Emerging Tobacco Products
A number of new tobacco products have been introduced into the North American Marketplace in the past few years. These include products such as Electronic Cigarettes (e-cigarettes), SNUS, dissolvable tobacco products (DTPs), and tobacco sticks. To respond to the many new products entering today’s marketplace, NTCC will be hosting a webinar on emerging products on 7/12 from 1-2pm EDT. To participate in the webinar, please send an email to BJ McDuffie at firstname.lastname@example.org by Friday July 8, 2011.
An example of the reach e-cigarette companies are seeking to gain in the marketplace was found in a press release from Rapid Fire Marketing (RFMK) on June 22, 2011. This release announced that the e-cigarette brand “Bionic Cigs” would be a featured sponsor at the upcoming NASCAR Brickyard 400 race, one of NASCAR’s most popular events. This deal would include 288 advertising spots for the brand over the course of the event, which is popular among families with children, and young adults. This may strengthen the appeal of a brand and a product that up until the event may have had little recognition among this population.
SNUS, a product originally produced in Sweden, is a type of moistened, finely ground tobacco. Each container of SNUS contains several individually packs of SNUS, which are single doses of tobacco in a porous, teabag-like pouch. Users then place a pouch between the lower lip and bottom teeth, where nicotine is then absorbed through the lip membrane. In a factsheet on smokeless tobacco products, Legacy wrote that part of the appeal of SNUS is that unlike other oral tobacco products, such as chewing tobacco, SNUS does not result in excess saliva production and thus does not require users to spit. This also makes it harder to detect whether someone is using SNUS.
Popular brands of SNUS include Camel, Marlboro and Triumph, with flavors ranging from peppermint, spearmint, ‘mellow’, and ‘robust’. Packaging is sleek and can resemble gum or mint boxes. This can be appealing for youth that may not enjoy the strong flavor of plain tobacco, but who may be enticed by something mint-flavored and sleek looking.
Health risks associated with SNUS are similar to those of chewing tobacco products:
Users typically find SNUS more appealing because it is a less harsh version of chewing tobacco—it does not burn the cheek and mouth as much as chewing tobacco does. Also favorable is the fact that users do not need to spit. Therefore, SNUS can be used anywhere, even in places where smoking is prohibited. There is a risk for people to use SNUS while also smoking cigarettes, which can make it more difficult to end a nicotine addiction.
Dissolvable Tobacco Products (DTPs) and Tobacco Sticks
DTPs strongly resemble candy in appearance, flavor, and packaging. They are sold in flavors such as mint, chocolate, and coffee, and may be difficult for people to distinguish between non-tobacco products, such as mints and gum. Several health organizations including The American Heart Association, the American Lung Association, The Cancer Action Network and The American Legacy Foundation, wrote a letter to the FDA expressing their concerns for DTPs. The letter outlines several reasons why DTPs are potentially harmful for consumers including:
DTPs and tobacco sticks and strips appeal to youth because there is no spitting or leftovers that could alert adults to their use; the products burn the mouth less than other products; and they are also highly flavored and resemble candy. Popular brands include Camel Orbs, Camel Strips and Sticks, Ariva, and Stonewall.
A number of health organizations and smoking cessation groups are speaking out against this new breed of tobacco products. These include those mentioned earlier in the FDA letter, and others such as the Campaign for Tobacco Free Kids, and the Truth campaign. In their letter to the FDA, these groups urge that the “FDA ensure that none of the dissolvable products be marketed with any explicit or implicit claims that they reduce the risk or are safer than any other tobacco product.” This is to prevent tobacco companies from misleading people into abusing a product that may substitute the vessel of their nicotine addiction from one product, cigarettes for example, to another such as e-cigarettes or DTPs.
Since according to a fact sheet by the Kansas Department of Health and Environment (KDHE), “dissolvable tobacco products may contain up to three times the amount of nicotine absorbed by a smoker from one cigarette,” these products can be extremely addictive and potentially toxic to consumers. This is especially harmful to those who continue to smoke while using a smokeless tobacco product, and to children who may find an unguarded DTP and consume a lethal amount of nicotine, thinking it was candy.
The Next Generation of Products
In the near future there also appears to be a new generation of tobacco products under development, including a new technology that would deliver nicotine via an aerosol burst. In a May 26, 2011 AP article, Michael Felberbaum reported that Jed Rose, the Director of the Center for Nicotine and Smoking Cessation Research at Duke University, has sold this new aerosol technology to Phillip Morris International (PMI).
Developers of this technology are excited by this product because of its ability to avoid "the burning process altogether, finding a way of giving smokers nicotine to inhale but without those toxic substances," Rose said. He hopes that this technology will pave the way for future products that will potentially reduce the occurrence of smoking-related diseases, and death from cigarette fumes.
What this product does not directly address so far is the issue of nicotine addiction or abuse among users. It will be worth watching how the aerosol spray develops and to see how PMI markets the aerosol spray to the public.
In the marketplace today there is a proliferation of smokeless tobacco products, with new technologies being continuously developed. While the health benefits purported by manufacturers of smokeless tobacco are less impressive than the reported dangers to consumers, the appeal of these products to consumers is only increasing with marketing advances by producers.
The quit-smoking drug Chantix may lead to a small but increased risk of heart problems in people with cardiovascular disease, the U.S. Food and Drug Administration said.
In a study of 700 smokers with cardiovascular disease who were undergoing treatment with Chantix or a placebo, researchers saw a small but "statistically significant" greater risk of chest pain, non-fatal heart attacks and other cardiovascular problems in patients taking the quit-smoking drug, the FDA said. Details of the new findings will be shared with doctors and will be included in the drug's medication guide to patients, the agency said.
In July 2009, the FDA mandated that Chantix (varenicline tartrate) and a second smoking-cessation drug, Zyban, carry a "black-box" warning about the potential risks of psychiatric problems, including depression and suicidal thoughts.
In its announcement Thursday, the FDA noted that smoking is a major contributor to cardiovascular disease, the number one killer of Americans. So doctors and their patients should weigh the "known benefits of Chantix against its potential risks when deciding to use the drug in smokers with cardiovascular disease," the agency said in a statement on its website.
Patients taking Chantix, which received FDA approval in 2006, should contact their health-care professional if they experience new or worsening symptoms of cardiovascular disease.
The FDA said it will continue to evaluate the risks and benefits associated with Chantix and is requiring the manufacturer -- Pfizer Inc. -- to conduct an analysis of all previous randomized, placebo-controlled trials of the drug. The agency said it will release those findings to the public when they become available. In a statement, Pfizer pointed out that smoking is a key risk factor for heart disease, and quitting the habit brings heart benefits that are "immediate and substantial," the Wall Street Journal reported. Pfizer agreed that patients should talk to their doctors to "determine what medications are right for them."
The risk of recurrence of the disease was similarly high for smokers, said the researchers, who analysed medical data of 5,300 men diagnosed with the disease between 1986 and 2006.
Men who smoked were also found to have more aggressive tumours at the time of their diagnosis. Among patients whose disease had not spread when first detected, smokers were 80% more likely than non-smokers to die.
Findings from the study - the largest of its kind to explore the link between smoking and prostate cancer - are published in the Journal of the American Medical Association.
Study leader, Dr Stacey Kenfield, said: "We found similar results for both prostate cancer recurrence and prostate cancer mortality. These data taken together provide further support that smoking may increase risk of prostate cancer progression."
The researchers also found that the death rates among prostate cancer patients who had quit smoking for more than 10 years were similar to that for non-smokers.
The same was true for men who had quit for less than 10 years, but were previously only moderate smokers.
"These data are exciting because there are few known ways for a man to reduce his risk of dying from prostate cancer," said Professor Edward Giovannucci, another member of the Harvard team.
"For smokers, quitting can impact their risk of dying from prostate cancer. This is another reason not to smoke.”
Tobacco companies increased the advertising and lowered the sale price of menthol cigarettes in stores near California high schools with larger populations of African-American students, according to a new study from the Stanford University School of Medicine.
Although cigarette makers have denied using race or ethnicity to target customers, the lead researcher for the study said the data shows a "predatory" marketing pattern geared to luring young African Americans into becoming smokers.
"The tobacco companies went out of their way to argue to the Food & Drug Administration that they don't use racial targeting," said Lisa Henriksen, PhD, senior research scientist at the Stanford Prevention Research Center. "This evidence is not consistent with those claims."
Henriksen is the first author of this study, which was published online June 24 in Nicotine & Tobacco Research.
The study comes at a time when the FDA is gathering information on whether to ban menthol as a flavoring agent in cigarettes. A federal law passed in 2008 banned 13 candy flavorings in cigarettes but allowed for the continued use of menthol. Menthol makes the smoke from tobacco smoother and less harsh; even non- menthol cigarettes often have low levels of the substance.
A draft report by the Tobacco Products Scientific Advisory Committee, which the FDA asked to investigate the harms from the use and marketing of menthol cigarettes, found that the use of menthol cigarettes is highest among minorities, teenagers and low-income populations. Advertisements often tout the "freshness" of menthol cigarettes, and the report said many smokers mistakenly believe that the addition of menthol makes cigarettes less of a health risk.
The committee's report says that "removal of menthol cigarettes from the marketplace would benefit public health in the United States," but the FDA doesn't have to follow the group's recommendation.
The committee is scheduled to meet July 21 in Rockville, Md., to discuss final changes to the document. An FDA spokesman said the edited version of the report will be posted soon on the agency's website, but there is no timeline yet as to when the FDA will make a decision on menthol. "The committee was charged with considering a broad definition of harm to smokers and other populations, particularly youth," said Henriksen. "We think our study, which shows the predatory marketing in school neighborhoods with higher concentrations of youth and African-American students, fits a broad definition of harm."
In the Stanford study, Henriksen and her colleagues note that the preference for menthol cigarettes among teenage smokers increased from 43.4 percent in 2004 to 48.3 percent in 2008. Menthol cigarettes were also most popular among African-American smokers ages 12-17 (71.9 percent), compared to Hispanics (47 percent) and non-Hispanic whites (41 percent) of the same ages.
To find out how the leading brands of menthol and non-menthol cigarettes were promoted near California high schools, the researchers randomly selected convenience stores, small markets and other tobacco retailers within easy walking distance of 91 schools. The researchers then rated how the cigarettes were marketed in those stores. The data were collected in 2006.
The researchers found that for every 10-percentage-point increase in the proportion of African-American students at a school, the proportion of advertisements for menthol cigarettes increased by 5.9 percentage points. Additionally, the odds of an advertised discount for Newport, the leading brand of menthol cigarettes, were 1.5 times greater.
When it came to price, the average per-pack price for Newport was $4.37 at the time of the study, with Marlboro - the leading non-menthol brand - averaging $3.99. It also found that for every 10-percentage-point increase in the proportion of African-American students at the nearby school, the per-pack price for Newport was 12 cents lower. Advertised discounts and prices for Marlboro, however, were unrelated to school or neighborhood demographics.
"That's important because lower prices tend to lead to increased cigarette use," Henriksen said.
In addition, the study found that for each 10-percentage-point increase in the proportion of neighborhood residents ages 10-17, the proportion of menthol advertisements increased by 11.6 percentage points, and the odds of an advertised discount for Newport was 5.3 times greater.
Although the study was limited to California high schools, the authors believe the findings would be similar throughout the country.
"When kids are exposed to more cigarette advertising they are more likely to start smoking, which will undoubtedly lead to dire health consequences," said senior author Stephen Fortmann, MD, a professor emeritus of medicine at Stanford who is now a senior investigator at Kaiser Permanente Center for Health Research in Portland, Ore. "Our study finds that tobacco companies are trying to make smoking more attractive to teens, when we as a society should be doing just the opposite."
Given previous research that young smokers and African-American smokers are more sensitive to prices than other groups, Fortmann and Henriksen said they believe this study clearly shows how tobacco companies are trying to target black teens in marketing menthol cigarettes.
"Adding menthol to cigarettes makes it easier to smoke and harder to quit, so the public health community strongly supports an FDA ban on menthol flavoring," Fortmann said.
Other co-authors include statistical analyst Nina Schleicher, PhD, and project manager Amanda Dauphinee.
The study was funded by the California Tobacco-Related Disease Research Program, which was created after state residents voted in 1998 to impose a 25-cent per-pack surtax on cigarettes to reduce the human and economic costs of tobacco use.
More and more countries are banning the words "light" and "mild" from cigarette packs, but a new study suggests that may not be enough to dispel smokers' misbeliefs that the products are safer.
Researchers found that after the UK, Australia and Canada banned the terms as deceptive, there was a dip in the number of people who mistakenly believed that cigarettes marketed as "light" or "mild" carried fewer health risks.
However, the decline was temporary, the investigators report in the journal Addiction.
And in the UK, misperceptions were consistently higher versus the other two countries, as well as the U.S. -- where, at the time of the study, no such ban was in place.
"The findings from this study confirm our earlier work showing that merely removing the terms 'light' and 'mild' from cigarette packs is insufficient to change people's beliefs that those products are safer," lead researcher Dr. Hua-Hie Yong said in an email.
To really clear up misperceptions, more steps are needed, according to Yong, of the Cancer Council Victoria in Melbourne, Australia.
"Light" cigarettes are designated as such because they deliver less nicotine and lower levels of toxic chemicals -- or "tar" -- when the smoke is measured by a machine.
In real life, though, studies show that smokers inhale comparable amounts of nicotine and chemicals regardless of the brand. And critics have long charged that tobacco products dubbed "light" or "mild" confuse people into thinking there are fewer health risks.
In response, the European Union and Brazil put bans on those terms in 2003, and other countries have since followed suit.
A U.S. law that bars the words "light," "low tar" and "mild" from tobacco products went into effect almost exactly one year ago.
For the new study, Yong's team looked at results from an international survey done annually between 2002 and 2009 in Australia, Canada, the UK and the U.S.
The surveys involved a total of 21,600 smokers who were asked the extent to which they agreed with statements like, "Light cigarettes are less harmful than regular cigarettes."
Overall, the study found that shortly after "light" bans went into effect, misperceptions about the cigarettes generally dipped in Australia, Canada and the UK.
However, the false beliefs began to creep back in within a couple years. In the UK, which banned the terms in 2003, misperceptions remained persistently higher than in other countries, including the U.S. On average, UK smokers had a higher level of agreement with statements extolling the advantages of light cigarettes over regulars.
It's not clear why that is, according to Yong. But one reason, the researchers speculate, could be a UK law of the same time period that forced tobacco makers to lower the tar "yield" in cigarettes. That, Yong said, might have drawn smokers' attention to the tar issue, and reinforced the belief that lower tar means a safer cigarette.
After the U.S. ban went into effect last year, some health advocates, including the American Lung Association (ALA), applauded the move but said that deceptive packaging remains a problem.
Some manufacturers sell light and regular cigarettes in packages of different colors. And allowable terms like "smooth" and "silver," critics say, may still mislead consumers.
The current findings underscore the fact that no single step is enough to combat years of misleading tobacco marketing, according to Erika Sward, director of national policy and advocacy at the ALA.
"This is one more piece of information that points to a need for a big-picture, comprehensive solution," Sward said in an interview.
One change that could help, according to Sward, would be an end to the "color-coding" of cigarette packs that lets smokers know which ones are "light" or regular.
She said the ALA hopes that the Food and Drug Administration -- only recently given the power to regulate tobacco products -- will conduct research to see whether package coloring affects consumers' choices.
Australia recently introduced legislation to become the first country in the world to require all tobacco products to be sold in "plain packaging." The tobacco industry has come out against such a move, saying there's no evidence it would make a dent in smoking rates.
Both Yong and Sward pointed to a need for ongoing public education. Many smokers, Yong said, "continue to believe that some cigarettes are safer than others based on the fact that they taste 'milder' or it has a lower tar yield, and this false belief will keep them smoking instead of quitting."
"There is no safe cigarette on the market," Sward said. And if smokers want to do something for their health, she added, they can seek help in quitting -- from their doctors, the ALA, or the government-sponsored quitline 1-800-QUIT-NOW.
Tobacco sales to minors fell to an all-time low in 2010 after increasing in 2009, a new report shows.
Retailers in the USA sold tobacco to minors 9.3% of the time, the report by the Substance Abuse and Mental Health Services Administration (SAMHSA) shows. The statistics are gathered as part of the Synar Amendment program, a federal-state partnership to curb tobacco sales to minors. The 2010 rate of 9.3% is the lowest in the program's 14-year history.
"It's really good to see the rate go down, especially after it went up last year," says Danny McGoldrick, vice president of research at the Campaign for Tobacco-Free Kids.
In addition, 34 states had violation rates of less than 10% in 2010, up from 22 states in 2009.
Violations increased in 14 states, despite the national downward trend. Idaho, Maryland and New Hampshire, states with some of the highest rates of violations, saw rates increase from 2009.
The record low follows an uptick in tobacco sales to minors that occurred in 2009, where 10.9% of retailers had violations. The increase was the first in the program's history. It was also the highest rate since 2005.
Susan Marsiglia Gray, Synar coordinator for SAMHSA, says a tough economy led some states to make cuts to underage tobacco enforcement programs, which may have helped lead to the increase in underage sales.
Gray attributed a return to sales decreases in 2010 in part to the Family Smoking Prevention and Tobacco Control Act, signed by President Obama in 2009. Under the act, the FDA helps states conduct compliance checks of retailers. Gray also says some smaller outlets, which may have been more likely to sell to minors, have gone out of business.
The statistics are gathered through random, unannounced inspections of retail outlets. Under the Synar program, states must have a violation rate of 20% or less to be in compliance. The year 2010 marked the fifth year all states have been in compliance.
Though states have been in compliance for several years, efforts to decrease actual tobacco consumption by minors has stalled, Gray says. Minors may not be able to buy tobacco from retailers, but older siblings and friends still can. While taking away minors' retail access to tobacco is an important part in lowering consumption, it's not the only thing needed.
"States really need to take a comprehensive approach in reducing youth tobacco use," Gray says.
States with a low rate of violations tend to attack the issue at several levels, including merchant education and community pressure. Parents also play an important role. "We know one of the best ways to affect kids is to affect adults," McGoldrick says.
Smoking, Even for a Short Time, Significantly Increases a Woman’s Risk for Peripheral Artery Disease
A prospective study of initially healthy women aged 45 and over found that smoking is a potent risk factor for symptomatic peripheral artery disease, or PAD. PAD is a serious, often debilitating disorder, caused by narrowing of the arteries in the lower extremities. Symptoms of PAD include pain in the legs with normal activity and a feeling of tiredness in the leg muscles.
Researchers followed 38,825 women for an average of 12.7 years to determine if smoking increased a woman’s risk for PAD and if smoking cessation reduced that risk. The women were questioned about their smoking history and if they currently smoked cigarettes. If so, they were asked to disclose how many they smoked per day. During the course of the study, patients periodically filled out questionnaires about their health and smoking habits. Surveys were given twice during the first year and then once per year for the remainder of the study and follow-up period. Participants were asked to report any symptoms of PAD.
The researchers found that smoking increased a woman’s risk for PAD 10-fold. Smoking cessation reduced the risk, but even after abstaining from cigarettes for 20 years, the risk did not lower to that of a woman who had never smoked.
“This study showed that—as has been previously shown for heart attacks and for lung cancer—that smoking is actually very harmful for the development PAD,” said Eruna Pradhan, Assistant Professor of Medicine at Harvard Medical School and an author of the study. “This is significant because PAD is a disease that not only causes a lot of pain and discomfort with usual, daily activities but it also increases the risk of heart attack.”
Dead bodies, diseased lungs and a man on a ventilator were among the graphic images for revamped tobacco labels unveiled on Tuesday by U.S. health officials.
Proposed in November under a law that put the multibillion-dollar tobacco industry under the control of the Food and Drug Administration, the new labels must be on cigarette packages and in advertisements starting in October 2012.
Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg were to announce the nine new warnings at the White House, but the labels were released early Tuesday.
They show images that may disturb some, including one titled "WARNING: Cigarettes are addictive," illustrated with a photograph of a man smoking a cigarette through a hole in his throat. Among the images to appear on cigarette packs are rotting and diseased teeth and gums, the corpse of a smoker, diseased lungs, and a mother holding her baby with smoke swirling around them. They include phrases like "Smoking can kill you" and "Cigarettes cause cancer" and feature graphic images to convey the dangers of tobacco, which is responsible for about 443,000 deaths in the U.S. a year.
Other messages point out the dangers of secondhand smoke to children, tobacco's causal link to fatal lung disease, cancer, strokes, heart disease and death.
Sebelius said their goal is to stop children from starting to smoke and offer adults who want to quit some help.
"We have about 4,000 people under 18 who try their first cigarette and about 1,000 of them become permanent smokers. And that's not good for our country," she told the CBS "Early Show."
"This is really aimed at making sure kids don't start in the first place."
The 2009 Family Smoking Prevention and Tobacco Control Act called for cigarette packages to include warning statements in large type covering half of the front and back of each package and graphic images showing adverse health effects from smoking.
The warnings are also to occupy the top 20 percent of every tobacco advertisement of companies such as Altria Group Inc's Philip Morris unit, Reynolds American Inc's R.J. Reynolds Tobacco unit and Lorillard Inc's Lorillard Tobacco Co.
The anti-smoking group Campaign for Tobacco Free-Kids said the images represent a dramatic change from current health warnings.
"The current warnings are more than 25 years old, go unnoticed on the side of cigarette packs and fail to effectively communicate the serious health risks of smoking," the group said.
R.J. Reynolds has challenged the legality of mandated larger and graphic warnings in a federal lawsuit.
Why aren't more quitting?
The new labels come as the share of Americans who smoke has fallen dramatically since 1970, from nearly 40 percent to about 20 percent. The rate has stalled since about 2004. About 46 million adults in the U.S. smoke cigarettes.
It's unclear why declines in smoking have stalled. Some experts have cited tobacco company discount coupons on cigarettes or lack of funding for programs to discourage smoking or to help smokers quit.
While it is impossible to say how many people quit because of the labels, various studies suggest the labels do spur people to quit. The new labels offer the opportunity for a pack-a-day smoker to see graphic warnings on the dangers of cigarettes more than 7,000 times per year.
The FDA estimates the new labels will reduce the number of smokers by 213,000 in 2013, with smaller additional reductions through 2031.
Tobacco use costs the U.S. economy nearly $200 billion annually in medical costs and lost productivity, the FDA said. Tobacco companies spend about $12.5 billion annually on cigarette advertising and promotion, according to the latest data from the Federal Trade Commission.
The World Health Organization said in a survey done in countries with graphic warning labels that a majority of smokers noticed the warnings and more than 25 percent said the warnings led them to consider quitting.
A 1964 surgeon general's report that linked smoking to lung cancer and other diseases spurred a broad anti-smoking campaign and health warnings on cigarette packages.
Quitting smoking is only a click away for service members and dependants thanks to TRICARE’s new online counseling service.
All TRICARE members are eligible to receive tobacco cessation support through the Department of Defense website, www.ucanquit2.org. It’s a free online support system that prepares tobacco users to quit the habit, using interactive components such as quit tools, self-assessment questionnaires, quizzes and activities.
“It’s a new initiative TRICARE is adding to its services so people have an easier time getting tobacco cessation,” said Nicole Preston, Marine Corps Community Services Health Promotion director. “Its goal is easier access to care.”
Preston holds tobacco cessations classes through MCCS but encourages everyone to quit by using whatever method works best for them.
“I tried quitting once with the patches but didn’t like them,” said Cpl. Renard Gibson, aircraft maintenance administration for Marine Medium Helicopter Squadron 364. “The everyday routine of smoking was the hardest thing to break. I think it helps to have a coach online to help you fight the urge of smoking.”
Service members often have demanding schedules, so the online support system can be readily available for those who have web-enabled phones.
“It won’t take as much time during the day to go online,” Gibson said. “It’s easier to check your phone to stay on track, than to schedule an appointment.”
The website provides medication information, news articles, podcasts, widget updates and special monthly features to keep the TRICARE members informed and motivated.
A 2005 study by the American Lung Association showed 32 percent of active duty service members smoke. More than 23 percent of current service members plan to quit smoking within the next month, and 40 percent more plan to quit within the next six months, according to a 2008 DoD survey of health related behaviors.
“We now know tobacco is a hazardous substance and the number one cause of preventable death in the U.S. So we do our very best in the military health systems to discourage people from taking up tobacco use and support tobacco users in quitting if they are motivated to do so,” said Dr. Jack Smith, acting deputy assistant secretary of defense for clinical and program policy and acting chief medical officer, TRICARE management activity.
The Food and Drug Administration will require use of a “cancerous lesion on lip” image in cigarette advertising and packaging for its potential to motivate positive behavioral change, influence youth and young adults in particular and inform the public that cigarettes cause oral cancer.
Flexing its regulatory muscle on the second anniversary of the Family Smoking Prevention and Tobacco Control Act, which was signed into law June 22, 2009, the FDA unveiled nine graphic health warnings to be placed on all cigarette packs, cartons and ads no later than Sept. 22, 2012.
“The nine new health warning statements and the accompanying graphic images selected by FDA convey information that is factual and uncontroversial,” the agency said in the regulatory notice.
The FDA simultaneously announced a public inquiry and request for comments on the public health impact of modified risk tobacco products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. The FDA scheduled a public forum Aug. 25-26 to obtain information on “the scientific issues associated with assessment and ongoing review of MRTPs.” These include smokeless and other products promoted as alternatives to cigarette smoking.
The Association supported the 2009 tobacco control law, and has advised the FDA on using the law to shape public tobacco policy. “Dentists are the first line of defense in the war against oral cancer and many other tobacco-related diseases,” the Association told the FDA in commenting on tobacco product regulation.
“As a matter of public health, we have become increasingly alarmed by recent attempts to market smokeless tobacco as a healthier (or less harmful) alternative to cigarettes,” the Association’s Oct. 9, 2009 statement said. “Smokeless tobacco is not a healthy alternative to cigarette smoking; both products pose health risks.”
FDA issued the requirement for larger, graphic health warnings for cigarette packages and advertisements in a June 22, 2011 Federal Register document dense with analysis and research rejecting tobacco industry arguments against the proposal and explaining how and why these images and warnings will get public attention and reduce smoking-related disease and death.
An image the FDA describes as “cancerous lesion on lip” will illustrate a “WARNING: Cigarettes cause cancer” statement chosen, the agency said, for scoring high in focus group testing on emotional and cognitive reaction scales and a “difficult to look at” measure.
“First, ‘cancerous lesion on lip’ was the only image among the images proposed for use with this warning statement that had a positive impact on beliefs about the health risks of smoking and secondhand smoke exposure in one of the study samples (adults viewing a hypothetical advertisement),” the FDA said in the regulatory document.
“Furthermore, as is stated in several comments…the selected image ‘cancerous lesion on lip’ is likely to have particular relevance for youth. As explained in some of these comments, the research literature suggests that youth are likely to relate to and be susceptible to cigarette warnings depicting the negative short-term impacts of smoking on their personal appearance, including their lips and teeth.
“Several comments noted that the image could be especially effective with younger audiences and could positively influence such audiences by illustrating how the health effects caused by smoking negatively affect their physical appearance. The comments indicated that adolescents can relate to and will be susceptible to this message.
“We agree with these comments,” the FDA said in responding to the comments on image effectiveness. “It is important to include content in the required warnings that is relevant to youth. The image ‘cancerous lesion on lip’ has the potential to positively impact youth behavior in addition to adult and young adult behavior.”
The FDA disagreed with comments that the image was “too gross” to be effective and that oral cancer was an odd choice of cancers to depict in the graphic warning, noting that “the research literature indicates that images that evoke strong emotional reactions can promote greater awareness and better recollection of the health risks of smoking and can increase the likelihood smokers will reduce their smoking, make an attempt to quit, or quit altogether.
“Furthermore, the choice of cancers depicted in the required warning is appropriate and will help inform the public that cigarettes cause oral cancers and thus increase public awareness of the negative consequences of smoking.”
Smokers nationwide have deluged quit lines in the days since the Food and Drug Administration announced that cigarette packs must carry labels with nine new graphic photos beginning in fall 2012.
The American Lung Association has reported triple-digit jumps in the number of calls for help to some state hotlines, including one state where calls were up 200 percent.
"I think it's very fair to say the increase in calls came as a result of the announcement of the new warning labels," said Erika Sward, the association's director of national advocacy.
The FDA estimates 213,000 people will quit smoking as a result of the new emphasis on the hazards of smoking. Images — including those of a man smoking through a hole in his throat and diseased lungs — will cover each cigarette package, which also will display a toll-free number, "800-QUIT-NOW."
That number will put smokers in touch with quit lines in their states.
"What we have seen is, if you tell smokers about (the graphic labels), they are going to call the number. It's important for states to put more funds into their quit lines between now and next fall," Sward said. "The worst thing that can happen is no one is there when someone is ready to quit."
The state's Department of Public Health funds the Illinois Tobacco Quitline, "866-QUIT-YES," which provides access to registered nurses, registered respiratory therapists and counselors.
The Cook County Department of Public Health reports that children are more likely to start smoking if they have a parent who does and that most smokers report developing their habit at age 13 or 14.
The American Lung Association hopes the new labels and the quit lines will put a dent in these numbers.
"We want to see the highest number of people get the help they need to quit as result of these labels and we want kids to never start. This is one step on the way to what we know is needed to stop this terrible thing from happening," Sward said.
The Centers for Medicare and Medicaid Services has informed state Medicaid directors of new smoking cessation services and reminded them that Medicaid programs are now required to fully cover those services for pregnant women.
The Centers for Disease Control estimates that smoking results in more than $96 billion in healthcare services annually and costs another $97 billion in lost productivity. While 45 of 51 Medicaid programs already offer some form of smoking cessation services or coverage, most beneficiaries and doctors aren't aware of them. A 2004 study found that 36 percent of Medicaid-enrolled smokers and 60 percent of Medicaid physicians knew that their state Medicaid program offered any coverage for tobacco-dependence treatment.
CMS also wants to increase awareness among doctors and pregnant women that these benefits are now required by law under health reform.
“In pregnant women, smoking can cause serious complications,” said CMS Administrator Donald M. Berwick, MD, in a blog post touting the new regulations. “Babies born to mothers who smoke are more likely to be lower birth weight, have lung problems and other health problems. They’re more likely to die from sudden infant death syndrome.”
To help get the word out to all Medicaid-covered smokers, CMS is making federal Medicaid matching funds available to states for the costs associated with telephone services.
“We urge all states to offer comprehensive cessation benefits, including telephone quitlines, to all Medicaid recipients and to aggressively promote the availability of the services in order to achieve the maximum public health benefit,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement. “There is strong evidence that Medicaid coverage to help smokers quit is highly cost-effective and saves money.”
Myers cited a Massachusetts program, which has provided Medicaid coverage of smoking cessation services since 2006, that saw a 26 percent decline in the smoking rate among beneficiaries in the first two-and-a-half years. Those who used the benefit also showed a 46 percent decrease in hospitalizations for heart attacks and a 49 percent decrease in hospitalizations for cardiovascular disease.
To help guide the states in covering smoking cessation programs and treatments, CMS is recommending guidelines proposed in a May 2008 Public Health Service report, “Treating Tobacco Use and Dependence: 2008 Update: A Clinical Practice Guideline.”
According to that report:
For pregnant individuals, the report indicates:
According to a report from the Congressional Budget Office, providing smoking cessation benefits, which don’t include co-payments, can positively impact a state’s Medicaid program. A 2007 study by the American Legacy Foundation estimated that if all smokers enrolled in Medicaid programs stopped smoking, the Medicaid program would save $9.7 billion after five years.