotine combustible cigarette. He pointed out that Congress in 2009 prohibited the FDA from lowering the nicotine level to zero.
Similar to the public-commentary period on lower-nicotine cigarettes, the FDA is also going to initiate a public-comment period on the dangers of e-cigarette batteries, youth access to e-liquid and the potential of e-cigarettes to be less harmful than traditional cigarettes.
“A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes,” Gottlieb said.
The agency said it intends to issue a new enforcement policy “shortly,” with new deadlines pushing back the date when manufacturers must submit applications for new products. Instead of 2018, products such as cigars, pipe tobacco and hookah tobacco have a deadline of Aug. 8, 2021, and e-cigarettes or vapor products have a deadline of Aug. 8, 2022. Also, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
Prior to his confirmation on May 9, Gottlieb called the potential of alternatives to smoking traditional combustible cigarettes a “public health virtue,” alluding to at least an openness to electronic cigarettes and other so-called “risk-reduction” products.
Now as the FDA’s new commissioner, Gottlieb may potentially bring a more sympathetic view of risk reduction than Mitch Zeller, director for the FDA’s Center for Tobacco Products (CTP), Rockville, Md. (See Gottlieb vs. Zeller) Zeller has often sided with anti-tobacco groups regarding risk reduction as the FDA and the CTP have rolled out policies governing tobacco products.
Gottlieb is now Zeller’s boss. “Certainly, it would be a great opportunity if Scott Gottlieb’s ascension at the FDA leads to Mitch Zeller leaving the agency,” says Gregory Conley, president of the American Vaping Association, Hoboken, N.J. In the past, Conley has called Zeller out for initially appearing to be open to risk-reduction arguments, only to announce later regulation that’s more cost-prohibitive for the industry.
According to Vapes.com, Gottlieb could “fire Zeller on the spot,” but both have ties to pharmaceutical companies, which could cloud matters because that industry has stakes in cessation products. E-cigarettes have threatened that business in recent years.
Whether Zeller stays, Gottlieb’s effect on the tobacco category may be muted at first. One stumbling block to his confirmation was investments he made or has been involved in regarding medical and pharmaceutical concerns. Some have argued he would be ineffective against major drug companies in combating the nation’s opioid epidemic.
More important for tobacco was his investment in Kure Corp., an e-cigarette manufacturer and retail franchise based in Charlotte, N.C. Because of his ties to vaping, Gottlieb recused himself from commenting on vaping for a period of one year.
Such a recusal may compromise efforts to get e-cigarettes out from under the FDA’s current “deeming” rule, which places a rigorous and expensive application-and-approval process on all products put on the market since Feb. 15, 2007—encompassing virtually all vaping products on the U.S. market today.
Anti-tobacco groups met Gottlieb’s most recent announcement with agreement and skepticism. Matthew Myers, president of the Campaign for Tobacco-Free Kids, Washington, D.C., said in a statement that Gottlieb’s proposed agenda “represents a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and the death and disease it causes in the United States.”
At the same time, Myers was critical of the FDA’s decision to delay compliance deadlines. “This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public-health oversight,” he said.
Altria Group Distribution Co., Richmond, Va., called the agenda a “meaningful step forward in developing a comprehensive regulatory policy that acknowledges the continuum of risk. We supported FDA regulation because, among other things, it created a framework for communication about reduced-harm products,” the company said in a statement.
The process outlined by the FDA will “allow all stakeholders the opportunity to participate in a science- and evidence-based regulatory framework, which is transparent, predictable and sustainable,” the Altria statement said. “It’s important to understand that any proposed rule such as a nicotine-product standard must be based on science and evidence, must not lead to unintended consequences and must be technically achievable.”
A spokesperson for Winston-Salem, N.C.-based Reynolds American Inc. and its operating companies said, “[We] are encouraged by FDA Commissioner Dr. Scott Gottlieb’s comments recognizing tobacco harm-reduction policies and the continuum of risk for tobacco products. Gottlieb’s comments regarding nicotine and menthol do not come as a surprise to us. We are well prepared and look forward to participating in a thorough process to develop a comprehensive plan for tobacco and nicotine regulation.”
The Question of Reducing Nicotine
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 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,” Rushton 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 (NIDA), 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.
The company has been in meetings with the FDA’s Center for Tobacco Products and is in the process of resubmitting a Modified Risk Tobacco Product (MRTP) application for its Brand A cigarettes. If successful, 22nd Century will be able to say the product features a 95% reduction in nicotine.
“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 … associated with reduced consumption and potentially a loss of addiction.”
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