Author Archives: Mark Gottlieb

About Mark Gottlieb

Mark Gottlieb joined the staff of the Public Health Advocacy Institute in 1993 after graduating from Northeastern University School of Law. His efforts have focused on researching tobacco litigation as a public health strategy as director of the Tobacco Products Liability Project, reducing the harm caused by secondhand tobacco smoke through a variety of legal and policy approaches, fostering scholarship using tobacco industry documents, and, more recently, examining legal and policy approaches to address obesity. He is the Executive Director of the Institute and lives in Cambridge, MA with his wife and three children.

PHAI Takes Action Against Puff Bar for Violating Massachusetts’ Ban on Flavored e-Cigarettes

CONTACTS:

Mark Gottlieb                                                             Meredith Lever
(617) 216-0779                                                            (617) 373-8066
mark@phaionline.org                                          meredith@phaionline.org

 

 FOR IMMEDIATE RELEASE

 Puff Bar Charged With Violating Massachusetts’ Ban on Flavored e-Cigarettes
In direct violation of state law, Puff Bar sells flavored, disposable e-cigarettes that appeal to teens

 BOSTON, MA (June 11, 2020) – Today, the Public Health Advocacy Institute (PHAI) at Northeastern University School of Law initiated action against Puff Bar and Cool Clouds Distribution, Inc., the makers and distributors of flavored, disposable Puff Bar e-cigarettes.

In its claim letter, PHAI alleges that Puff Bar e-cigarettes are sold in Massachusetts in clear violation of a November 2019 state law that prohibits the sale of all flavored e-cigarettes. Puff Bar has become extremely popular, eclipsing JUUL as the favored vape product among young people.

The claim is brought on behalf of 22-year old Juliana Larson of Medford and 33-year old Juliana Shulman-Laniel of Boston, both acting as testers for PHAI. In April, both testers purchased a flavored Puff Bar online through puffbar.com and had the product mailed to their homes in Massachusetts. The package was left at each tester’s doorstep without obtaining a signature.

“Apparently Puff Bar and Cool Clouds Distribution thought that nobody would notice or care that they have been selling flavored e-cigarettes here in blatant violation of Massachusetts law,” said Mark Gottlieb, Executive Director of PHAI. “We care and we will put a stop to it.”

According to PHAI, the sale and shipment of flavored Puff Bar e-cigarettes to Larson and Shulman-Laniel not only violated the state’s 2019 ban on flavored e-cigarettes, it also defied a Massachusetts Attorney General regulation that requires a delivery of e-cigarettes to be made only with a verified adult signature – two laws that aim to safeguard minors from dangerous products, such as Puff Bar e-cigarettes.

The claim also outlines multiple ways Puff Bar is being marketed to youth. A recent Puff Bar advertisement targeted youth and evoked coronavirus stay-at-home orders, stating: “We know that the inside-vibes have been . . . quite a challenge. Stay sane with Puff Bar this solo-break . . . . It’s the perfect escape from the back-to-back zoom calls, parental texts and WFH stress.”

Puff Bars are sold in 24 different flavors, including “blueberry ice,” “sour apple,” “strawberry donut,” and “mint chip” – flavors that make Puff Bars easily inhalable and attractive to teens. Puff Bar is designed to be sleek, cute, and discreet – appearing less like a nicotine delivery device and more like a harmless, fun accessory. At first glance, a Puff Bar may appear simply to be a USB drive, a design that enables young people to use Puff Bar devices surreptitiously without parents, teachers, or other adults knowing. As a disposable product, Puff Bar is also simple to use and relatively inexpensive – two features that make youth initiation especially easy.

“Puff Bar has recently flooded the e-cigarette market with a product that is designed and marketed to addict young people,” said Dick Daynard, President of the Public Health Advocacy Institute. “Puff Bar and Cool Clouds are selling Puff Bar products in Massachusetts in clear violation of state law, and we want to ensure that these dangerous products are no longer accessible to Massachusetts kids and teens.”

This claim is brought amidst a rising wave of national concern about Puff Bar products, including calls from Congress to close a federal loophole that has allowed for the proliferation of Puff Bar products amidst a nationwide ban on most e-cigarette flavors. The Massachusetts law, however, bans the sale of all flavored tobacco products with very limited exceptions.

If PHAI’s claim prevails, Puff Bar and Cool Clouds Distribution, Inc. will be required to cease their illegal sale of flavored Puff Bar e-cigarettes in Massachusetts.

###

The Public Health Advocacy Institute (PHAI) is a non-profit legal research center focused on public health law located at Northeastern University School of Law. In 2014, PHAI formed the Center for Public Health Litigation, a nonprofit law firm, which uses the civil justice system to improve public health by focusing on litigation targeting tobacco industry products, unhealthy foods, deceptive health marketing, and deceptive gambling practices.

 See the claim letter at claim letter at https://www.phaionline.org/wp-content/uploads/2020/06/2020.6.11-Puff-Bar-93A-Letter-final.pdf

PHAI’s Sarah Peck pens op-ed urging a stop to active shooter drills in schools

Sarah Peck, Director of PHAI’s #UnitedOnGuns initiative, recently authored an opinion piece published by the South Florida Sun Sentinel entitled: Profiting from protecting kids is wrong. Halt active shooter drills in schools. In it, Ms. Peck raises the concern, shared by many, that active shooter drills in schools can traumatize children.  She notes that 42 states have passed laws mandating these school drills and that a $3 billion industry has emerged to support implementation of these laws.

Such drills produced by for-profit companies are often designed to be realistic and may feature the sounds of gunshots and even the use of fake blood.  Ms. Peck shared one particularly disturbing example:

In one recent drill, teachers were lined up against a wall and shot — execution-style — with plastic bullets.

Such trauma-inducing practices are unacceptable in our schools, according to Ms. Peck.  The key, she maintains, is prevention, and she cites a program called “know the signs” as an example of an approach that may help identify kids in crisis who might pose a risk.

PHAI’s Sarah Peck pens op-ed supporting a federal “red flag” law

Sarah Peck, Director of PHAI’s #UnitedOnGuns initiative, recently authored an opinion piece published by The Hill entitled: A federal red flag law would save lives and give Trump a much needed win.  Ms. Peck notes that both red and blue states have enacted some version of these laws, also known as “extreme risk protection orders.”

The piece notes that “passing a federal red flag law could save lives if these incentives have the desired effect, especially in red states where gun deaths tend to be higher as a percentage of the population than in blue states.”  Ms. Peck stated that one study found that for every 10 risk orders issued, at least one suicide was prevented.

Read the full piece here.  It was published on November 17, 2019.

PHAI’s Gottlieb Pens Commentary: “How The Opioid Settlement Could Truly Help The Addicted”

On July 9, 2019. the WBUR (Boston NPR affiliate) opinion blog, Cognoscenti, published an opinion piece penned by PHAI’s executive director seeking to leverage any forthcoming settlement of the the more than 2,000 lawsuits pending against opioid pain manufacturers, their distributors, and their retailers to create an independent foundation to help coordinate a national response to the opioid epidemic.

The commentary, along with an amicus brief by PHAI and other public health organizations submitted to the court overseeing the litigation, considers the public health experience with the Master Settlement Agreement between the states and cigarette companies in 1998. It resulted in large payments from the settling defendants to the states that sued them. But those funds have not been adequately invested to develop the public health interventions and infrastructure needed to minimize the addiction, disease, and death caused by tobacco products.

While it is obviously important for the plaintiffs to recover damages as part of a settlement, the commentary urges that a portion of the settlement should be used to create a national foundation to fund local addiction recovery, provide overdose reversal medication, education, and fostering of promising demonstration projects. Such a foundation should also serve as a watchdog for the opioid medication and addiction treatment industries.

In the face of a crisis, no public health opportunity to address it should be squandered.

These Youth Will Not be Fuuled: An overview of the 2019 Altria Group Annual shareholders Meeting

By Edward L. Sweda, Jr., PHAI Senior Attorney

Howard A. Willard III, chairman and CEO of Altria Group
Howard A. Willard III

Five months before Howard A. Willard III presided for the first time over the Altria Group annual shareholders meeting in Richmond, Virginia, the company carried out a business plan that dominated the discussion at the meeting. On December 20, 2018, Altria Group announced it had spent $12.8 billion to purchase a 35% share of San Francisco-based Juul Labs, Inc. While that expenditure was not enough to buy an outright controlling interest in the company, it was more than enough to provide major controversy throughout the one-hour shareholders meeting on the morning of May 16, 2019.

Willard, Altria’s chairman and Chief Executive Officer, called 2018 a “strong year for the core tobacco business” and touted the JUUL investment, couching it as having been done to provide JUUL to adult smokers.
2018 was also a year that saw a dramatic surge in youth use of e-cigarettes, including JUUL. According to the 2018 National Youth Tobacco Survey, current e-cigarette use among middle and high school students rose dramatically between 2017 and 2018, with over 3.6 million young people currently using e-cigarettes in 2018. This marked a stark reversal of downward trends of such use in previous years.

In the shareholder meeting’s question and answer session, this author noted that, since the December purchase, “a federal class action lawsuit has been filed in Sarasota County, Florida, on behalf of a girl and her parents accusing JUUL of intentionally targeting teenagers for addiction and falsely denying doing so. The lawyers are using Florida’s anti-racketeering statute, alleging the company committed fraud, product liability and deceptive trade practices. In late April, the Public Health Advocacy Institute (for which I work) sent a demand letter to JUUL on behalf of three youths in Massachusetts. The three of them have become addicted to nicotine by using JUUL, and allege a violation of the state Consumer Protection Act. Specifically, the allegations involve breach of the implied warranty of merchantability regarding the design of the product to addicting non-smoking minors and also unfair marketing to teenagers.

“And the plaintiffs here are seeking the establishment of a program for the prevention and treatment of nicotine addiction in young people who use JUUL. And then, of course, just yesterday, the North Carolina Attorney General, Josh Stein, sued JUUL, saying that it had misrepresented the potency and danger of nicotine in its products. He is seeking injunctive relief, the disgorgement of profits and limiting some of the flavors used by JUUL.
“So my question is, what specific steps will Altria Group take to protect its $12.8 billion investment in JUUL by making JUUL less vulnerable to lawsuits of this type?”

Willard responded by acknowledging that, in December, Altria was aware of litigation against JUUL. Then he gave the standard assurance that “we are very committed to helping address the increase in e-vapor use and to encourage JUUL to make sure that their marketing is only to adult cigarette smokers.”

Another shareholder approached the issue of the $12.8 billion investment in JUUL from a different angle. Dr. Andrew Kramer cited three major criticisms of the deal “One that we paid too much. Two, more often, to me, is that here’s no path to control. And lastly, we’re restricted from distributing any other nicotine vaping systems that limits our – that prohibits our ability to build a diversified portfolio in that space.” Willard rejected Kramer’s analysis, calling the deal a “very attractive investment” for Altria.

Jonathan Chafee of Cattaraugus County, New York, asked why Altria had changed its position on raising the purchase age for tobacco products to 21 from two years earlier, when then-CEO Martin Barrington had said that local laws to raise the age to 21 would not help prevent youth use of tobacco because they would just travel to a community without such a law. Willard justified that switch in position by noting the rapid increase in youth use of e-vapor products in 2018.

Olivia Lang of New York asked what Altria sees as its ethical obligation to help their customers make better informed decisions about using products that harm their health. Willard cited the company’s “significant opportunity with products like IQOS and the new e-vapor products like JUUL to convert adult cigarette smokers down the risk continuum.”

Two shareholder resolutions were presented. The first one, supported by Sister Nora Nash, a sister of St. Francis of Philadelphia, called on Altria Group to disclose publicly the nicotine levels of the company’s cigarette brands. Sr. Nash said that “Altria needs to hear the calls of the thousands of people who will die this year from the horrible effects of smoking cigarettes and other products.”

The second resolution was presented by Cathy Rowan the director of socially responsible investments for Trinity Health and a member of the Interfaith Center for Corporate Responsibility. It called for a report on Altria’s policy and procedures governing direct and indirect lobbying, the company’s payments for such lobbying, Altria’s membership in and payments to any tax-exempt organization that endorses model legislation and a description of Altria’s oversight of this activity.

The first resolution garnered 3.9% YES votes, while the second resolution got 27.9% YES votes.

Young people from New York and Nebraska attended the meeting while many more were outside the Richmond Convention Center, chanting slogans such as “People Over Profits” and holding signs with messages including “We will not be FUULed! 1 Pod = 1 Pack”, “Who do you think these flavors are targeting? Fruit Medley” and ”13 is the average age of a new smoker.” Approximately 85 teen leaders came to Richmond to confront Altria Group management over the company’s outrageous conduct.
The youth who came to Richmond for this meeting were able to see through the multi-billion dollar corporate smokescreen and returned to their communities with the powerful messages they delivered to the management of Altria Group, Inc.

Lawsuit Demands Juul Fund Treatment for the MA Adolescents it Addicted

Today, the Public Health Advocacy Institute (PHAI) took the first step in launching a public health class action lawsuit in Massachusetts against Juul Labs, the makers of the most popular e-cigarette in the United States, for designing and marketing its product to appeal to and addict adolescents. This is the first such case brought against Juul in Massachusetts, and the first such lawsuit asking only one thing: for a court to require the company to fund a statewide clinical program for the treatment of nicotine addiction in young people who used Juul e-cigarettes.

While Juul Labs maintains that its product is intended to be used by adult smokers, the product’s design, in fact, caters to adolescents, whose brains are especially vulnerable to nicotine addiction. . Importantly for teens, Juul is designed to be used discreetly. To the untrained eye, a Juul e-cigarette may look simply like a USB drive. The design enables young people to use Juul surreptitiously without parents, teachers, or other adults even knowing. This product feature has helped Juul capture a massive teen market. “Kids use Juul everywhere,” said Matthew Murphy, now 19 years-old and one of the class representatives. “I knew kids who used Juul during class. I used it in my bedroom and my parents couldn’t smell it. They had no idea until long after I was hooked.”

Despite Juul’s claims that its e-cigarettes are intended solely for adult smokers hoping to switch from conventional cigarettes, the company engineered its sophisticated e-cigarettes to yield a physiological response and degree of nicotine ‘satisfaction’ which may actually exceed those of traditional cigarettes. Dr. Jonathan Winickoff is a professor of pediatrics at Harvard Medical School who treats Juul-addicted patients in his pediatric practice. “First of all, Juul is not a recommended or approved product for smoking cessation,” said Winickoff. “On the other hand, a teen can easily inhale a cigarette pack’s worth of nicotine in a Juul pod and, because the product’s design almost eliminates the body’s natural response to bronchial irritation caused by high doses of inhaled nicotine, addiction can occur very quickly”

Juul Labs went from a startup to being valued at over $30 billion in just over three years. Its business model depends on the sale of proprietary “pods” of liquid nicotine, including flavors like Mint, Mango, Fruit, and Crème that help make their e-cigarettes highly palatable and attractive to teenagers.

Marianne Savage is the mother of an addicted teen user of Juul and a class representative. “It is so hard seeing your child struggle with addiction,” said Savage. “It affected his grades, his social life, and his health. We have to fight hard to quit. The ordeal of Juul addiction caused my son a lot of pain and anxiety.”

Because best practices for treatment have yet to emerge, young people suffering from nicotine addiction caused by Juul have very few places to turn for help. “The goal of this lawsuit is to make sure that these kids and their parents in Massachusetts have a place to go to deal with this addiction,” said Mark Gottlieb, Executive Director of the Public Health Advocacy Institute. “Our non-profit law firm is taking on Juul Labs so that the company with the greatest responsibility for teenage addiction to e-cigarettes pays the cost for effective treatment for these young people.”

U.S. Virgin Islands Juries Deliver $113 Million Verdicts Against R.J. Reynolds to families of Deceased Newport Smokers

Newport Sample

The Public Health Advocacy Institute (“PHAI”) is pleased to announce that two tobacco lawsuits tried this month in St. Thomas, V.I., have concluded with verdicts totaling $113.3 million. The cases, Gerald v. R.J. Reynolds Tobacco Co. and Brown v. R.J. Reynolds Tobacco Co., were brought by two deceased smokers who had been hooked on Newport cigarettes as minors.

Rare Double Jury Trials

The cases were tried simultaneously, with both 6-person juries together hearing evidence common to both cases, and each separate jury hearing issues such as medical testimony that was specific to its case. These are the first tobacco cases to be brought in the U.S. Virgin Islands, the first tobacco cases tried together in this way, and among the largest verdicts achieved to date in individual tobacco litigation.

Comment of Tobacco Litigation Expert, Richard Daynard

PHAI President (and Northeastern University law professor) Richard Daynard commented:

“We are delighted that two juries independently concluded that Newport’s original manufacturer, Lorillard, and its successor company R.J. Reynolds,

Ms. Brown as a Teen

sold an unreasonably and unnecessarily dangerous product, marketed it by use of fraud, fraudulent concealment, and conspiring with the other major cigarette producers, and engaged in outrageous conduct with evil motive or in reckless or callous disregard of the rights or safety of others. The juries saw through the defendant’s con game: they addicted these two smokers through deceptive advertising and free samples, made thousands of dollars of profits from their subsequent purchase of Newports, and then tried to blame them for their ‘irresponsible’ decision to keep using these products. The smokers in these two cases were among the more than 20 million Americans who died of cigarette-caused deaths since the first Surgeon General’s Report in 1964.”

Lucien England

Background

Lucien England, the decedent in the Gerald case, began smoking Newport cigarettes as a child, when, as part of a nationwide marketing campaign, free samples of the cigarettes were hung from the doorknobs of the apartment building where he grew up. His death was caused by bladder cancer from smoking Newports.

Patrice Brown, the decedent in the Brown case, began smoking Newport cigarettes as a teenager, influenced by an advertising campaign that promoted Newports as having a “hint of mint,” and died from lung cancer after smoking those menthol cigarettes for decades.

PHAI is a public health research and advocacy non-profit located at Northeastern University School of Law in Boston. www.phaionline.org.

The case was brought by St. Thomas attorney Russell Pate, and tried by attorneys Michael Weisman and Gordon Rhea, with the assistance of PHAI attorney Meredith Lever. Mr. Weisman is Of Counsel with PHAI.  With the Brown case, Weisman reprised his 2010 success in the case of the late Marie Evans, in which a Boston jury awarded $71 million in compensatory damages and $81 million in punitive damages against the maker of Newport cigarettes for causing Evans’ premature death from lung cancer.  Ian A. McWilliams handled the audio-visual services for plaintiff’s exhibits in the Evans as well as the Virgin Island trials.

  • Brown v. R.J. Reynolds Tobacco Co. = $70 m compensatory + $12.3 m in punitive damages
  • Gerald v. R.J. Reynolds Tobacco Co. = $1 m compensatory + $30 m in punitive damages

 

PHAI Submits Comment Opposing Proposed School Food Nutrition Rollbacks

The U.S. Department of Agriculture (USDA) intends to issue a rule to weaken the school food nutritional requirements of the Healthy, Hunger-Free Kids Act of 2012.  The rule would allow flavored milk with added sugar, waive requirement to provide whole grains, and delay reductions of sodium levels in school foods. PHAI submitted a comment to USDA opposing this rollback of healthy eating requirements for school food.

In addition to evidence-based arguments opposing the proposed “flexibilities,” the comment notes our research in collaboration with the Berkeley Media Studies Group from 2016 that examined nutrition and policy proposals in 11 states. We found that two-thirds of relevant legislative or regulatory documents containing at least one policy argument (n=91) argued in favor of the 2012 guidelines. More than half of those arguments raised in favor of the guidelines argued that the guidelines will allow food service directors to provide healthier options or that the guidelines will benefit children’s health. In every state except Oklahoma and Texas, there were more pro-guidelines arguments than anti-guidelines arguments presented.

To learn more about this rollback and to comment (through January 29, 2018) visit this link at Regulations.gov.

This comment was primarily authored by our policy associate, Emily Nink, MS, and edited by Mark Gottlieb, JD.

View PHAI’s comment (pdf)

End of Year Appeal

This year, PHAI continued moving cases against Philip Morris and R.J. Reynolds to trial, went to court to tell Coca-Cola and the American Beverage Association to be honest about the link between sugar drink consumption and disease, and have been working on a number of other potential lawsuits with a public health impact.

We provided help to communities seeking to adopt and implement tobacco prevention policies, promoted smoke-free housing policies, and are working to disseminate the Tobacco-Free Generation approach to phase out tobacco sales entirely over time.

We created and curate a new web-based database of all of the tobacco prevention secondary literature that allows advocates to quickly find current resources and evidence on a range of tobacco prevention topics vital to policy making.

Most recently, we published a report on state policies to help get drinking water to children in schools and childcare centers.

PHAI administers the Violence Transformed project which uses a variety of trauma-informed approaches to utilize art creation and expression as a means to reduce the impact of violence in the community. We are currently collaborating with others on a project that is exploring the role that this approach might have in the context of housing insecurity in the Dorchester neighborhood of Boston.

We also continue to administer the Beyond OSHA project that works to improve the health and safety of some of the most vulnerable workers in the U.S..

In short, we continue to work our hardest to develop and implement “big ideas for advancing public health and social justice.”  We are not afraid to take on the big corporations that profit at a tremendous cost to public health and develop new approaches to make a healthier world.

We do this without the benefit of any huge grants or contracts or gifts.  While some of our income derives from fee for service work, much of our work is funded only through donations to PHAI from individuals who are passionate about public health.


Or mail your check to:
The Public Health Advocacy Institute, Inc.
360 Huntington Avenue #117CU
Boston MA 02115-5000

or contact us for more information at 617.373.2026 or moreinfo@phaionline.org.

FDA Reboots Tobacco Regulation with Harm Reduction

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
Reprinted from: