In an op-ed published today in the Boston Globe, a day in which FDA announced it’s intention to issue regulations to ban menthol cigarettes, PHAI’s executive director and president consider what the next steps in tobacco prevention should be.
Gottlieb and Daynard suggest that:
The FDA should also remove menthol flavored e-cigarettes from the market. If these products, favored by youth, are on the market to help menthol smokers switch to e-cigarettes, this will not be necessary once menthol cigarettes are gone.
Nicotine must be carefully regulated so that cigarettes are no longer addictive. The evidence is that very low nicotine cigarettes will help smokers to quit and will not result in them increasing smoking to compensate.
The nicotine strength in American e-cigarettes is more than double the maximum allowed in Europe. There is no public health rationale for e-cigarettes to be this addictive and the FDA should regulate them accordingly.
Finally, the end of the public health crisis caused by tobacco industry products will only come when we plan to phase out their sales entirely to establish a tobacco-free generation. Brookline, Massachusetts is the first community in the nation to approve this policy and is poised to prohibit sales of any tobacco products to anyone born on or before January 1, 2000. This slow phase-out is a reasonable and permanent way sunset these lethal and addictive products permanently. It should be widely adopted.
On Friday, July 28, 2017, U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb unveiled a revamped approach to tobacco product regulation in an announcement that surprised tobacco companies, investors, and the public health community in equal measure. The goal, as articulated by Gottlieb, will be to regulate products so as to encourage migrating existing consumers from the most lethal combustible tobacco products (i.e., cigarettes) to non-combustible products lower on the continuum of risk. This approach is known as “harm reduction.” The keystone will be to promulgate product standards so that cigarettes deliver insufficient nicotine to users to create or sustain addiction so that current nonsmokers never start and current smokers either quit or switch to non-combustible tobacco product that present a lower health risk.
This idea, while somewhat radical, is not new. It had been a topic of discussion at the American Medical Association in the mid-1990s. Congress gave the FDA regulatory authority over tobacco in 2009 with the Family Smoking Prevention and Tobacco Control Act of 2009 (“Tobacco Control Act”). It prohibited the agency from banning cigarettes or from banning nicotine. The law does, however, explicitly allow for the potential reduction of nicotine in cigarettes to any level above zero. The Public Health Advocacy Institute at Northeastern University School of Law produced a white paper on this approach in 2009 and proposed further research on the policy, but enthusiasm at the agency and the Executive Branch was lacking. Northeastern University Distinguished Professor, Richard A. Daynard, characterized non-addictive cigarettes in the New York Times as one of two important strategies that could end the cycle of addiction, disease, and death from tobacco products.
Research to date, including a $50 million research project funded by the National Institute on Drug Abuse, have produced preliminary results supporting the notion that very low nicotine cigarettes will lead to fewer cigarettes smoked and reduced toxic exposure to consumers. So long as the nicotine levels are very low, compensatory smoking behaviors such as inhaling more deeply and smoking greater numbers of cigarettes do not seem to generally occur. Some of these preliminary results were presented at Northeastern University School of Law in 2014 by a Principal Investigator of the grant, Dorothy Hatsukami, at PHAI’s conference, “Accelerating Tobacco Endgame Strategies in the United States.”
Another important tool that the FDA can use is to issue rules pertaining to the use of flavors in tobacco products. While the Tobacco Control Act banned the use of characterizing flavors other than mint or menthol in cigarettes, concerns around the role of flavors in tobacco initiation have intensified in recent years. “Little cigars,” which closely resemble cigarettes, are available in a range of child-friendly flavors. E-cigarettes, likewise, have been criticized for offering fruit and candy flavors that would seem to appeal to children.
The question of exempting menthol flavored cigarettes from the flavor ban has been extremely controversial. The Tobacco Control Act, it was thought, would not have garnered the votes needed to pass Congress were a menthol cigarette ban included. Rather, the law specified that an expert committee must be convened by FDA to study the issue and issue a report on the health impact of menthol as a characterizing flavor in tobacco products.
The resulting reports concluded that although menthol itself did not contribute to the toxicity of tobacco products, it tended to anesthetize the lungs in a way that facilitates smoking initiation by youth and frustrated cessation efforts. Further, mentholated cigarettes have been historically marketed in a way that targets African Americans. Almost 90% of African American smokers prefer menthol cigarettes, which is the most robust sector of the cigarette industry in the United States. The company that produces the menthol market leader, Newport, was recently acquired by R.J. Reynolds which, in turn, was acquired by British American Tobacco this year. Reportedly, much of the value sought in these acquisitions derived from the Newport brand and the value of menthol cigarettes.
To date, the FDA has taken no action on mentholated tobacco products. Chicago and San Francisco have passed ordinances restricting sales of menthol tobacco products. San Francisco’s ordinance, which passed in July of 2017, is a total ban on all flavored tobacco product sales, including menthol.
The FDA announced that it will soon release three Preliminary Notice of Proposed Rulemakings seeking public and stakeholder comment on: 1) pros and cons of nicotine reduction strategies; 2) role of characterizing flavors, including menthol, in youth initiation and as a means to attract smokers to non-combustible tobacco products with less risk; and 3) potential health risks and use patterns of premium cigars.
Non-combustible products such as electronic nicotine delivery systems including e-cigarettes and emerging “heat-not-burn” products would be likely alternatives to non-addictive cigarettes as would nicotine replacement therapies such as the gum and patch. While this harm reduction approach has many supporters in the public health community, it would have the likely effect of perpetuating the commercialized recreational use of nicotine long into the future.
Since the FDA began regulating tobacco products in 2009, almost every substantive regulatory effort has been met with litigation. This includes 2 lawsuits challenging a host of the law’s provisions; challenges to the legal legitimacy of the report FDA issued about menthol; a successful First Amendment challenge to regulations for graphic cigarette warning labels; and a dozen or so lawsuits challenging the agency’s regulation of e-cigarettes and cigars.
This litany of litigation has, to this point, slowed or partially derailed the agency’s regulatory agenda and has drawn the criticism of many in the public health community. The FDA’s announcement marks a new and more aggressive regulatory vision for tobacco. Many questions remain. Is the scientific evidence base sufficient to justify this new approach? What will be the effect of inevitable legal challenges from manufacturers and smokers? What are the health impact of non-combustible tobacco products to users and non-users? How did the political environment in the Executive Branch change to allow for this new strategy to emerge and will it last?
With so many questions remaining and so many potential rules to enact, the timeline for the FDA to implement its new regulatory approach is uncertain. Based on past experience, it would be reasonable to expect that it may be a decade or more until cigarettes are non-addictive. Until then, there will be an effort by the tobacco industry to attract millions of consumers to new, less dangerous, but still addictive tobacco products.
Author – Public Health Advocacy Institute
2010 Verdict Reflected Juror Outrage at Handouts of Free Cigarettes to Children.
Marie Evans at the age Lorillard began handing her free samples of Newports
The SJC today unanimously rejected Lorillard Tobacco Co.’s attempt to evade liability in a case brought by Willie Evans, whose mother Marie died in 2002 at the age of 54. Testimony at trial reported that while Marie was a child growing up in the Orchard Park housing project in the Roxbury neighborhood of Boston, she received free samples of Newport cigarettes. Marie, who first received the free samples of Newport cigarettes when she was 9 or 10 years of age, became addicted by the time she was 13, according to lawyers for her son, Willie Evans.
Newport, which is Lorillard’s best-selling brand of cigarettes and contains menthol, has been heavily marketed toward the African-American community, a fact that was highlighted at the 2010 trial.
In today’s ruling the Massachusetts high court upheld the compensatory damages of $35 million but reversed a punitive damages award of $81 and sent the case back for a new trial on the issue of punitive damages. The Court found that the jury was not adequately instructed about the negligence claims pertaining to design and marketing.
However, the key finding was that the Court upheld the jury’s finding that Newport cigarettes were not fit to be sold in Massachusetts (breaching the implied warranty of merchantability).
Lorillard could have and should have sold a safer alternative product that did not addict Ms. Evans and cause her lung cancer. The Court wrote:
We decline to place addictive chemicals outside the reach of product liability and give them special protection akin to immunity based solely on the strength of their addictive qualities. . . . Rather, we conclude that, in determining as a matter of law whether the evidence presented at trial was sufficient for a reasonable jury to conclude that the plaintiff’s proposed design was a reasonable alternative to the defendant’s product, we must determine whether the design alternative unduly interfered with the performance of the product from the perspective of a rational, informed consumer, whose freedom of choice is not substantially impaired by addiction. Applying that standard to the evidence in this case, we conclude that a reasonable jury could find from the evidence presented that a low tar, low nicotine cigarette constituted a safer reasonable alternative to Lorillard’s Newport cigarettes. (emphasis added)
By “low tar, low nicotine cigarette,” the Court is not referring to brands that were deceptively marketed as “lights.” It means cigarettes that do not addict and expose consumers to an array of carcinogens. As a matter of law in Massachusetts, any cigarette sold that addicts or maintains the nicotine addiction of consumers is defective. That would include just about every cigarette sold in Massachusetts.
Mark Gottlieb, Director of the Public Health Advocacy Institute (PHAI), which is based at Northeastern University School of Law in Boston, was delighted with today’s ruling: “Florida has been a hotbed of tobacco litigation in recent years because cigarettes there are considered defective as a matter of law for a former class of addicted smokers. About 8,000 cases are awaiting trial in Florida. After today’s ruling, this is now the law in Massachusetts with the important difference that it applies to every plaintiff victim of cigarette industry products. I expect many more cases here to help to address the suffering of victims like Marie Evans who were needlessly addicted in their youth to a deadly product.”
Edward L. Sweda, Jr., Senior Attorney for PHAI, added that, “It is high time that Lorillard is forced to pay the Evans family for the suffering caused by its outrageous practice of giving away deadly and addictive Newport cigarettes to children near housing projects. This company’s profiteering for decades on the backs of African Americans must come to an end and today’s ruling is an important step in that process.”
The Public Health Advocacy Institute at Northeastern University School of Law and its President, Dick Daynard have long sought to make an impact on public health and policy by thinking outside the box. In an op-ed piece published in today’s New York Times, Daynard looks at an endgame for cigarette-caused addiction, disease and death in the U.S. and focuses in on two complementary but independent regulatory strategies.
The first strategy, available to the FDA under its authority granted in 2009 by Congress through the Family Smoking Prevention and Tobacco Control Act, is to reduce the nicotine content of cigarettes (and cigarette-like products) to non-addictive levels. Reducing nicotine yields of tobacco products (to anything above zero) is specifically mentioned in the law and, given strong evidence that it would benefit public health, there is nothing stopping the FDA from taking this bold step. While many smokers will quit if cigarettes do not deliver sufficient nicotine to maintain their addiction, others may chose to use tobacco products with higher levels of nicotine. But because cigarettes are, far and away, the most toxic product available for delivering nicotine, making them non-addictive is the only responsible thing to do. It will help existing smokers to quit or move to less dangerous sources of nicotine, stop smoking experimentation by youth from becoming a deadly addiction, and dramatically reduce non-smokers’ exposure to tobacco smoke. Public polling, while limited, consistently shows significant support, even by smokers, for reducing nicotine in cigarettes.
The second strategy relies on states and even communities regulating the sales of cigarettes under the principles of a proposal that has gained some traction outside of the U.S., called the Smokefree Millennial Generation. I feel it should be named in honor of the late Dr. C. Everett Koop who once challenged America of become a smokefree nation by 2000. The idea is that if a person’s birth year begins with the number “2,” that person shall not purchase cigarettes (or little cigars or other cigarette-like products). The legal authority for states and communities to enact such sales restrictions was clearly stated in the legislation that granted the FDA regulatory authority over tobacco (although communities could be preempted in some states). This proposal would gradually phase out smoking, beginning with the Millennials in 2018, wherever it was enacted. As more states adopted this policy, there would be fewer places willing to sell cigarettes to 18-year-olds who are unlikely to have the mobility to get a sufficient cross-border supply to initiate or maintain addiction.
While each of these strategies would face likely legal challenges that would delay but probably not overturn the regulatory policies in question, as well as public relations and implementation challenges, the time has finally come to put an end to smoking and smoking-caused disease by focusing narrowly on the highest impact policies that would dramatically reduce smoking rates in a decade. It is PHAI’s hope that today’s op-ed will generate a discussion and support among public health and tobacco control leaders so we can work together to truly achieve our shared goal of sharply reducing preventable death and disease. Eliminating smoking may seem way outside the box, but it is the best place to start.
In response to a request for comments, PHAI urges the FDA to prioritize smoked tobacco nicotine reduction as a potentially highly effective tool to mitigate the public health cost of smoking. Please see our complete Comments (pdf).