Hawaii Breathes New Life into Tobacco Debate

State becomes the first to raise its legal smoking age to 21. Will more follow suit?


Kristina Peters, Assistant Managing Editor, CSP – September 2015

Hawaii captured headlines June 19 after Gov. David Ige signed legislation making the nation’s 50th state the first to prohibit the sale, purchase, possession or consumption of tobacco products (including electronic cigarettes) for anyone younger than 21 years old.

The measure—effective Jan. 1—could potentially have a domino effect as several other states look to pass similar bills. Contenders include Massachusetts, New Jersey, New York and California, which all have pending 21-and-older tobacco legislation. (Similar measures have failed in several states, including Rhode Island, Oregon and Utah. For more on local regulations, see p. 134.)

But first, lawmakers must consider the potential consequences of raising the legal age to buy and use tobacco products and whether such action would increase or decrease underage use.

Ongoing Debate

Experimentation with tobacco almost always begins at a young age: Among adults who have ever smoked cigarettes daily, 86.9% tried their first cigarette by age 18 and an additional 11.5% tried their first cigarette between ages 18 and 26, according to the 2014 Surgeon General report “The Health Consequences of Smoking—50 Years of Progress.”

This early exposure often leads to greater levels of nicotine dependency and continued smoking beyond adolescence, as further shown in the Surgeon General report: More than 64% of adult smokers began to smoke daily by age 18, and 22.7% began to smoke daily between ages 18 and 26.

It is for these reasons organizations such as the Campaign for Tobacco-Free Kids approve of raising the age of sale for tobacco products to 21. Vince Willmore, vice president of communications for the Campaign for Tobacco-Free Kids, Washington, D.C., says the agency “strongly supports” such measures and encourages other states and communities to adopt them.

Increasing the sale age, Willmore says, “will reduce tobacco use among youth and young adults—age groups … that are heavily targeted by the tobacco industry.”

But NATO executive director Thomas Briant cautions that raising the legal age “may cause some underage youth to seek out tobacco products for the very reason that they are not allowed to buy and use them. … This could lead to youth relying more heavily on social sources of tobacco products (friends, family members, strangers) and undermine the goal of reducing tobacco use by youth.”

According to a study released by the Journal of School Health in August 2014, 86% of underage youth obtain cigarettes from these social sources.

But the Institute of Medicine says a higher tobacco age limit will likely mean a smaller network of legal-age smokers for nonsmoking youth to obtain tobacco products from. If all states were to raise the minimum age to 21, the institute says, there would be a 12% decrease in cigarette-smoking prevalence across the nation by 2100.

Alcohol Parallel

Raising the legal-age limit of tobacco to 21 draws a comparison to the legal-age limit of alcohol.

According to the National Youth Tobacco Survey and the Youth Risk Behavior Study—both conducted by the U.S. Centers for Disease Control (CDC)—alcohol use is more prevalent among teenagers than cigarette use, despite its legal-age limit of 21 in the United States.

The studies found smoking among high school students was at 9.2% in 2014 (down from 15.8% in 2011), while drinking alcohol was at 34.9%.

“A conclusion can be drawn that mandating an age of 21 for the purchase and consumption of alcohol has not created an impediment for more than one-third of minors who are currently consuming alcohol,” Briant wrote in a recent Tobacco E­News story. “This … raises the more serious health-related question of whether such a change of purchase could actually result in an increase in underage tobacco use.”

More States to Follow?

But the issue is just as much of a matter of personal rights, with the argument being that Americans are given other responsibilities at age 18.

“Personal rights are important because government and society impose responsibilities and duties on those who have reached the age of 18, and the magnitude of those obligations should also allow a person of adult age to choose what legal products they desire to purchase,” Briant wrote.

Some of these responsibilities include voting, military service, marriage, divorce, candidacy for public office and prosecution as an adult for crimes committed.

However, personal rights aside, it seems most Americans approve of a 21-and-older tobacco age limit.

Three out of four American adults—including seven in 10 cigarette smokers—favor raising the minimum age of sale for all tobacco products to 21, according to an article by the CDC. While an overwhelming majority of adults favored the policy overall, favorability is slightly higher among older adults and adults who never smoked. In contrast, 11% of adults strongly opposed making 21 the legal age of sale, while 14% somewhat opposed such measures.

If more states were to follow Hawaii’s lead, it could come at a cost for retailers no longer able to sell tobacco products to anyone age 18, 19 or 20, depending upon the state’s previous age limit. (Alabama, Alaska, Utah and New Jersey all have tobacco age limits of 19.) Until then, advocates, opponents and retailers alike will closely watch what happens in Hawaii after the new year.

Components of Hawaii’s Tobacco Law

Beginning Jan. 1, Hawaii will prohibit the sale, purchase, possession or consumption of tobacco products (including electronic cigarettes) for anyone younger than 21 years old. Here’s a look at other components of the law.

  • No grandfather clause: Eighteen- and 19-year-olds who can smoke legally now will not be able to next year.
  • Fines for retailers: Stores caught selling tobacco products to minors will be fıned $500 for the fırst offense and $500 to $2,000 for each violation after that.
  • Fines for minors: Anyone under age 21 caught using tobacco products will be fıned $10 for the fırst offense and $50 for subsequent offenses. Violators also may have to perform 48 to 72 hours of community service

22nd Century Group Makes Moves Around Modified Risk

New hire is experienced in FDA compliance approval.

CLARENCE, N.Y. — 22nd Century Group Inc. is growing its executive team to help navigate the company’s path through the Food and Drug Administration (FDA) modified-risk process.

Gregg M. Gellman joined the company as director of business development and regulatory affairs. He was hired for his experience in achieving FDA compliance approval for various types of products, according to the company.

Gellman will be tasked with driving 22nd Century’s regulatory affairs strategies for the company’s two modified-risk cigarettes in development: “BRAND A,” the world’s lowest nicotine tobacco cigarette, and “BRAND B,” the world’s lowest tar-to-nicotine ratio cigarette.

“Hiring Gregg Gellman represents another important step in 22nd Century’s mission to bring reduced-exposure cigarettes to American smokers,” said Henry Sicignano III, the company’s president and CEO. “Unlike some of our larger competitors, who market their products with implied health claims, 22nd Century is committed to working collaboratively with the FDA to demonstrate that our very low nicotine cigarettes and our low tar-to-nicotine ratio cigarettes are legitimate — and enormously important — modified-risk tobacco products.”

22nd Century hopes to become the first company authorized by the FDA to market reduced-exposure combustible cigarettes. It intends to submit its application for “BRAND A” to the agency this fall.

At the same time, because regulatory pre-approval is not required to label very low nicotine cigarettes outside of the United States, the company will expand distribution of its MAGIC 0 Very Low Nicotine cigarettes in Europe. As sufficient funds are secured for additional exposure studies, the company intends to submit an application to the FDA for “BRAND B” in 2016.

– See more at: http://www.csnews.com/product-categories/tobacco/22nd-century-group-makes-moves-around-modified-risk?cc=5#sthash.bKdjWjiL.dpuf

Are CVS’ Anti-Smoking Efforts Impacting Cigarette Purchases?

CVSResearch shows a decrease in cigarette smoking after CVS stops selling tobacco products.

In an attempt to decrease impulse cigarette purchases and to promote public health, one year ago, CVS decided to stop selling tobacco in its stores, nationwide. Despite the belief that this move would have little impact upon cigarette sales, a recent study has shown a change in the market since CVS stores made the change.

According to a report by the Daily Record, the study, which was conducted by CVS’ Health Research Institute, revealed that approximately 95 million fewer packs of cigarettes were sold in the eight months after CVS stopped selling tobacco products. That means that, individually, smokers purchased five fewer packs of cigarettes in those eight months, resulting in a 1% decrease in the total number of packs sold.

Additionally, the study revealed a 4% increase in nicotine patch purchases in the 13 states where CVS stores are located. It is believed that this data indicates an increase in attempts to quit smoking.

CVS is committed to its anti-smoking efforts, and the company recently announced that it will be funding a new tobacco-prevention curriculum through Scholastic.

Does New JAMA Pediatrics Study Show that E-Cigarettes are a Gateway to Youth Smoking?

An article published yesterday online in the Journal of the American Medical Association Internal Medicine (JAMA Internal Medicine) advises physicians to discourage their patients from trying to quit smoking using electronic cigarettes.

(See: McMillen RC, Gottlieb MA, Winickoff JP. E-Cigarettes — The roles of regulation and clinicians. JAMA Internal Medicine. Published online August 31, 2015. doi:10.1001/jamainternmed.2015.4436.)

Arguing that “e-cigarettes primarily emit a toxic aerosol,” and that “the use of e-cigarettes as well as conventional cigarettes may actually frustrate cessation attempts,” the article concludes that “counseling patients to use e-cigarettes is a practice that is currently not supported by evidence.” The article also argues that counseling patients to quit smoking using e-cigarettes “should be considered off-label advice.”

The article does acknowledge, however, that: “If research demonstrates health benefits to smokers who are able to completely switch from combustible tobacco products to e-cigarettes, these products could yet be approved for smoking cessation.”

The Rest of the Story

Unfortunately, this article has it all wrong. It misrepresents the current scientific evidence, ignores much of the evidence, misconstrues the paradigm for e-cigarette use, and thus ends up offering inappropriate and irresponsible advice to clinicians regarding the potential role of electronic cigarettes in smoking cessation.

To see just how bad this advice is, consider the following scenario:

A 56-year old smoker with a 40 pack-year history (1 pack per day since age 16) presents to his physician with a desire to quit smoking. He has tried nicotine replacement therapy and varenicline unsuccessfully in the past. He therefore has no interest in using FDA-approved smoking cessation drugs again. However, several of his close friends and family members have quit successfully using e-cigarettes, and he is intrigued by the possibility that this approach might work for him, since he feels the need to maintain the physical acts of smoking behavior rather than just slop nicotine onto his chest. What should the physician recommend?

According to the article, there is no evidence for the physician to recommend that the patient go ahead and try to quit using e-cigarettes and instead, the physician should recommend that the patient once again use nicotine replacement therapy, even though it failed multiple times in the past. The physician is instructed to discourage the quit attempt with electronic cigarettes, which would constitute “off-label” use that is not supported by evidence and which might actually “frustrate” this smoker’s cessation attempt.

Obviously, the most likely result of the physician’s advice is that the smoker will return home and continue to puff like a chimney, since he has no desire to once again use the nicotine patch, nicotine gum, or Chantix, which nearly drove him crazy the first time he tried it.

Clearly, this recommended advice is inappropriate and irresponsible. Given the smoker’s enthusiasm for trying e-cigarettes, he should be encouraged to give it a try, praised for his desire to quit, and wished the best of luck in his attempt. He should be advised to try to switch completely to e-cigarettes rather than become a dual user. However, if it comes to a choice between dual use or smoking only, he should be encouraged to use as many e-cigarettes as few real cigarettes as possible. Based on clinical data, the most likely outcome is that the smoker will either quit or greatly reduce the amount that he smokes, a much better outcome than what would have likely occurred had he been advised to try “FDA-approved” methods (which work about 10% of the time anyway).

The chances of the smoker quitting using e-cigarettes are at least as high as him quitting with NRT, but the chances of him at least greatly reducing his cigarette consumption are much higher. And, as the authors of the article acknowledge: “cutting back on smoking behavior is often more acceptable to smokers who resist quitting entirely and increases quit rates in the long term.” In fact, this is precisely why encouraging smokers who have failed to quit using NRT or drugs in the past is such appropriate advice.

In this article, the problem is not merely that irresponsible advice is given but that this advice is based on a misrepresentation of the scientific evidence.

First, calling e-cigarette aerosol “primarily a toxic aerosol” is misleading. Consider the case of VUSE. With the exception of propylene glycol and nicotine, the aerosol has been shown not to contain detectable amounts of any “toxic” chemicals. The same is true with Mark Ten, NJOY, and many other e-cigarette brands in the market. While it is true that some e-cigarette brands produce formaldehyde, these brands are still much, much safer than real cigarettes. Moreover, if the physician is concerned, she can simply recommend one of the brands whose testing has demonstrated that carcinogens such as tobacco-specific nitrosamines and formaldehyde are not a problem. Even recommending a brand that does produce some formaldehyde is warranted, but the benefits of the patient quitting smoking far outweigh the slight risk of exposure to a relatively small dose of formaldehyde. Rather than characterizing e-cigarette vapor as “primarily a toxic aerosol,” one could characterize it as “a relatively safe form of nicotine” (compared to cigarettes).

Second, it is simply not the case that the use of e-cigarettes “frustrates” quit attempts. There is absolutely no evidence to support this contention. Instead, the overwhelming body of evidence suggests that e-cigarettes are an effective smoking cessation aid, at least as effective as the current “FDA-approved” cessation methods.

Third, it is not true that counseling patients to quit using e-cigarettes is not supported by evidence. There is strong evidence that e-cigarettes have helped thousands of smokers quit and that these products have greatly improved the health of these vapers. There is solid evidence, for example, that asthmatic smokers who switch to e-cigarettes experience an immediate improvement in their respiratory symptoms as well as in their lung function.

Finally, advising patients to try e-cigarettes to quit smoking is not “off-label” advice. Why? Because there is no “on-label” advice. E-cigarettes are not drugs. They are properly viewed not as drugs, but as an alternative form of nicotine delivery that is much safer than smoking. This is a “recreational use” of the product, not an FDA-approved drug use. And it never will be an FDA-approved drug. These products will be regulated as nicotine-containing products, but not as drugs. (Note: They could be regulated as drugs if they make therapeutic claims, but no company is going to make such claims if it requires them to seek approval from the Center for Drug Evaluation and Research rather than from the Center for Tobacco Products.)

Interestingly, the paper acknowledges that “if” research shows health benefits to smokers who switch to e-cigarettes, then the products should then be recommended by physicians. But we already have that evidence! We know that switching to e-cigarettes conveys immediate health benefits to smokers. Ask any vaper! Or, simply look at the research.

I should note that I have no problem with most of the article’s recommendations regarding the regulation of e-cigarettes. I agree that these products need to be regulated by the FDA, that there needs to be restrictions on the sale and marketing of these products to youth, that there needs to be basic safety and quality control guidelines, and that children need to be protected from accidental ingestion of liquid nicotine.

However, it is unfortunate that the article feels the need to go further than recommending these regulations, and that it extends to providing irresponsible advice to physicians regarding smoking cessation.

This article as well as other “Rest of the Story” posts are found on the Tobacco Today blog roll.

Smokeless Tobacco Banned in Fenway

Dodger Stadium likely next in growing list of sports arenas banning OTP use

Published in CSP Daily News


Steve Holtz, Online News Director & Beverage Editor, CSP

BOSTON & LOS ANGELES – Don’t try enjoying a dip of smokeless tobacco at a Boston Red Sox home game next season, whether a player or spectator, unless you’re prepared to pay a hefty fine. The city has banned smokeless tobacco use in the ballpark beginning April 1, 2016, and Los Angeles is well on the way to doing the same.

Boston joined San Francisco this week in banning smokeless tobacco products in athletic facilities when Mayor Marty Walsh signed an ordinance Wednesday prohibiting the use of tobacco and other tobacco products at baseball parks, from Fenway Park to smaller sports venues.

The ordinance defines smokeless tobacco as any product that contains cut, ground, powdered or leaf tobacco meant to be put in your mouth or nose, according to a Boston Globe report. That means no snuff, chewing tobacco, dipping tobacco, dissolvable tobacco products or snus.

Violators face a $250 fine.

Los Angeles City Council members, meanwhile, took a strong first step Tuesday toward striking smokeless tobacco out of all sports venues in the city.

A motion to ban the use of chewing tobacco and snuff, introduced in June by Councilman Jose Huizar, passed 14-0. It called for the city attorney to draft an ordinance to cover all venues within the city where any organized sport, amateur or professional, is played, including Dodger Stadium.

The council will take a final vote on the measure once the city attorney’s office has prepared the ordinance, which the lawmakers asked for within 30 days. The measure would apply to players, fans and anyone in a sports venue.

It’s expected to be implemented by January, according to a report in the Los Angeles Times.

“Today, the city of Los Angeles joins the ranks of San Francisco and Boston in what is becoming a national effort to knock tobacco out of the park,” Huizar said in a statement. “Smokeless tobacco use in the great American pastime is way past its time. The time to act is now to save others, particularly our young people, from an extremely addictive and potentially deadly product.”

The city already has in place similar bans on smoking and e-cigarettes.

Earlier this year, San Francisco Mayor Ed Lee signed an ordinance eliminating smokeless tobacco at the city’s athletic fields, making it the first city in the nation to enact such a restriction.

Public Health England: E-Cigs 95% Less Harmful Than Tobacco

Review finds most British smokers using electronic cigarettes to quit, not start again

Published in CSP Daily News

E-cigarettes vaping

LONDON – Electronic cigarettes are significantly less harmful to health than tobacco and have the potential to help smokers quit smoking, an independent review published by governmental agency Public Health England (PHE) has concluded.

Key findings of the review include:

  • The current best estimate is that e-cigarettes are around 95% less harmful than smoking.
  • Nearly half the population (44.8%) doesn’t realize e-cigarettes are much less harmful than smoking.
  • There is no evidence so far that e-cigarettes are acting as a route into smoking for children or non-smokers.

The review, commissioned by PHE and led by Professor Ann McNeill, King’s College London, and Professor Peter Hajek, Queen Mary University of London, suggests that e-cigarettes may be contributing to falling smoking rates among adults and young people. Following the review PHE has published a paper on the implications of the evidence for policy and practice.

The comprehensive review of the evidence finds that almost all of the 2.6 million adults using e-cigarettes in Great Britain are current or ex-smokers, most of whom are using the devices to help them quit smoking or to prevent them going back to cigarettes. It also provides reassurance that very few adults and young people who have never smoked are becoming regular e-cigarette users (less than 1% in each group).

The review raises concerns, however, that increasing numbers of people think e-cigarettes are equally or more harmful than smoking (22.1% in 2015, up from 8.1% in 2013: ASH Smokefree GB survey) or don’t know (22.7% in 2015, ASH Smokefree GB survey).

Despite this trend all current evidence finds that e-cigarettes carry a fraction of the risk of smoking.

Emerging evidence suggests smokers who use e-cigarettes and also receive additional support from their local stop-smoking services are among those with the highest successful quit rates, PHE said.

E-cigarettes are not completely risk free, said PHE, but when compared to smoking, evidence shows they carry just a fraction of the harm. The problem is people increasingly think they are at least as harmful and this may be keeping millions of smokers from quitting, it said.

“Local stop-smoking services should look to support e-cigarette users in their journey to quitting completely,” the agency said.

“There is no evidence that e-cigarettes are undermining England’s falling smoking rates,” said McNeill. “Instead, the evidence consistently finds that e-cigarettes are another tool for stopping smoking, and in my view, smokers should try vaping and vapers should stop smoking entirely.”

PHE said “e-cigarettes could be a game changer in public health in particular by reducing the enormous health inequalities caused by smoking.”

“My reading of the evidence is that smokers who switch to vaping remove almost all the risks smoking poses to their health. Smokers differ in their needs and I would advise them not to give up on e-cigarettes if they do not like the first one they try. It may take some experimentation with different products and e-liquids to find the right one,” sad Hajek.

Professor Linda Bauld, Cancer Research UK’s expert in cancer prevention, said, “Fears that e-cigarettes have made smoking seem normal again or even led to people taking up tobacco smoking are not so far being realized based on the evidence assessed by this important independent review. In fact, the overall evidence points to e-cigarettes actually helping people to give up smoking tobacco.”

Click here to view the full reports.


FDA director Mitch Zeller to speak

Published in Tobacco E-News


Thomas A. Briant, NATO Executive Director
FDA Director Mitch Zeller

MINNEAPOLIS — One of the most important reasons for tobacco retailers and wholesalers to attend the 2016 NATO Show and for manufacturers and suppliers to exhibit at the 2016 NATO Show is the fact that the net revenue from the trade show is used by NATO to support and fund the association’s efforts to respond to local, state, and federal tobacco-related legislation.

With NATO being the only national retail association that opposes tobacco legislation on every kind of tobacco product at every level of government, the success of the NATO Show directly translates into supporting NATO’s legislative efforts. Attending and exhibiting at the NATO Show is significant because doing so results in a successful trade show which, in turn, helps NATO pursue its mission to respond to tobacco legislation.

The 2016 NATO Show will be held on April 19-21, 2016, at the Paris Hotel in Las Vegas. Just like the 2015 NATO Show, the upcoming 2016 NATO Show will have an excellent lineup of educational seminars. As a followup to his presentation at the 2015 NATO Show, FDA Director Mitch Zeller has accepted an invitation to speak at the 2016 NATO Show on current FDA tobacco regulations. If you want to know about the latest in FDA tobacco regulations, then it is very important to plan to attend the 2016 NATO Show.

In addition, other seminar topics include tobacco product marketplace trends and insights, maximizing e-vapor sales and profits, marketing strategies for retailers to gain the competitive advantage, and concurrent sessions on premium cigars and domestic cigars.

The premium cigar seminar will complement the new Premium Cigar Pavilion at the 2016 NATO Show, which will showcase the premium cigar segment and offer a cigar lounge for attendees to socialize and network.

To learn more about the 2016 NATO Show, you can visit www.NATOShow.com.  In addition, prospective exhibitors can contact ConvExx, the NATO Show management company, about renting a booth and sponsorship opportunities.  ConvExx has decades of experience in managing trade shows held in Las Vegas and the main ConvExx contact person for the NATO Show is Jennifer Carr at 702-216-5852 or jcarr@convexx.com.

Since the NATO Show exists to support NATO’s legislative mission, mark your calendars now to attend the 2016 NATO Show in Las Vegas.

Tobacco Companies in Canada Ordered To Pay $15 Billion To Smokers

cigarettesMore than 1 million smokers win a lawsuit against three tobacco companies.

In Canada, three tobacco companies— Imperial Tobacco, Rothmans Benson & Hedges and JTI-MacDonald—have been ordered to pay $15 billion in damages after losing a historic court case, according to CBC News Montreal. All three tobacco companies issued statements saying they plan to appeal the ruling.

Judge Brian Riordan on Monday ruled in favor of two groups representing Quebec smokers. The court case began in March 2012, some 13 years after two class-action lawsuits were first sought by groups made up of about 1 million people.

  • One of the lawsuits, “the Blais File,” was put forth by people who said they became seriously ill from smoking.
  • The second lawsuit, “the Létourneau File,” was filed by a group of people who claim they are unable to quit smoking.

As reported by CBC Montreal, both groups alleged the three tobacco companies in the lawsuit:

  • Failed to properly warn their customers about the dangers of smoking.
  • Underestimated evidence relating to the harmful effects of tobacco.
  • Engaged in unscrupulous marketing.
  • Destroyed documents.

The plaintiffs with cancer are set to receive various amounts of money based on their illness and time spent smoking. For example, those with cancer who began smoking before January 1976 will receive $100,000 each, while those started smoking after January 1976 will receive $90,000.

The plaintiffs battling emphysema will receive $30,000 in moral damages if they began smoking before Jan. 1, 1976, and $24,000 if they started smoking after that date.

The almost one million Quebec smokers who were unable to quit will each receive about $130 per person.

Tobacco Companies to Appeal
JTI-Macdonald Corp. issued a statement minutes after the ruling, saying it plans to appeal the judgment. “The company strongly believes that the evidence presented at trial does not justify the court’s conclusions,” the statement said. “Since the 1950s, Canadians have had a very high awareness of the health risks of smoking. That awareness has been reinforced by the health warnings printed on every legal cigarette package for more than 40 years.”

Imperial Tobacco Canada and Rothmans Benson & Hedges also announced they plan to appeal the ruling.

Despite plans to appeal, the ruling says that at least $1 billion in damages must be paid: “The Court orders the provisional execution of the judgment notwithstanding appeal with respect to the initial deposit of one billion dollars of moral damages, plus all punitive damages awarded.”