Food and Drug Administration

New Legislation may Weaken FDA’s Regulation of Cigarettes

Source: The Los Angeles Times

The U.S. Food and Drug Administration barely had time to start regulating cigarettes before legislation was introduced to weaken its authority.

The Family Smoking Prevention and Tobacco Control Act was passed in 2009 with sweeping majorities in both houses; its primary goal was to reduce the terrible toll that smoking takes on Americans’ health, especially by discouraging young people from taking up the habit. The law gave the FDA the authority to regulate the advertising and packaging of cigarettes, along with ingredients such as nicotine and flavorings that affect how easily the public is drawn into smoking and how addictive the habit is once started. As required in the law, for example, the FDA banned candy flavorings in cigarettes, which make the product more appealing to underage smokers and young adults.

But now that the agency is taking meaningful steps against smoking, Rep. Denny Rehberg (R-Montana) has added an amendment to the agriculture appropriations bill that would restrict the FDA’s authority over cigarettes and a host of other matters. Currently, the FDA is considering whether to ban one of the most popular and profitable ingredients — menthol — but Rehberg’s amendment would keep it from taking that action. No longer would the FDA be able to consider a substance’s tendency to attract smokers or make cigarettes more addictive. Rather, the FDA could only ban or limit ingredients that are found to make the cigarette physically more harmful than existing products. Menthol has not been found to do that; it does its damage by drawing people into smoking and keeping them there. Menthol masks the flavor and irritation of cigarette smoke; menthol cigarettes are perceived by consumers as “light” or less dangerous, though they aren’t. Studies have found that menthol makes it easier for young smokers to get started and harder for habitual smokers to stop. Unlike restrictions on fruit flavors, a ban on menthol could dramatically affect smoking rates — one-fourth of smokers prefer menthol brands — which is exactly why the tobacco industry is fighting any such restrictions.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Philip Morris Int’l purchases license to nicotine system

Source: Associated Press

Cigarette maker Philip Morris International Inc. has purchased the rights to a technology that lets users inhale nicotine without smoking.

The world’s largest nongovernmental cigarette seller told The Associated Press on Thursday it has bought the patent for an aerosol nicotine-delivery system developed by Jed Rose, director of the Center for Nicotine and Smoking Cessation Research at Duke University in Durham, N.C. The school does not have a role in Rose’s agreement with the company and won’t receive any money. Terms were not disclosed.

“By avoiding the burning process altogether, finding a way of giving smokers nicotine to inhale but without those toxic substances that we can reduce the death and disease associated with smoking,” said Rose, who led the initial studies in the early 1980s that helped pave the way for commercial nicotine patches as a smoking cessation treatment.

“Hopefully it’s a wave of the future that inhaling combusted, burning tobacco will someday be a thing of the past.”

Rose said the next step is for Philip Morris International, with offices in New York and Lausanne, Switzerland, to develop a commercial product using the technology. The system differs from current medicinal nicotine inhalers available on the market as stop-smoking aids because it delivers nicotine more rapidly to mimic the nicotine “hit” a cigarette provides smokers.

“The other methods of delivering nicotine fall short of providing smokers with the satisfaction that they crave,” Rose said.

The move is an “important step in our efforts to develop products that have the potential to reduce the risk of smoking-related diseases,” Doug Dean, Philip Morris International’s senior vice president for research and development, said in a statement.

Spokesman Peter Nixon said it may take three to five years to develop a commercial product that would be considered an alternative to conventional cigarettes.

Its shares rose 93 cents, or more than 1 percent, to $70.42 in afternoon trading.

Thursday’s announcement is the latest in a series of steps by tobacco companies to venture into smokeless tobacco and other nicotine products as tax increases, health concerns, smoking bans and stigma cut into demand for cigarettes.

Last month, British American Tobacco PLC created a subsidiary called Nicoventures focused on nicotine alternatives. In 2009, the nation’s second-largest tobacco company Reynolds American Inc. purchased Swedish company Niconovum whose nicotine gum, pouches and spray help people stop smoking.

“We know that people smoke for the nicotine and die from the smoke,” said David Sweanor, a Canadian law professor and tobacco expert who consults with companies and others on industry issues. The question becomes, “can you give them the nicotine without the smoke in some way that’s consumer acceptable.”

The U.S. Food and Drug Administration is developing guidelines for companies interested in developing what the agency calls modified-risk tobacco products.

“Changes in the regulatory systems are creating an environment where competitive forces will move this market quite dramatically,” Sweanor said.

Nearly 6 million people die from tobacco use each year, from both direct use and secondhand smoke, according to the World Health Organization.

Philip Morris International, smaller only than state-controlled China National Tobacco Corp., was spun off from Richmond, Va.-based Altria Group Inc. in March 2008. Altria, owner of the nation’s largest tobacco company, Philip Morris USA, still sells Marlboro and other brands in the U.S.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

FDA panel finds ban on menthol cigarettes would ‘benefit the public health’

Author: Lyndsey Layton

An advisory panel to the Food and Drug Administration that has been studying whether the government ought to ban menthol cigarettes said Friday that the “removal of menthol cigarettes from the marketplace would benefit the public health.”

The panel, made up of scientists, doctors and public health experts, stopped short of recommending a ban on menthol cigarettes, which make up about 30 percent of the $80 billion U.S. cigarette market.

The committee, which spent a year analyzing menthol cigarettes before releasing its draft recommendations, said that compared to standard cigarettes, the mint-flavored products do not pose greater individual risk to smokers in terms of lung cancer, stroke and other tobacco-related diseases.

But menthol cigarettes are especially enticing to teenagers and to blacks and are more likely to turn them into lifetime smokers, the panel found. Smokers of menthol cigarettes also find it harder to quit, the panel said.

Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products, said the agency will review the panel’s recommendations. The FDA is not required to follow the advice of its advisory panels but often does. “Now it’s up to us to do our job,” Deyton told the panel.

The menthol question will be the first real test of how aggressively the FDA intends to regulate tobacco. Congress passed landmark legislation in 2009 that put tobacco under the authority of the FDA for the first time. The law prohibits the agency from outlawing tobacco or nicotine but gives it broad authority to regulate the ingredients in cigarettes and the way they are marketed.

Congress banned candy and spice flavorings such as chocolate and clove, saying cigarette makers used those products to hook youngsters into a lifetime addiction. But it exempted menthol from the ban, saying it wanted the FDA to study the issue and report by 2012 whether restrictions on it would serve the public health.

A coalition of anti-smoking groups hailed the panel’s findings.

“The committee’s conclusions leave no doubt that menthol cigarettes have had a profound adverse impact on public health in the United States, resulting in more smoking and more death and disease from tobacco use,” the coalition said. “Now the FDA must act expeditiously and implement the committee’s recommendation.”

Lorillard, whose Newport brand is the best-selling menthol cigarette in the country, dismissed the panel’s conclusions as “unsubstantiated.”

Murray S. Kessler, Lorillard’s chairman, president and chief executive, said in a statement that the report “is just the first step in what we believe will be a very long process that ultimately does not result in the removal of menthol cigarettes from the marketplace, especially when contraband and other unintended consequences are seriously considered.”

The tobacco industry maintains that a menthol ban would expand the black market for cigarettes, encouraging criminal behavior and robbing the government of tax revenue.

The industry also maintains that menthol cigarettes pose no greater harm than regular cigarettes and therefore should not be treated differently.

Lorillard and Reynolds American, which makes Kool brand menthol cigarettes, objected to the panel before it issued recommendations. They filed a lawsuit Feb. 25 charging that the panel cannot provide unbiased recommendations because three members have conflicts of interest. The FDA has declined to comment on the charges.

Menthol cigarettes are used by about 80 percent of black smokers, infusing the debate with questions about race.

The panel found that tobacco companies have advertised menthol brands heavily in black communities and that the targeting has paid off. “The evidence is sufficient to conclude that menthol cigarettes are disproportionately marketed per capita to African Americans” the panel found. “Consistent with these targeted marketing efforts, menthol cigarettes are disproportionately smoked by African American smokers.”

William S. Robinson, executive director of the National African American Tobacco Prevention Network, said when Congress banned flavorings that help addict young smokers, menthol should have been included.

“Why does menthol have to meet a different threshold than all the other ingredients that were already banned,” Robinson said. “Given the people who use the product the most, we felt that continuing to allow menthol was discriminatory.”

Removing menthol cigarettes from the marketplace could avert thousands of deaths each year, the panel said. About 400,000 Americans die annually of tobacco-related disease.

Of the country’s three top tobacco companies, Lorillard has the most at stake in the debate over menthol. About 90 percent of its sales are linked to Newport and other menthol cigarettes.

March, 2011|Oral Cancer News|

Popularity surges for e-cigarettes, but health questions unanswered


A closer look at the battery-powered cigarettes.

Misti Stewart of Gregor’s Eastside Liquor demonstrates an electronic cigarette. They have gained popularity since the smoking ban. / Elisha Page / Argus Leader

Jeff Mann has found a way to get his nicotine fix with no ash, no flame, no odor and no bad breath.

And he can do it legally inside businesses that are smoke free.

Mann, 40, smokes an electronic cigarette. It’s a battery-powered device that looks like a cigarette and emits cigarette-like smoke, but delivers nicotine in vapor form.

“You can get a nicotine level that you’re used to getting from a regular cigarette,” Mann said.

E-cigarettes have been available in the United States since 2006 and have grown in popularity in Sioux Falls since the smoking ban went into effect Nov. 10. They’re sold in bars, casinos and various retail shops. At least one local distributor has seen a 50 percent increase in sales.

But the federal Food and Drug Administration has not approved e-cigarettes. That raises red flags for some health professionals and has them questioning what risks might be associated with e-cigarettes.

Smoker says device helped him cut back

The FDA lost a court case last year after trying to treat e-cigarettes as drug-delivery devices instead of tobacco products because e-cigarettes heat nicotine extracted from tobacco.

But Mann, who owns Vishnu Bunny Tattoo and Piercing, views e-cigarettes as a healthier alternative to the traditional cigarettes he has smoked for 25 years. He said it has helped him cut down on smoking.

Prices range from less than $10 for disposable e-cigarettes to $100 for a kit with a lifetime warranty.

Critics say flavors can entice children

Users can buy cartridges with varying levels of nicotine, all the way down to a cartridge containing no nicotine. They also come in flavors such as chocolate and vanilla, which critics say can tempt children. OCF Because e-cigarettes are not FDA-approved, Dr. Jeffry Meyer of Sanford Health hesitates to tell patients it’s OK to use them.

“We rely on the FDA to research and give good advice,” Meyer said. “We believe they have good reason for coming out against something … there may be some potential harm or abuse potential.”

Deb Murray, a respiratory therapist at Avera Heart Hospital, heard about e-cigarettes a year ago but said patient interest peaked in November.

Murray is concerned about the mystery of what is in e-cigarettes.

E-cigarettes are advertised as a healthy alternative, and companies say they lack the carcinogens found in tobacco products.

“(People are) thinking it is a healthy alternative, but they need to be aware of the unknown nicotine amount, the unknown health effects and that they are not FDA approved,” Murray said. “There may be chemical contents that might affect their health. There are so many unknowns.”

The American Cancer Society also does not endorse or suggest people use e-cigarettes, said Jennifer Stalley, director of government relations for the American Cancer Society in South Dakota.

Sellers find raidly rising market

Kristi Englund, 45, has not smoked a traditional cigarette in three months, and she credits e-cigarettes. After smoking for 30 years, Englund said she’s tried other methods for quitting, but nothing worked.

“This is great. It stops that craving for inhaling, which is my big thing,” she said. “The inhaling is a stress reliever.”

Mike Wehrkamp, owner of M & M Distributing, has seen a 50 percent increase in sales of Fifty-One electronic cigarettes since the smoking ban went into effect Nov. 10. He distributes e-cigarettes to about 12 Sioux Falls retailers, and 25 retailers statewide.

He started distributing Fifty-One electronic cigarettes in May 2009.

“I thought it was a great opportunity,” Wehrkamp said. “When I first got into them, I figured, if this ain’t the wave of the future …”

Gregor’s Eastside Liquor has seen a 30 percent increase in Fifty-One electronic cigarette sales the smoking ban, owner Greg Stahl said.

A Fifty-One electronic cigarette kit sells for $100, and comes with two lifetime warrantied batteries, a cell phone-like wall charger and two cartridges, which are screwed onto the batteries.

The refill packs cost $20, and come with five cartridges, which Wehrkamp said is equivalent to a $50 carton of cigarettes.

“These are like your cell phone. You recharge them, they go forever,” Wehrkamp said.

Still, for longtime smoker Kay Johnson, 49, an e-cigarette is not the same as a traditional cigarette.

“The e-cigarette doesn’t give me the same effect. It helps abate the sensation, but it’s not the same,” she said. “It helps to quench your thirst, but that’s it, and not for long.”

February, 2011|Oral Cancer News|

Does chocolate hold the key to cure HPV?

Source: Yahoo News

Indulgent chocolate treats may be the best-known and most widely appreciated product of the cacao tree, but new scientific research from New York Based Cacao Biotechnologies is uncovering potential new applications for the antioxidant-rich beans which could spur an innovative approach to treating human papillomavirus (HPV), a precursor to cervical cancer.

The human papillomavirus is the most common sexually transmitted infection (STI) in the United States, with an estimated 24 million active cases and 5.5 million new cases each year, according to the National Cancer Institute. HPV is the leading cause of cervical cancer in woman with more than 12,000 cases reported in the U.S. each year.

HPV vaccines approved by the Food and Drug Administration are available, but they are not a cure and they can’t effectively prevent all strains of HPV infection in those who are sexually active. Existing vaccines are only proven effective against a small number of high-risk, cancer-causing HPV strains and are not free of serious side effects including convulsions and paralysis. While condoms can reduce the risk of HPV infection, the virus can still be transmitted simply through skin contact of areas not covered by the condom. Vaccination will not cure someone who is already infected with the virus, so even with massive public health education campaigns, HPV will not soon be eradicated because it is so widely spread in the adult population.

According to Penny Hitchcock, Chief of the Sexually Transmitted Diseases Branch of the U.S. government’s National Division of Microbiology and Infectious Diseases, further research on topical microbicides and effective vaccines is critical.

Theobroma Cacao is the scientific name for the tree that bears fruit whose seeds are fermented and ground to produce the worlds favorite sweet: chocolate. Theobroma Cacao translates from the Latin as “Food of the Gods.” Brooklyn-based startup Cacao Biotechnologies was formed to develop innovative pharmaceuticals from Theobroma Cacao seeds, which are arguably the most chemically complex food known; over 4000 different alkaloids (and other active molecules) have already been identified in the seeds with at least as many yet to be.

From the end of World War I through the second World War the standard treatment for serious burns was to apply a tannin solution to the affected area. The solution would crust over the wound and the powerful antioxidant properties of the tannins would aid healing. Around the end of WWII doctors began to notice that some burn patients suffered kidney and liver failure and attributed it to the tannin treatment. By the time of the Korean War silver sulfadiazine, a sulfa drug ointment, replaced tannin solutions and to this day silver sulfadiazine remains the standard burn treatment used in all hospitals. In 2003, researchers in the Netherlands discovered that the supposedly pure tannin solutions used for burn treatment in the earlier part of this century were in fact crude extracts from tree bark which contained compounds other than the base tannins and these compounds were the cause of renal toxicity. Other doctors have since shown that liver failure in burn patients can be caused by changes in blood chemistry from the burn itself. (Multiple organ failure can still happen in severely burned patients today, but today’s level of intensive care and monitoring has greatly reduced this possibility.)

As a result of these new discoveries, several groups of scientists are actively investigating highly purified tannins as alternatives to sulfa drugs. Related, but much more potent compounds, epicatechin oligomers,have been purified from cacao seeds by Cacao Biotechnologies researchers for use in the treatment of burns.

Building on the work of Cacao Biotechnologies’ co-founders Drs. Mark Guiltinan and Siela Maximova of Penn State University (who were team leaders for the international effort which sequenced the cacao genome, as published in Nature (see reference)), scientists Dr. Randall Murphy and Daniel Preston of Cacao Biotechnologies developed a suite of epicatechin-based super antioxidant compounds from cacao that are more than 200 times more potent than red wine and 1000 times more potent than green tea. Based on the shape and an analysis of their molecules they theorized that some epicatechin oligomers should also have strong antiviral properties. Testing proved their theory: they had developed a antiviral compound specifically powerful against HPV.

Because epicatechin oligomers are related to tannin, they are an effective burn treatment and so can be used to treat genital warts caused by HPV. (The current treatment for HPV genital warts is to burn them off using electro-cauterization, acid, or a laser. The post treatment regimen for healing the genital burn is topical silver sulfadiazine ointment, which is an antibacterial but not an antiviral.) Silver sulfadiazine does little to prevent the treated area from being reinfected or to help suppress or kill any part of the infection not eradicated by the burn treatment. However, Cacao Biotechnologies’ epicatechin-based compound is both antibacterial and antiviral and may prove to be much more effective in post-operative treatment of the removal of HPV genital warts.

The Chinese Cancer Institute (Hospital), & the Chinese Academy of Medical Sciences have developed a patented HPV cure based on tea epicatechins although the treatment has not been shown to work in all patients. OCF. This may be due to the weak efficacy of the epicatechin compounds that can be derived from tea. Cacao-based epicatechins are hundreds of times more potent.

New drug trials often take many years and cost hundreds of millions of dollars in order to obtain FDA approval. However, because Cacao Biotechnologies’ molecules are natural products derived from foods that are generally recognized as safe (GRAS), clinical trials can be carried out much more quickly and inexpensively. Cacao Biotechnologies is applying to the Food and Drug Administration and its European equivalent and expects to start Phase 1 clinical trials within the next six to nine months.

Newly Published Data in Nature Genetics Details Sequencing of Chocolate Genome
Researchers from Penn State University and the French agricultural research and development organization CIRAD have sequenced the complete genome of a Criollo strain of Theobroma Cacao and recently published the research in the journal Nature Genetics. Dr Mark Guiltinan, research team leader at Penn State, has already identified hundreds of genes potentially involved in pathogen resistance and even health benefits, all of which can be used to accelerate the development of, and insure the future thriving of elite varieties of cacao. Cacao Biotechnologies is a major funder and partner of the Cacao research program at Penn State University.

February, 2011|Oral Cancer News|

Ban flavored tobacco products

Author: staff

On 1/5/11, the Assembly introduced legislation banning the sale of flavored tobacco products. The American Cancer Society continues to be a strong advocate of this effort. Below is our memo of support:

Memorandum In Support A. 288
An Act to amend the public health law, in relation to prohibiting the sale of flavored tobacco products.

This measure prohibits the sale in New York of tobacco products, other than cigarettes, containing natural or artificial additives that impart to a tobacco product or its smoke flavors attractive to youth including, but not limited to, fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice flavoring. Menthol, mint and wintergreen flavors are excepted. In no event shall a tobacco product be construed as flavored based solely on the use of additives or flavorings in its manufacture, or their presence on an ingredient list.

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act granting the federal Food and Drug Administration authority to regulate tobacco products and banning the use of flavors other than menthol in cigarettes. However, other tobacco products, including “little cigars” (cigarettes wrapped in paper containing tobacco), cigars, snuff and other smokeless tobacco products were not included in the prohibition. This bill corrects that oversight.

An important function of the flavorings affected by this legislation is to mask from tobacco product users, particularly new users, the harsh, toxic properties of tobacco smoke and spit tobacco. Tobacco industry internal documents uncovered during the course of litigation show that manufacturers have long regarded flavored merchandise as “starter” products from which teenage experimenters will “graduate” to adult brands.

One company memorandum depicts US Smokeless Tobacco’s “graduation strategy” in a chart prepared by the company’s marketing department. The plan is to begin users with flavored Skoal and Happy Days brand products, and gradually promote them to the full-nicotine, tobacco flavored Copenhagen brand. The memorandum describes:

“Three products of three different tastes and strengths of nicotine: a) High nicotine, strong tobacco flavor…b) Medium strength of nicotine…using a Happy Days product [Happy Days comes in three flavors “natural,” “sweet” and “mint”]… c)Low nicotine, sweet product [Skoal]…Do we flavor this product with honey, chocolate or vanilla?”

In addition to mint, UST’s Skoal brand today is sold in peach, cherry, apple, vanilla and berry flavors. UST’s marketing campaign has been tremendously successful. From 1970, when it began, to 1991, the prevalence of snuff use among adult males more than doubled, and among males 18 to 24, it increased more than six-fold. By 1990, more than one in four white male high school students in the U.S. used smokeless tobacco.

If anything, cigars, especially “little cigars,” provide even more egregious examples of this marketing strategy. Swisher Sweets come in cherry, strawberry, peach and grape flavors. Captain Black little cigars are sold in “Peach Rum,” “Tahitian Cherry,” and “Madagascar Vanilla” varieties. And then there’s HBI International, which produces wrappers in more than 30 flavors including Milk Chocolate, Absinthe, Tequila, Peaches & Cream, Mango, Bubblegum and Chocolate Chip Cookie Dough.

This legislation would ban about 25 percent of cigars and less than 20 percent of moist smokeless tobacco currently sold.

Despite the federal ban on flavored cigarettes, flavored cigars and smokeless tobacco products continue to inappropriately attract new young, users. This bill is a much-needed step to protect our children and to reduce their risk of nicotine addiction and the subsequent lethal effects of tobacco.

The American Cancer Society strongly supports enactment of this legislation.

January, 2011|Oral Cancer News|

Tobacco manufacturers must report ingredients to FDA

Author: Richard Craver

The Food and Drug Administration is giving tobacco manufacturers less than three months to provide proof that any product introduced since February 2007 is “substantially equivalent” to products already in the marketplace.

If a manufacturer does not file a report by March 22, or cannot substantiate its evidence, the FDA said Wednesday that it could remove the product from store shelves.

The announcement updated the guidance provided to manufacturers in June 2009 as part of enacting the Family Smoking Prevention and Tobacco Control Act.

Manufacturers of any product introduced after March 22 must submit an application and obtain a marketing order from the FDA before placing the product on the market.

The emphasis of the new rules puts R.J. Reynolds Tobacco Co. in the bull’s-eye because it has been the most prolific developer of tobacco products in recent years, including Camel Snus and the Camel orbs, sticks and filmlike strips for the tongue.

“No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such,” said Dr. Lawrence Deyton, the director of the FDA’s Center for Tobacco Products.

“These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products.”

The FDA defined “substantially equivalent” as “being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single-predicate product or have different characteristics, but not raise different questions of public health.”

Manufacturers that submit evidence will be allowed to continue to market their products “unless the FDA issues an order finding the product to be not substantially equivalent” to the product already in the marketplace.

Bill Godshall, the executive director of SmokeFree Pennsylvania, said he would not be surprised if the FDA uses the substantially-equivalent requirement “to try to ban many or most new tobacco products, especially the least hazardous ones.”

“The FDA could claim that substantially equivalent means virtually identical, and/or that a slightly different color, shape, size or even a 5 percent difference in any constituent means the products aren’t substantially equivalent,’ Godshall said.

The new rules likely cover the dissolvable Camel products that Reynolds placed in test markets in January 2009. Reynolds recently said it is reconfiguring the test markets.

Maura Payne, a spokeswoman for Reynolds, said in June 2009 that the products are substantially equivalent to dissolvables sold by Star Scientific Inc.’s Ariva and Stonewall.

It is not clear whether the rules apply to Camel Snus. Reynolds began test markets for Camel Snus in June 2006 before taking it national in January 2009.

Analysts said that any substantial changes to Camel Snus, including potentially new or altered flavoring, could make it susceptible to the new rules.

Dr. John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said that the FDA has clarified its guidance with the update.

“For example, now the FDA states that a new public-health question is whether use of the new product induces nonsmokers to start smoking,” Spangler said. “This could pose a roadblock to the introduction of new products if the FDA abides by this strict standard.”

Both Reynolds and Altria Group Inc., which owns Philip Morris USA, said they are reviewing the FDA guidance.

“We have submitted several applications on substantial equivalence to the FDA, and we look forward to working together with the FDA on the applications we have submitted, as well as the development of the guidance and proposed rulemaking on exemptions to the substantial-equivalence process,” said David Howard, a Reynolds spokesman.

In April, Reynolds complied with an FDA request for information about its dissolvable products.

Deyton wrote in a letter to Reynolds that the Center for Tobacco Products was concerned that “brightly colored” packaging and the “candylike appearance” of the products may appeal to children, as well as “facilitate initiation of tobacco use, nicotine dependence and addiction in adolescents.”

Stephen Pope, an industry analyst and the managing partner of Spotlight Ideas in England, said manufacturers face a steep hurdle in trying to get past the FDA requirement that a new product doesn’t compel a non-tobacco consumer into use.

“Thinking of tobacco use, of course, the main thrust is that if a product claims to provide all the taste, flavor and enjoyment of a previously available product — with the benefit of a reduced risk — then it may entice more new smokers than would otherwise have been the case,” Pope said.

“In my view, the FDA wants to reopen the test books, just to be sure that all that should have been done has been done, and done with vim and rigor.”

January, 2011|Oral Cancer News|

New snuff low in carcinogens, Virginia company says

Author: Richard Craver

A small tobacco manufacturer in Richmond, Va., said Tuesday that it has developed a moist-snuff product that has the lowest levels of carcinogens — in this case nitrosamines — in the marketplace.

That includes “99 percent lower than the levels found in conventional American moist snuffs, such as Copenhagen or Skoal, and 90 percent less than the level found in current snus products,” the company said.

Star Scientific Inc. plans to apply soon to the Food and Drug Administration for permission to market the product, part of its Stonewall brand, as “modified risk” under the Family Smoking Prevention and Tobacco Control Act of 2009. That act gave the FDA the regulatory control over new tobacco products.

Star applied last year to market its Ariva and Stonewell lozenges as modified risk.

“Our company’s belief and hope is that the FDA will give a robust look at the science of our application and other reduced-risk applications,” said Sara Machir, the vice president of communications and investor relations for Star.

The request is likely to stoke further debate between two sets of anti-smoking groups.

One set says smokeless tobacco serves as gateway products for teenagers to cigarettes and discourages users from quitting. The other set says the products are a way to reduce the risk of tobacco use compared with cigarettes.

Scott Ballin, the past chairman of the Coalition on Smoking or Health, said the debate “is more about competition, market share and profits than it is about public health.”

If Star’s moist-snuff claim can be verified, it is likely to get through the FDA approval “in a quicker-than-usual time period,” said Stephen Pope, an industry analyst and the managing partner of Spotlight Ideas in England.

“Given the fast-growth rate of the smokeless tobacco market … surely it is better to speed the analysis and verification of this product so that a ‘healthy option’ is made available to the public ASAP.”

If Star makes a product the FDA approves and consumers like, it likely would require being bought by a larger manufacturer “to even think of getting this product on the market years from now,” said Jeff Middleswart, the portfolio manager of USA Mutuals Vice Fund.

January, 2011|Oral Cancer News|

RJ Reynolds’ ads urge tobacco pouches for smokers

Author: Emery P. Dalesio

R.J. Reynolds Tobacco Co. is targeting people who resolve to quit smoking in the new year with advertisements suggesting they switch to its smokeless tobacco pouches, a move critics say is an attempt to keep people from quitting nicotine.

The ads mark the company’s first campaign aimed at getting smokers to switch to the pouches known as snus, which Reynolds introduced in early 2009, spokesman David Howard said Wednesday.

The carefully worded ads suggest, but don’t say directly, that the pouches are a way to help kick the smoking habit. Under federal law, companies cannot claim that tobacco products work as smoking cessation products. But tobacco companies would love for smokers to think of them that way as cigarette sales fall because of higher taxes, smoking bans and falling social acceptability.

The No. 2 U.S. cigarette maker is advertising in major magazines this month its suggestion for a “2011 Smoke-Free Resolution” in some ads that show the tobacco-filled white pouches dropping from the sky like confetti. The ads promote the company’s Camel snus — small pouches filled with tobacco that users stick between the cheek and gum.

“If you’ve decided to quit tobacco use, we support you. But if you’re looking for smoke-free, spit-free, drama-free tobacco pleasure, Camel Snus is your answer. Logon to the Pleasure Switch Challenge and see how simple switching can be. Camel Snus — it might just change the way you enjoy tobacco,” one ad says.

“At this time, there will some that will be considering the option to maybe quit smoking, but not necessarily quit enjoying tobacco pleasure,” Howard said. “We want to inform them that here is a product that is an option for you to consider.”

The “resolution” ads appeared in wide-circulation magazines including Time, Sports Illustrated and People, Howard said. Two other versions, which specifically address themselves to smokers, appeared in alternative weekly newspapers around the country, he said. Those ads feature the packaged product at the heart of snowflakes or ringed into a holiday wreath.

All three ads also warn: “Smokeless tobacco is addictive.”
An anti-tobacco campaigner said the Reynolds ads aim to reorient smokers to smokeless snus to keep them from being lost as potential customers.

“These ads are trying to take advantage of the fact that around the first of every year many people try to quit smoking altogether. These ads aren’t designed to help people quit, they’re designed to keep people using tobacco,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

The Food And Drug Administration, which regulates tobacco advertising, is reviewing the Reynolds ad campaign. The agency is charged under the Tobacco Control Act with deciding if any tobacco ads make false claims.

“The claims made by R.J. Reynolds Tobacco Co.’s advertising and labeling materials are being evaluated by the FDA,” spokesman Jeff Ventura said.

R.J. Reynolds is owned by Reynolds American Inc., based in Winston-Salem, N.C.

About 46 million American adults, or one in five, still smoke and about the same number are former smokers, according to the Centers for Disease Control and Prevention. That’s down from one out of four Americans who smoked in 1995. About 3 percent of American adults use smokeless tobacco.

The CDC says smokeless tobacco contains 28 cancer-causing agents and is not a safe substitute for smoking cigarettes. But a 2007 report from the United Kingdom’s Royal College of Physicians suggests that some smokeless tobacco products are less harmful than cigarettes.

“Since tobacco smoking is driven primarily by addiction to nicotine, but the harm from smoking is caused by other smoke constituents, the rational next-best option is to reduce the harm arising from nicotine use by providing it in a form that does not involve inhaling smoke,” the report said.

January, 2011|Oral Cancer News|

Reynolds targets smokers trying to quit with new snus campaign

Author: staff

R.J. Reynolds Tobacco Co. wants cigarette smokers to consider Snus if they are trying to quit.

According to the Winston-Salem Journal, the giant tobacco company has launched a national campaign marketing Camel Snus as a potential New Year’s Resolution solution for smokers. It’s the company’s first campaign aimed specifically at encouraging smokers to switch to Camel Snus, according to David Howard, a Reynolds spokesman.

“A lot of adults make a decision to quit smoking this time of the year,” said Howard in the report. “For those making that attempt, but still wanting the pleasure of tobacco, we’re saying ‘Here’s an option.”

Reynolds has run ads in large-circulation magazines such as Entertainment Weekly, People, Sports Illustrated, Time and US Weekly, as well as free and alternative publications, according to the report.

In the “2011 smoke-free resolution” ad, Reynolds said it supports smokers who have decided to quit using tobacco. “But if you’re looking for smoke-free, spit-free, drama-free tobacco pleasure, Camel Snus is your answer,” the ad’s text reads.

The ads also contain a large warning that “smokeless tobacco is addictive.”

Howard said that the “drama-free” reference is aimed at adults who want to use tobacco products in restaurants, bars and other social outlets where smoking is discouraged or banned.

Reynolds’ print ads are part of a “take the pleasure switch challenge” campaign tied to an age-restricted Camel Snus Web site.

As might have been expected, some anti-smoking groups are upset by the ads.

“The ads are trying to take advantage of people trying to end all uses of tobacco,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. “If a smoker does that, switch to smokeless, they’ll be worse off than if they had quit.”

Snus comes in a small pouch that is placed between the lip and gum. The tobacco is pasteurized, not fermented, and it contains less moisture and salt than moist snuff. It also does not require the consumer to spit.

Although Reynolds does not dictate the price of Camel Snus at retail, the price is comparable to a premium pack of cigarettes, which typically sells for $4 to $4.50 in North Carolina.

Reynolds began its first trial of Camel Snus in April 2006, with national distribution commencing in January 2009. The ads do not make any claims of reduced health risks with a potential switch.

Some anti-smoking advocates are encouraging the U.S. Food and Drug Administration to allow the advertising of smokeless tobacco as less harmful than cigarettes if such claims can be proven through research. But other anti-tobacco advocates oppose marketing smokeless products under cigarettes’ brand names because of those brands’ appeal to youth, according to the Winston-Salem Journal report.

December, 2010|Oral Cancer News|