New Year FDA meeting on dissolvable products

he US Food and Drug Administration’s Tobacco Products Scientific Advisory Committee is to hold a meeting in the New Year to continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on public health.

The meeting, to be held on January 18-20, will include discussions on the composition and characteristics of dissolvable tobacco products, their use, potential health effects, and marketing.
tobaccoreporter.com

Santa Monicans react to new graphic cigarette warning labels

MID-CITY — Purchase a pack of cigarettes and get a blackened lung, rotten teeth or an oxygen mask — these are just a few of nine health warninggraphic warning labels the FDA unveiled recently in what was the most significant change to cigarette labels in the last 25 years.
While the bold new warning labels, which will cover 50 percent of cigarette packaging, won’t appear in packs of smokes until 2012, residents are already reacting to them, and those reactions are mixed.
Michael G. saw a sampling of the labels last week shortly after purchasing a Big Gulp at a 7-Eleven on Santa Monica Boulevard.
“I think they’re ridiculous,” he said. “They’re no deterrent. Anyone who smokes already knows what it does to them. I’m hooked, I’m done and I’ve been smoking for a third of my life, so this isn’t going to do anything to me. I already know this.”
While the FDA is implementing these new warnings to help prevent children from smoking and help adults quit, he doesn’t have full hope about its purpose for children.
“It may be a deterrent for children, but unfortunately just like any other kid who started smoking, it’s through peer pressure,” said the 44-year-old carpenter, who was peer pressured into taking his father’s pack of Pall Malls when he was young.
For 29-year-old computer programmer Carlos Montes, the warning labels do exactly what the FDA is aiming for.
“If I were to buy cigarettes, I wouldn’t want to see that and would not buy them. I would not want that to happen to me,” said Montes, reacting to an image of rotten teeth.
Walking on Ocean Park Boulevard with his sandwich and headed back to work, Montes started to lose his appetite on the second disturbing photo he saw.
“I just don’t want to see it. I don’t like them at all. I guess I’m supposed to link that smoking is a cause of their death? I think this is a post-autopsy? Scary,” he said about a warning label depicting a man on his death bed with a stapled chest.
Elizabeth Taubman is less hesitant and quick in her response to the FDA’s image of the man.
“Perfect. That would scare the … out of anyone,” said the 58-year-old musician.
Scaring people straight is the purpose, said Health and Human Services Secretary Kathleen Sebelius.
“These labels are frank, powerful depictions of the health risks of smoking,” she said.
If the labels are real images of the risks of smoking, then the FDA’s mission with these labels fulfills its purpose for Taubman.
“It’s disturbing, extremely disturbing because if that’s what cigarettes do to you, then I would never be interested,” said Taubman.
Store manager Ryan Marker, 32, also believes they are terrifying, but isn’t sure about how effective they may be.
“I think scare tactics are always a problem,” he said. “These facts have always been around for a while, pictures are always effective … granted, but fear tactics, well, they don’t work with me. Personally, I’m horrified by them but I don’t smoke and I don’t know how others will turn around on that.”
Marker is uncertain about the future for this bold measure in the U.S., but other countries like Canada that require these similar labels on cigarette cartons know the positive impact it’s had. Canada required tobacco manufacturers to include graphic warning labels in 2000.
According to a Canadian Community Health Survey from 2009, smoking rates in Canada declined; the smoking rate for men was 23 percent compared with 28 percent in 2001. Among women, the rate was 18 percent, down from 24 percent in 2001.
A Santa Monica worker and Venice resident who used to live in Canada a few years ago attributes the Canadian decline in cigarette smoking to the labels.
Bob, a 35-year-old film editor who didn’t want to give his last name, said he was a smoker before living in Canada and quit during his time there. He credits the labels.
“I think they’re effective,” he said. “I used to smoke when I lived in Canada a few years ago and seeing that versus the warning labels we have, makes a difference.”
In recent years, more than 30 countries or jurisdictions have introduced labels similar to those created by the FDA. The World Health Organization said in a survey done in countries with graphic labels that a majority of smokers noticed the warnings and more than 25 percent said the warnings led them to consider quitting.
The FDA estimates the labels will cut the number of smokers by 213,000 in 2013, with smaller additional reductions through 2031.
By Jessica Jung
news@smdp.com

Menthol Cigarette Investigation to be Conducted by FDA

A menthol cigarette independent review is part of the Food and Drug Administration’s latest investigation into the public health impact of cigarettes.
The FDA said Monday that members of its Center for Tobacco Products will gather menthol studies and then submit its review to an external peer review panel next month. The cycle should be completed by fall of 2011, at which point the results of the review will be available for public comment.
The investigation is motivated by a report from the Tobacco Products Scientific Advisory Committee, who noted that the minty flavoring of menthols has led to an increase in smokers, particularly among teens, African Americans, and those with low incomes. The report also noted that while menthol cigarettes are harder to quit, smokers that choose menthol are not likely to be at a higher risk of disease or exposed to a greater number of toxins.
A ban or other restriction on the sale of flavored cigarettes would have the most impact on Lorillard Inc., whose Newport brand is the highest-selling menthol cigarette in the United States, with roughly 35 percent of the market.
Menthol cigarettes are one of the few growth areas in a shrinking cigarette market: the percentage of smokers using menthol brands grew from 31 percent in 2004 to 33.9 percent in 2008, according to a study by the federal Substance Abuse and Mental Health Services Administration, with the largest growth among younger smokers.
A tobacco industry report to the FDA conceded that all cigarettes are dangerous but says there’s no scientific basis for regulating menthols differently.

Why the FDA Must Ban Menthol Cigarettes

The U.S. Food and Drug Administration is currently considering a ban on the sale and distribution of menthol cigarettes in the United States—a measure that could save thousands of lives each year and drastically cut elevated smoking-related health problems experienced by African Americans as well as lesbian, gay, bisexual, and transgender Americans who often bear the brunt of smoking-related diseases. For so many reasons, this ban is a no-brainer.
In 2009 Congress directed the FDA to ban all other candy-, fruit-, and spice-flavored cigarettes but they fell short of eliminating menthol flavoring—even though it was believed to be the most widely used and highly addictive of all flavored cigarette additives. Instead, they mandated a comprehensive study to assess the impact of menthol smoking on the health of the general public, especially among our nation’s youth and minorities who smoke menthol cigarettes at the highest rates.
Now, the findings are in and the evidence is conclusive. Menthol cigarettes are hazardous to the public health and should be removed from the marketplace. According to the independent Tobacco Products Scientific Advisory Committee, which performed the study and made recommendations to the FDA last month:

  • Removing menthol cigarettes from the marketplace would greatly benefit the public health.
  • Menthol cigarettes lead to a lifetime of smoking.
  • Smokers of menthol cigarettes find it easier to start and more difficult to quit smoking.
  • Menthol deceives users into the false perception that menthol cigarettes are less harmful than nonmenthol cigarettes.
  • The availability of menthol increases the prevalence of smoking among African Americans.
  • Predatory marketing by tobacco companies to youth, African Americans, and Hispanics also leads to the high prevalence of menthol smoking among these populations.

The need for a menthol ban is further evident when exploring the impact of smoking on gay and transgender Americans. Research shows that gays and transgenders smoke at rates up to twice that of the general U.S. population. And it is estimated that lesbians, gays, and bisexuals are 30 percent to 200 percent more likely to smoke than the rest of the American public, a rate higher than that of all the groups evaluated in the Tobacco Products Scientific Advisory Committee study. Alas, no comprehensive data are available on how many gay and transgender Americans smoke menthol-flavored cigarettes or suffer the consequences because national health surveys, and most state-based surveys, too, lack questions of sexual orientation or gender identity. Nonetheless, we can deduce that gays, lesbians, bisexuals, and transgenders are just as vulnerable to smoking-related disparities as African Americans and other ethnic minority groups, which is why they should also be treated as a special population in federal health studies.
Certainly, both groups would benefit from a ban on menthol for generations to come. And this is especially the case for gay and transgender people of color, for whom the scourge of smoking menthol-flavored cigarettes only compounds this assault on their health. This issue brief will look at the parallels in smoking-related health “disparities”—health care parlance for elevated ill health among different groups of Americans—faced by adolescents, gays and transgenders, and African Americans; examine why they occur; and highlight how a ban on menthol cigarettes will help bridge the health and wellness gap for everyone.
Menthol perpetuates extreme health disparities
All cigarettes, of course, are dangerous. Smoking is the single-most preventable cause of disease, disability, and death in the United States. Each year an estimated 443,000 people die prematurely from smoking or exposure to secondhand smoke, and another 8.6 million live with a serious illness caused by smoking.
Mortality rates are even more tragic for African Americans and gay and transgender smokers who suffer the greatest consequences of tobacco-related illnesses alongside already elevated rates of obesity, high blood pressure, cancer, and other diseases that are inflamed by smoking. Blacks, for example, are more likely to acquire and die from lung cancer than any other group of Americans, and the American Cancer Society estimates that a minimum of 30,000 gay and transgender Americans die each year of tobacco-related diseases. Rates are similar for strokes and heart disease. For gay and transgender African Americans, the risk is surely even greater.
Mounting evidence suggests that the availability of menthol cigarettes perpetuates the high rates of smoking among these minority groups, which result in these bleak health outcomes. There are currently 19.2 million menthol smokers in the United States, and more than a million of these smokers are adolescents between the ages of 12 and 17.
menthol study
More than 80 percent of all black youth who smoke use menthol—the highest usage among all minority groups—and more than 70 percent of gay and transgender youth smoke menthol cigarettes—also among the highest usage of all groups within this age group.
The most effective way to tackle these appalling figures is to reduce the number of people who begin smoking in the first place. A ban on menthol cigarettes would effectively do just that. Here are the reasons why.

Menthol cigarettes are a starter product for youth

Smoking and nicotine addiction is a pediatric epidemic, with nearly 80 percent of smokers having their first cigarette before the age of 18, and with one in three youth smokers projected to die prematurely from tobacco-related diseases. Research suggests that menthol cigarettes are the culprit, as menthol use is up almost 20 percent among youth despite a decline in smoking among the public overall.
Black, gay, and transgender adolescents account for a significant portion of this increase. They smoke menthol cigarettes at rates considerably higher than the rest of their peers
mentholuse
It’s not surprising that 50 percent of all youth who smoke cigarettes smoke menthols. Tobacco companies have long understood the allure of menthol to young smokers and have manipulated the levels of menthol in cigarettes to appeal to them. The minty flavor and cooling sensation masks the harsh tobacco taste and the peppermint effect eases inhalation, making cigarette use more palatable for youth and first-time smokers.
This early exposure to menthol cigarettes contributes to the high rate of smoking-related illnesses and premature mortality within the general public, and among African Americans, gays, and transgenders in particular. That’s why youth prevention is essential to reducing chronic smoking-related diseases among the general public. Eliminating menthol from the marketplace will drastically reduce the number of young people initiated into smoking that grow up to be lifelong smokers, which will ultimately save an entire generation from such harsh outcomes.
Predatory marketing by tobacco companies
Contrary to claims by the tobacco industry, elevated rates of menthol use among these groups of Americans are not merely coincidental or a simple matter of smoker preference. Decades of tobacco industry documents reveal that African Americans, adolescents ages 12 to 17, and gay and transgender communities have all been targets of aggressive marketing tactics by cigarette companies who worked to position smoking as a cultural norm among these groups.
These campaigns more often than not were designed to perpetuate stereotypes and exploit vulnerabilities of each of these communities. The tobacco industry continues these campaigns despite heavy criticism over the years for their predatory nature. This is why continued high levels of smoking among minority groups is now more than just a health and wellness issue but also one of social justice and consumer protection.
Tobacco industry marketing tactics, for example, are historically condescending and downright offensive to minority groups who are also the most loyal customers. R.J. Reynolds Tobacco Company, for one, has painted African Americans as naturally unhealthy, disinterested in self-improvement, and unmotivated to do anything other than try and impress others. They’ve also targeted the Bay Area gay community through a campaign called Project SCUM, the name alone quite telling of the sentiment toward the community.
Moreover, youth of color under the age of 18 are cited by the industry as a primary target, with menthol products heavily marketed to this group of Americans in order to loop them into smoking. The tobacco industry is preying on the next generation of customers and society is paying the price.
The focus on gay and transgender smokers
Tobacco companies overtly target gay and transgender Americans in campaigns to hook them early and convert them into lifetime customers. And the high smoking rates of this group suggest the tobacco merchants are winning. Smoking among gays and transgenders is a health crisis, which is why policymakers must work now to develop culturally competent intervention programs and succession models to reverse the trend.
A handful of state-based and privately funded studies offer us some insight on the root of such widespread smoking in the gay and transgender community. The American Lung Association’s compilation of research, for example, finds possible contributing factors to be associated with:

  • The stress and discrimination related to homophobia
  • The tobacco industry’s targeted marketing to gay and transgender customers
  • The lack of access to culturally appropriate tobacco treatment programs

Smoking becomes a coping mechanism to help them deal with these issues—issues that are further magnified for gay and transgender people of color who face discrimination due to both race and sexual orientation or gender identity.
Moreover, gays and transgenders disproportionately socialize in bars and clubs where they face less discrimination but where smoking remains prevalent. For many in this community, bars and clubs are often the only social outlets they have to connect with other members of the community, so whether smokers or not, they are still subject to the harms of secondhand smoke.
Whatever the case, we know smoking is highest among gay and transgender Americans, with rates ranging between 25 percent and 50 percent. A recent report also found that 30 percent of transgender Americans report smoking daily or occasionally, compared to just 20.6 percent of all U.S. adults.
Additionally, lesbians and bisexual women are the only group of women whose smoking rates exceed their male counterparts. In the general population men smoke much more than women, but one study found that lesbian and bisexual female youth were more than nine times more likely than their heterosexual classmates to have smoked in the last week. There was no difference found between smoking among gay or bisexual male youth and their straight classmates.
Ban menthol cigarettes and most users would quit
The magnitude of the harm caused by the availability of menthol to the public health is striking. According to the independent Tobacco Products Scientific Advisory Committee estimates, 9 million more people will start smoking over the next 40 years due to the availability of menthol cigarettes. If trends hold true, we can then anticipate that the majority of these new smokers will be black, gay, or transgender. This is well beyond the number of new smokers that would take up the habit, whether menthol were available or not.
Should menthol remain on the market, more than 325,000 premature deaths will also result and millions will be faced with the excess burden of morbidity stemming from chronic diseases, infectious diseases, and diminished well-being that is attributable to smoking.
The good news is that the majority of menthol smokers report that they will stop smoking altogether should the FDA ban menthol cigarettes. A study by the National Cancer Institute found that almost half of African Americans polled said they would quit smoking and not use any other tobacco product if menthol were banned. Seventy percent of transgender smokers reported the same. No data is available on cessation plans of lesbian, gay, or bisexual smokers.
In summary, a ban on menthol would avert more than 300,000 premature deaths and divert 9 million people away from smoking over 50 years. It would also lead to a 50 percent reduction in the smoking prevalence among African Americans and a 70 percent reduction for transgender Americans—saving lives, bridging health and wellness gaps among minorities, and reducing health care spending across our nation. This is a win-win for every American.
By Aisha C. Moodie-Mills

The case against menthols

Menthol cigarettes are “cool” — literally and figuratively. They soften the harshness of tobacco smoke, and their popularity continues Newport menthol cigarettesto increase, particularly among young people and African Americans. Some health experts feel it’s high time they were banned.
This month, a scientific advisory panel for the U.S. Food and Drug Administration delivered a 231-page report on the public-health risks of menthol cigarettes after reviewing scientific literature and seeking comment from researchers and the tobacco industry. The panel’s bottom line: “Because there are menthol cigarettes, we have more smokers,” says Dr. Jonathan Samet, an expert in pulmonary medicine and environmental health at USC, who was chairman of the committee.
Here’s a closer look at how menthol cigarettes differ from regular cigarettes and why tobacco-control advocates want them outlawed.
What is menthol and what does it do in cigarettes?
Menthol is a naturally occurring aromatic compound — it can also be synthesized in labs — that has cooling, anti-itch and pain-relieving properties. It’s found in a variety of products, including throat lozenges and chest rubs for colds.
Most cigarettes have some menthol. The FDA’s current focus is on brands specifically marketed as menthol cigarettes, such as Newport, Kool, cigarette-store.biz/online/marlboro, cigarette-store.biz/online/camel and Salem, which contain significantly more.
Adding this much menthol to cigarettes reduces the harshness of smoke and blunts the irritating effect of nicotine in the airways.

Why has menthol been treated differently from other cigarette flavors, which were banned in 2009?

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate the manufacture and marketing of tobacco products. Later that year, the agency banned the sale of candy-, fruit-, and clove-flavored cigarettes. Though menthol cigarettes were not included at that time, the legislation charged the FDA with putting together a comprehensive review of the products, which the panel has now done.
Peter Jacobson, a professor of health law and policy at the University of Michigan in Ann Arbor, says that menthol is a much bigger target involving much bigger tobacco companies. “The FDA was smart to not take everything at once. It’s given the agency time to build momentum and to build a body of evidence,” he said.
Are menthol cigarettes a bigger health risk than regular cigarettes?
Samet says the panel looked at two possible ways that menthol cigarettes might pose a greater risk to public health, and found significant supporting evidence for one of them.
First, they examined whether adding menthol makes cigarettes more dangerous for individual smokers, perhaps by delivering a higher dose of nicotine or other toxic chemicals in the smoke, or causing higher rates of smoking-related diseases. The panel found insufficient evidence to make that case.
Concurring with the panel’s conclusion, a study published last week in the Journal of the National Cancer Institute found that lung cancer rates were actually lower in people who smoked menthol cigarettes than in those who smoked nonmenthol cigarettes. The researchers selected 440 lung cancer patients and 2,213 control subjects — matched for age, race and gender but without lung cancer — from a much larger population study of 85,806 people living in the Southern U.S. They found that menthol smokers were 12 times more likely to have lung cancer than nonsmokers, whereas nonmenthol smokers were 21 times more likely to have cancer.
The second way that menthol cigarettes might cause more harm than regular cigarettes would be if they increased smoking rates. The panel did find evidence for this, particularly in younger smokers.
Samet says research shows that with menthol cigarettes, a teen experimenting with smoking is more likely to become a regular smoker and then an addicted smoker. And these young years are crucial for establishing or not establishing a habit.
“During those formative years — that’s when the uptake of cigarette smoke really may lead to more dependence,” says Dorothy Hatsukami, professor of cancer prevention and psychiatry at the University of Minnesota in Minneapolis, who also served on the FDA panel.
In the case of adults, the science says that nonwhite populations had more difficulty quitting smoking if they smoked menthols compared with people who smoked nonmenthol cigarettes. African Americans favor menthol cigarettes more than any other demographic: More than 80% use them.

So what’s the upshot? Will menthol cigarettes be banned?

It’s unclear. Although the advisory panel concluded that banning menthol cigarettes would benefit public health, it did not explicitly recommend that step. The FDA has yet to review the report and may consider ways to restrict menthol cigarettes short of an outright ban. It has set no timeline for making a decision.
By Jill U. Adams, health@latimes.com

FDA's Regulatory Agenda in 2011

FDAThe Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted in June of 2009 and granted the FDA the authority to regulate cigarettes, roll-your-own tobacco and smokeless tobacco products. Under this law, the FDA has been issuing and implementing various tobacco regulations. This year, there are several major regulations under consideration by the FDA’s Center for Tobacco Products.
The Tobacco Control Act does not require tobacco retailers to implement a clerk training program. However, in July of 2010, the FDA issued what is called a “guidance” document that sets forth recommended elements for a training program. The FDA accepted public comments on the proposed training program elements, and should be issuing a final set of recommended elements soon. If a retailer uses a training program that meets the FDA recommended requirements, then a lower penalty structure will apply if a clerk violates the law and sells tobacco products to an under-aged individual.
As a part of the FDA’s implementation of retail tobacco regulations, the Tobacco Control Act granted the FDA the authority to contract with states to perform surveillance inspections and compliance checks in retail stores. While the FDA intends to contract with every state to assist in inspecting tobacco retailers, to date the FDA has contracted with Alabama, Arkansas, Arizona, Colorado, Idaho, Illinois, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Pennsylvania, Tennessee and Washington. The first round of inspections recently occurred in Mississippi and 95% of 493 Mississippi inspected retailers passed the compliance checks.
A third major regulatory action by the FDA this year will be a decision on what action to take, if any, on menthol cigarettes. The Tobacco Control Act banned all flavored cigarettes, except menthol cigarettes. However, the law also established the Tobacco Product Scientific Advisory Committee (TPSAC) to study the “impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.” A report by the TPSAC, with its recommendation on menthol cigarettes, will be submitted to the FDA by the end of March 2011.
One other significant regulatory action by the FDA is the requirement that new text health warnings accompanied by graphic pictures be printed on the top half of the front and back of cigarette packages. The FDA law requires that nine new text health warnings appear on a rotating basis on cigarette packages. These new text warnings will replace the current Surgeon General’s health warnings that appear on cigarette packages.
The wording for each of the nine new warnings is as follows:

  • WARNING: Cigarettes are addictive
  • WARNING: Cigarettes cause cancer
  • WARNING: Tobacco smoke can harm your children
  • WARNING: Cigarettes cause fatal lung disease
  • WARNING: Cigarettes cause strokes and heart disease
  • WARNING: Smoking during pregnancy can harm your baby
  • WARNING: Smoking can kill you
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers
  • WARNING: Quitting smoking now greatly reduces serious risks to your health

Each of these new text warning labels will need to be accompanied by a pictorial health warning that shows the health consequences of smoking. The FDA has proposed 36 different color graphic health warning pictures, and will select nine of the 36 pictures to print on cigarette packages.
The following list contains what the Agency and Commissioner hope to spend most of their time on in 2011:
Advertising:
• Standards for making comparative claims in prescription drug promotion
• DTC television advertisements—FDA Amendments Act of 2007 DTC Television Pre-Review Program, with particular emphasis on how the Agency intends to address the issue of certifying the legality and safety of content for TV ads going forward. FDA has been harshly criticized by consumer groups for acting with ambivalence in this key area of drug promotion.
• Promotion of prescription drug products using social media tools. This includes creating clear guidelines in setting legal boundaries between what may constitute a simple exchange of information and commercially oriented promotion.
Clinical/Medical:
• defining oncology endpoints in clinical trials for non-small cell lung cancer
• General clinical pharmacology consideration for pediatric studies for drugs and biological products
Clinical/Statistical:
• standards for superiority in adaptive trial designs

Combination Products:

• building a clear regulatory pathway for incorporating drug diagnostics in co-development programs with small molecules and biologics.
Current Good Manufacturing Practices Compliance:
• Importation of active pharmaceutical ingredients for use in human drugs, standards to enhance safety and efficacy in international trade.
Drug Safety Information:
• Best practices for conducting pharmacovigilance studies using electronic healthcare data
The list should not be seen as exhaustive or definitive—given the Agency’s vast remit, priorities can shift or be overtaken by events. In that regard, the list includes enough new initiatives in areas outside the remit of pharmaceutical regulation—such as food safety—to suggest FDA resources will continue to be stretched to the limit next year. This guidance will also need to pass muster with the new GOP majority in the House of Representatives, which is likely to tone down any hint of regulatory activism in the Agency as it moves forward.
For the complete agenda, please visit the Federal Register website entry for December 7, 2010.

FDA can regulate Electronic Cigarettes as Tobacco Products

A federal appeals court says electronic cigarettes should be regulated as tobacco products by the Food and Drug Administration rather than as drug-delivery devices, which have more stringent requirements.
The ruling means their makers won’t have to conduct expensive clinical trials to prove to the FDA that the products are safe and effective as a stop-smoking aid.
The decision is a setback to the FDA and other public health organizations, which had argued e-cigarettes should be regulated like nicotine replacement gum or patches. They also have warned that e-cigarettes contain dangerous chemicals and are being marketed to children.
A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency’s authority over tobacco, which means they would follow the same restrictions as traditional cigarettes and tobacco products.
Some sellers of e-cigarettes sued the FDA last year after the agency told customs officials to refuse entry of shipments into the U.S. A federal judge ruled in January that the FDA can’t stop those shipments, saying the agency had overstepped its authority.
E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the “smoker” inhales. A tiny light on the tip even glows like a real cigarette.
Nearly 46 million Americans smoke traditional cigarettes. About 40 percent try to quit cold turkey or with other nicotine replacements each year, according to the Centers for Disease Control and Prevention. But unlike patches or gums, e-smokes have operated in a legal gray area.
Users and distributors say e-cigarettes address both the nicotine addiction and the behavioral aspects of smoking — the holding of the cigarette, the puffing, seeing the smoke come out and the hand motion — without the more than 4,000 chemicals found in a traditional cigarette.
First marketed worldwide in 2002 as an alternative to regular cigarettes, e-cigarettes didn’t become easily available in the U.S. until late 2006. Now, the industry has grown from the thousands in 2006 to several million worldwide, with estimated 20,000 to 30,000 new e-smokers every week, according to Jason Healy, the president of e-cigarette maker Blu Cigs.
The FDA said the agency is reviewing the opinion and considering its next steps.
“We can now market our product the way we always should have been able to,” Matt Salmon, the newly tapped CEO of Sottera Inc., which markets NJOY-branded electronic cigarettes, said in an interview with The Associated Press. “This is plain and simple an alternative to smoking for committed, longtime smokers.”
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids said in a statement that the decision will allow “any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time.”
“This ruling invites the creation of a wild west of products containing highly addictive nicotine,” Myers said, urging the FDA to appeal the decision to the Supreme Court.
American Heart Association CEO Nancy Brown also voiced concern over the ruling.
“There is no scientific evidence that e-cigarettes are effective smoking cessation devices and, until they undergo rigorous evaluation by the Food and Drug Administration, they should be pulled from the marketplace,” she said in a statement.
In September, the FDA issued warning letters to several makers of electronic cigarettes or its components, saying the companies are violating the law with unsubstantiated health claims and poor manufacturing practices.
The FDA also has said that its tests found the liquid in some electronic cigarettes contained toxic substances — besides nicotine, which is itself toxic in large doses — as well as carcinogens that occur naturally in tobacco. Most e-cigarettes are imported from overseas.
However, some public health experts say the level of those carcinogens was comparable to those found in nicotine replacement therapy, because the nicotine in all of the products is extracted from tobacco.
By MICHAEL FELBERBAUM

Altria vs. the FDA: More than a Mild Dispute

Marlboro Lights are no more. From now on smokers will have to ask for cigs4us.biz/marlboro-cigarette/marlboro-lights. Corporations do not change iconic brands lightly. In this case cigarette manufacturer Altria Group (MO) had no choice. The Food & Drug Administration, which as of last year regulates tobacco products, banned the use of the words “mild,” “light,” or “low tar” on packages effective on June 22. The agency says such cigarettes are just as harmful as regular ones.
Before Altria made the switch, it used the old packs to tell smokers that while the look of, the “cigarette stays the same.” That got the FDA’s attention.
The agency argues many consumers will continue to assume Marlboro Golds are safer than regular smokes and has ordered Altria to hand over market research showing why it used the tactic. “What we’re concerned about is that it is potentially perpetuating this untruth that these products are somehow less harmful,” says Dr. Lawrence R. Deyton, the agency’s top tobacco regulator. Altria spokesman Bill Phelps says the company will cooperate with the agency.
Pharmaceutical companies frequently skirmish with the FDA, and Big Tobacco is widely expected to do the same. Altria was the only cigarette maker to support FDA oversight, says Phelps, because it wanted consistent rules of the game for the entire tobacco industry.
Still, this is the second time Altria has clashed with federal regulators in recent months. In March it challenged the membership of an FDA tobacco science panel studying the health risks of menthol cigarettes, which account for more than a quarter of U.S. cigarette shipments. If the panel deems that menthol increases the risk for smokers, the FDA could ban such cigarettes.
On Mar. 22, Altria sent the FDA a 16-page letter requesting the removal of four members of the 12-person panel. The company noted that the four had testified in more than 90 legal cases against the tobacco industry and said that as paid expert witnesses they had “grave financial conflicts and intellectual bias.” One of the panelists, Gregory N. Connolly, a tobacco specialist at the Harvard School of Public Health, contends he hasn’t been an expert witness in five years and that his research makes him uniquely qualified for the panel. “I take umbrage at Altria’s challenge,” he says. The three other panelists cited in Altria’s letter did not return calls seeking comment. The FDA rejected Altria’s request to have the four removed.
Some health-care policy experts and officials at anti-tobacco groups say Altria’s challenge to the FDA may be only the first in a series of battles between Big Tobacco and the government. “This is the beginning of a significant series of regulatory actions by the FDA,” says Gregg Haifley, a lobbyist for the American Cancer Society. “The industry will fight this hammer and tong. It will be a titanic fight.”
Tobacco czar Deyton says the industry so far has cooperated with the FDA. He adds, however, that if tobacco companies resist new cigarettes rules and policies, “the law gives [the] FDA quite broad and deep authority to enforce all provisions, everything from issuing warning letters to seizures, injunctions, civil money penalties, criminal investigation—the whole thing.”
Disagreements between Altria and the FDA panel in charge of regulating tobacco could erupt into a full-blown battle.
By Greg Miles, Chris Burritt and Molly Peterson
June 24, 2010

Could FDA Panel Conflict of Interest Endanger Menthol Cigarettes?

At least four groups are now questioning the credibility of a federal advisory panel created to study tobacco product safety, menthol cigaretteschallenging two members with financial ties to drug firms that make smoking cessation products. At issue: Will the duo push to ban menthol ciggys and favor smokeless products?
The issue hit this week when the Center for Responsibility and Ethics in Washington, or CREW, filed a complaint against the FDA’s tobacco advisory panel for conflicts of interest since they have voting members who consult for pharmaceutical companies that work on nicotine delivery products to quit smoking.
The concern is that two members, Jack Henningfield and Neal Benowitz, have an incentive to favor smoking cessation products because they’ve advised drug firms on those products.
“This creates an obvious incentive for these members to ban menthol in cigarettes and create a multi-billion dollar market for more nicotine patches and gum potentially paid for by taxpayers,” says a critic. The menthol issue the advisory committee is considering is huge: Menthol cigarettes make up about one third of the cigarette market and eliminating them would likely shift users to smokeless products, say industry officials.
The FDA has rejected previous conflict charges and Benowitz told the New York Times this week: “My involvement with pharmaceutical companies is aimed at reducing the risk of smoking, quitting smoking
. The aim of the committee is also to reduce the adverse health consequences of tobacco use.”
Besides the left-leaning CREW, the three other opposition groups are the Altria Group, the American Council on Science and Health, and the right-leaning Americans for Limited Government.
Bill Wilson of Americans for Limited Government said that having his and CREW oppose the two appointees on the panel shows how much of a concern there is.
“The odds may be greater of drawing a royal flush in poker than us agreeing on anything but we both know you the FDA shouldn’t have a stacked deck when playing with the taxpayers’ money,” he said. “However, two groups as disparate as ours, Americans for Limited Government, and CREW agree the FDA tobacco panel can’t possibly have a legitimate review of the science surrounding menthol’s use in cigarettes with multiple conflicts of interest by many of the panelists.”
By Paul Bedard, Washington Whispers
June 09, 2010

Remarks to the Tobacco Merchants Association

Let me first thank you for inviting me to take part in your program today.FDA
I am pleased to join you to discuss the implementation of the Family Smoking Prevention and Tobacco Control Act.
It is perhaps fitting that you hear about this historic legislation in a setting like historic Williamsburg.
Let me start by telling you something about myself. Then let’s talk about your products and FDA regulation.
As you heard in my introduction, I have spent the last 30 years working to improve the health of Americans through my work as a physician and through the field of public health.
I trained in and worked in public health well before I became a physician and a researcher.
In graduate public health school, I studied the impact of diseases and behaviors on populations such as tuberculosis in inner cities, schistosmiasis in the Nile delta and lead exposure in infants, as well as tobacco use in the United States.
After receiving my public health degree, I initially worked on Capitol Hill and then continued my work in public health as a member of the Surgeon Generals’ staff in the Ford and then Carter Administrations. I was privileged to work on important public health issues of the day, including clean air, clean water, the health effects of poverty, health manpower issues. Back in 1978, I helped set up the original Office on Smoking and Health in what was then the Department of Health, Education and Welfare.
Later in life, I decided I wanted to become a doctor and went to medical school and completed my internship and residency right at the time when HIV/AIDS was discovered and became a major public health challenge. So in 1987, my medical training started to combine with my public health experience and I went to NIH to train in Infectious Diseases and to conduct AIDS research. I stayed at NIH for about 11 years, during which time I was able to contribute to much of the basic and clinical research that defined HIV and helped test the drugs which we use today to treat people with HIV infection.  During this time, I also continued to be an active clinician both at the NIH and Johns Hopkins.
I left NIH in 1998 to join the leadership team of the largest health care system in the country — the one that delivers care to our nation’s Veterans. I became the head of VA’s HIV/AIDS programs at a time when not many people recognized that VA was and is the largest provider of patient care to people with HIV infection. That was a time when VA began its transformation into a modern integrated health care system which has been proven to deliver the highest quality of care in the Nation. Over time I was asked to take on more responsibility and I became VA’s Chief Public Health Officer in 2006. Among my many responsibilities for our nation’s Veterans was to revitalize the VA’s tobacco cessation programs.
On my watch, Veteran’s tobacco use dropped from 33 to 22 percent.
Again, during this time I continued to practice medicine and became a primary care provider to about 100 Veterans at the Washington, D.C. VA Medical Center.
I love helping deliver medical care to Veterans — there is no group of patients more deserving of the best care we can provide. Let me tell you about one of my patients. I’ll call him Mr. Smith*. I met Mr. Smith in about 1999 and I was his primary care provider. Mr. Smith proudly served in the infantry in Vietnam. He was injured on his 2nd tour of duty, nearly died on the battlefield but was medivac-ed out, and after a long recovery from his wounds, he returned to civilian life.
Vietnam scarred Mr. Smith both physically and mentally. He suffered from PTSD from the horrors of war and his injuries. He began to use drugs and became infected with HIV. His years using drugs also scarred his kidneys so when we first met, Mr. Smith had AIDS, kidney failure — and he was on dialysis.
Mr. Smith entered VA’s drug recovery programs and, because of his determination and the good care he got from VA, he was successfully able to quit using drugs. His HIV infection had hurt his immune system but fortunately, with effective drug treatment, his immune system recovered and his overall health improved.
Despite needing to go to dialysis three times a week Mr. Smith held a job and cared for his family. He was so clinically stable that we began preparing Mr. Smith for a kidney transplant. One of the important criteria to be eligible for transplant is to be drug and tobacco free. He was drug free and although I had encouraged him to quit smoking for many years, the prospect of being free of dialysis gave him even more motivation — so we had been working on helping him quit smoking.
While we prepared to get him on the transplant waiting list, we tried many approaches to help him quit smoking. Mr. Smith was really having a hard time. But he was determined. He told me many times something I have heard over the years from many patients — how much harder it was to quit smoking than it was to quit shooting heroin.
Then around Thanksgiving, he began to lose weight, he developed a cough and a chest X ray showed a mass in his right lung which on biopsy was lung cancer.  Other X-rays showed the lung cancer had spread to his bones.
So, the battlefields of Vietnam didn’t kill him. He came home.
His drug use didn’t kill him – he recovered from that.
His HIV didn’t kill him – his treatments restored his immune system.
His kidney failure didn’t kill him and was being treated.
And Mr. Smith had the possibility of a transplant and a normal life without dialysis.
But for this tough, resilient, determined infantry soldier NONE of that took him out.
Mr. Smith died in January — it was his battle with smoking that finally took out this brave soldier.
So after Commissioner Hamburg asked me to take this job and during the first months I’ve been on the job, I’ve often thought about Mr. Smith and other patients like him. I recognized that this was an opportunity to serve my country by helping to prevent our men, women and children from suffering and dying from tobacco-related disease.
I took this job so there are fewer kids who start to use tobacco. I took this job so fewer families devastated by the early death of a loved one. And I took this job because the public health mandate of the Family Smoking Prevention and Tobacco Control Act is so promising with respect to helping reduce the toll of disease, disability and death caused by tobacco use in this country.
I have been on the job nine months now. I have had a chance to take stock of the status of tobacco use in the United States, and let me give you a quick glimpse of what I see.
I see that more than 400,000 Americans still die unnecessarily each year from diseases related to using tobacco products.
That’s more than all the deaths caused by HIV/AIDS, alcohol use, cocaine use, heroin use, homicides, suicides, motor vehicle crashes, and fires combined.
I see that another 8.6 million Americans have at least one serious illness due to smoking.
I see the 50,000 non-smokers who die each year from exposures attributed to second-hand smoke.
I see that between 20 to 25 percent of American high school students still use tobacco.
I see that 4,000 kids start smoking every single day — and 1,000 of them become regular users.
I see that many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young from diseases directly linked to their tobacco use — lung disease, heart disease and stroke and cancers of the lung, mouth, larynx, esophagus and bladder.
I also see that these kids who are smokers aren’t rummaging around through mom’s purse looking for a stray cigarette. Many are addicted and have product loyalties as pronounced as any adult.
You’re in the tobacco business — you know these choices don’t happen by accident. Recent data show that 43 percent of youth smokers actually prefer one brand of cigarette, Marlboro. In fact, according to CDC, 81 percent of underage smokers preferred the three most heavily advertised brands: Marlboro, Newport, and Camel.
I also see that even today, many smokers falsely believe that terms like “Light” or “Low Tar” mean that those products are less harmful than full flavored cigarettes. Of course, we know that is not true because no data exists that prove the decades of engineering and marketing of products called ‘light’ ‘low’ and ‘mild’ are safer than any other cigarettes. In fact, it has actually been shown because of smokers’ now-proven misperceptions that those products actually reduce motivation to quit tobacco use and keep people smoking longer.
I also see that as states and communities are enacting more indoor clean air laws and increase taxes particularly on cigarettes, new types of tobacco products are being developed. Some of these new products appear, taste like and may be confused for candy by kids.
I see my job at FDA is to address this enormous toll of confusion, suffering, and death caused by the current state of tobacco use in this country.
And frankly, we have a long way to go.
And if we can’t make significant progress, I have failed in my job.
So now let me turn to what we intend to do with this new law at FDA to protect public health.
As I recently wrote in the New England Journal of Medicine with the FDA’s Commissioner and Principal Deputy, the FDA’s public health approach to tobacco regulation has four key elements:

  • reducing the rate of initiation of tobacco use,
  • educating the public,
  • applying regulatory science to the control of tobacco products, and
  • engaging actively with public health partners and industry.

Reducing Initiation: The most effective way to reduce the harm is to deter use altogether.  Stopping addiction before it starts is a key initial priority for FDA.  FDA’s first efforts will focus on restricting the marketing and illegal sales of tobacco products to youth and setting initial standards for additives that facilitate youth use.
We will do so by implementing requirements of the law which places restrictions on marketing and promotion to kids such as setting a national minimum age of 18 for purchases and a minimum pack size of 20 cigarettes, banning free cigarette samples and restricting free smokeless samples, eliminating the brand-name sponsorship of sporting events and concerts and establishing a national enforcement system with States and Territories to deter underage tobacco purchases.
We will do so by regulation of tobacco products themselves. Effective September 22, 2009, FDA banned cigarettes with fruit, candy, and other characterizing flavors. Congress authorized this ban because of clear evidence that these flavors act to encourage youth experimentation, regular use, and addiction.
FDA is also examining the role of menthol flavoring in tobacco use by young people and its specific impact on racial and ethnic minorities. And FDA also has the authority to act on tobacco products other than cigarettes or smokeless tobacco that may lead to addiction and tobacco use by young people.
Educating the Public: Most Americans know generally that tobacco is harmful, l but few know the key facts of how damaging tobacco is to their own health and the health of those around them.  In the Tobacco Control Act, Congress gave FDA the tools to educate the public about the actual ingredients and constituents in tobacco products and the profound consequences of exposure to them.
The law also requires FDA to enforce truth in advertising. As I said before, even today, many smokers falsely believe that terms like “Light” or “Low Tar” indicate that those products are less harmful than other cigarettes.  To correct false impressions about the safety of these and other tobacco products, the law requires that tobacco products that use the terms “light,” “low,” and “mild,” on labels or in advertising can no longer be manufactured after June 22nd without FDA approval.
In addition, under the new law tobacco manufacturers must submit detailed lists of ingredients and constituents to FDA as well as documents and data regarding their safety. This material will enable FDA to publish lists of potentially harmful constituents in tobacco products and their smoke, as required by the new law.
The law also requires FDA to propose new graphic pack warning labels comprising 50 percent of the front and back of each cigarette pack and box and start a new system of health warnings for smokeless tobacco products.
FDA also has the authority to request information and studies conducted by tobacco manufacturers on any topic.
Applying Regulatory Science: There exists a substantial scientific base for each of the areas in which the FDA has been empowered to act.  FDA will build on this base to guide key decisions in tobacco regulation.
A major area of focus is in the approval of “modified risk” products. We expect companies to seek approval for products that have “fewer carcinogens” or are “less toxic.”   In setting standards for approval of these products, FDA is well aware of the public health calamity of “light” and “low” cigarettes that I have mentioned.
The law says that in reviewing applications regarding “modified risk” products, the FDA must be presented with sufficient data to understand the health impact on users and non-users as well as the appeal to young people, who might begin a lifetime of tobacco use. To assist, FDA may request and tobacco companies must provide this data with their applications as well as conduct strict post-market surveillance to verify that the products are reducing tobacco-related morbidity and mortality.
Importantly, the new law sets new public health product standard for FDA’s tobacco product regulations which is more appropriate than FDA’s traditional, ‘safe and effective’ standard.   One of FDA’s most powerful tools is the setting of product standards across a class of tobacco products to reduce addictiveness or harm.
Let me end with a few words about the relationship between FDA and industry.
We at FDA understand that it is never easy for an industry to submit to new regulation. The tobacco industry poses special challenges, and speaking frankly, the industry has a long history of resistance to government action.
And, you may realistically perceive the Tobacco Control Act as a serious threat to the tobacco industry’s long-term interests.
Yet I realize that successful implementation of this law will require engaging the various components of the tobacco industry directly, fairly, and transparently. The design of effective regulatory measures must be based on an understanding of the industry to be regulated. For example, input from a wide variety of tobacco companies helped us in establishing a system for industry registration and listing of tobacco products and industry feedback is important to improvements we intend to make in those systems.
While we are a new part of FDA, we have already established a Small Business Assistance Office, a Call Center to field questions and a Web site which adds new information almost every day.  We’ve held listening sessions with industry representatives, distributors and others and we are organizing a series of moderated discussions throughout the country over the next 18 months.
And I want you to know that understanding and engaging with the tobacco industry is important.  That is why I am here today.
That’s also why I asked Les Weinstein to join me at this meeting. Les is the Center for Tobacco Products Ombudsman.  His job is to help resolve regulatory confusion and problems so that this law can be implemented fairly.
I also asked some other members of my staff to come here, too. Perhaps they could stand up.  Unlike me, they didn’t come here to give a speech — they came to listen.
When I was preparing for this meeting, I realized that as representatives of different parts of the tobacco industry, you each face a choice of walking one of two paths with FDA.
One path is confrontational, to try to block FDA at every turn in implementing this law.
To those on such a path, I can only point out that FDA regulation of tobacco products is the result of a law which passed overwhelmingly by Congress and signed by the President.  It is the law and the FDA has the authority to bring advisory, administrative,or judicial actions, including, for those who ignore the law issuing warning letters, seizures, injunctions, civil money penalties and criminal prosecutions.
And FDA will not hesitate to take these steps when warranted by the facts.
But there is the other path too.  And that path is based on the recognition that the people of the United States expect us to use this law to protect their families and the public health.
I hope you will see value of helping FDA to understand the tobacco industry, and that you will participate in the regulatory process and then comply with the FDA’s policies to reduce the devastating harm that tobacco causes for millions of American families.
In my career, I have witnessed what happens when we apply science to public health challenges.  In the case of HIV, through the application of science, what was once a uniformly fatal infectious disease is now largely a manageable chronic condition.
It is my hope that tobacco will become another example of how the application of excellence in science will have a major impact on the public health.
Thank you for your attention.
Dr. Lawrence Deyton, Fda.go