Tobacco.org

FDA Exercises New Authority to Regulate Tobacco Products, But Some Limits Remain ($$) 

With great fanfare, the US Food and Drug Administration (FDA) on September 22 announced a ban on certain flavored cigarettes that, the agency says, are aimed at enticing children to smoke.

"Almost 90% of adult smokers start smoking as teenagers, and these flavored cigarettes are a gateway for many children and young adults to become regular smokers," said FDA Commissioner Margaret Hamburg, MD, at a press conference announcing the ban.

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FDAImports.com Reports: FDA Bans Flavored Cigarettes While U.S. Opposes Canadian Ban on Flavored Cigarettes at WTO 

FDAImports.com reports: the U.S. government is a house divided. While some government officials are fighting for greater restrictions on the sale of tobacco products, others are fighting to prevent any more restrictions and balking at the restrictions that other nations have implemented on tobacco sales. Does the right hand know what the left hand is doing?

On November 6, FDA posted a special update on its web site, highlighting what its Center for Tobacco Products has done to implement the Family Smoking Prevention and Tobacco Control Act. On the list was the statutory ban on cigarettes containing certain characterizing flavors (other than menthol) that went into effect on September 22, 2009. FDA stated that it is also exploring options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes, in efforts to reduce smoking in America; particularly youth smoking. FDA also established mechanisms for the public to report information about possible violations of the law, and has issued Warning Letters to firms who appear to be in violation of the ban.

Meanwhile, at a World Trade Organization meeting last week, U.S. members joined Mexico and 5 other countries in the Committee on Technical Barriers to Trade in opposing Canada's ban on flavored tobacco products. These members voiced concerns that the ban was too restrictive, since it bans all tobacco products with even one of the listed additives, and that it would impact various countries' exports. U.S. Senator Jim Benning (R-KY) is using political means to pressure President Obama to fight the Canadian law -- by placing a hold on the nomination of Miriam Shapiro to be deputy trade representative.

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FDA Bans Flavored Cigarettes While U.S. Opposes Canadian Ban on Flavored Cigarettes at WTO 

FDAImports.com reports: the U.S. government is a house divided. While some government officials are fighting for greater restrictions on the sale of tobacco products, others are fighting to prevent any more restrictions and balking at the restrictions that other nations have implemented on tobacco sales. Does the right hand know what the left hand is doing?

On November 6, FDA posted a special update on its web site, highlighting what its Center for Tobacco Products has done to implement the Family Smoking Prevention and Tobacco Control Act. On the list was the statutory ban on cigarettes containing certain characterizing flavors (other than menthol) that went into effect on September 22, 2009. FDA stated that it is also exploring options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes, in efforts to reduce smoking in America; particularly youth smoking. FDA also established mechanisms for the public to report information about possible violations of the law, and has issued Warning Letters to firms who appear to be in violation of the ban.

Meanwhile, at a World Trade Organization meeting last week, U.S. members joined Mexico and 5 other countries in the Committee on Technical Barriers to Trade in opposing Canada's ban on flavored tobacco products. These members voiced concerns that the ban was too restrictive, since it bans all tobacco products with even one of the listed additives, and that it would impact various countries' exports. U.S. Senator Jim Benning (R-KY) is using political means to pressure President Obama to fight the Canadian law -- by placing a hold on the nomination of Miriam Shapiro to be deputy trade representative.

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• Physicians Urge FDA to Justify Condemnation of E-Cigarettes 

"We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes," says Joel L. Nitzkin, Chair of the American Association of Public Health Physicians Tobacco Control Task Force in a letter to the FDA.

The letter specifically targets the new tobacco legislation that passed through Congress this summer which gives the FDA power to regulate tobacco products in the United States and notes that the success rate of current smokers who attempt to quit by using pharmaceutical aids is as low as 5%. Making smokers more aware of less harmful alternatives, snus and e-cigarettes included, could significantly reduce the amount of smokers who die due to tobacco-related illnesses.

"Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products," says the letter. The FDA's study in July found miniscule amounts of carcinogens in a few e-cigarette cartridges, but failed to provide any data on the amount of those same carcinogens in pharmaceutical nicotine products.

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• AP IMPACT: Tobacco execs quickly find tax loophole 

With a simple marketing twist, tobacco companies are avoiding hundreds of millions of dollars a year in taxes by exploiting a loophole in President Barack Obama's child health law.

Obama and Congress increased taxes on tobacco products earlier this year to pay for expanded children's health insurance, but tobacco for roll-your-own cigarettes saw a disproportionate leap, from $1.10 to $24.78 per pound. Some predicted the tax would kill the roll-your-own industry, which had offered a cheaper alternative to packaged cigarettes.

But tobacco companies quickly adapted. The Associated Press found that as soon as the tax was on the books, companies all but shut down their roll-your-own brands and reinvented them under a less-restricted, less-taxed category: pipe tobacco. It's still destined to be rolled and smoked, but it's taxed at barely a tenth the rate, $2.83 per pound.

Normally, pipe tobacco is coarser and moister than cigarette tobacco. But nothing says it has to be. In fact, the federal government says the only distinction between the two is how it's labeled. That effectively gives tobacco marketing executives an opportunity to shape the company's tax rate. . . .

Anti-tobacco groups say it's deception, and not just because of the taxes. While flavored cigarettes are now banned in an effort to reduce the appeal of smoking to children, no such ban applies to pipe tobacco, allowing companies to sell black cherry, vanilla and other varieties. "This is a direct challenge to the federal government," said Matthew Myers, president of the Campaign for Tobacco Free Kids.

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BOGUS BAN? Opponents take unprecedented approach to restore smoking 

Groups opposing the state smoking ban have taken the fight up a notch, citing evidence of ballot fraud -- more than three years after voters approved the ban.

Opponents of Ohio Bans said the petition that placed the smoking ban on the 2006 statewide ballot was tainted by numerous irregularities, such as 46 convicted felons gathering signatures. The group claims the petitions should have never been certified.

Nearly 59 percent of voters approved the ban in 2006. The ban prohibits smoking in most public places in Ohio, including bars and restaurants.

According to an Ohio News Network report, members of Buckeye Liquor Permit Holders Association want the U.S. Department of Justice to investigate the fraud claims. They want family-owned businesses and private clubs exempted from the ban.

Under ban rules, "private residences; family-owned businesses without non-family employees; certain areas of nursing homes; outdoor patios; and some retail tobacco stores are exempt."

Association officials also are threatening a class action lawsuit for the hundreds of bars they claim went out of business because of the ban.

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Resources For Industry 

Chapter IX of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires industry submission of certain information.

Establishment Registration and Product Listing Under section 905 of the act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.

* Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

* The FDA’s eSubmitter tool is designed to facilitate efficient and secure electronic submission of this information and provides automatic acknowledgement of FDA receipt with attached data from FDA to facilitate future submissions. Instructions and helpdesk assistance (esubmitter@fda.hhs.gov or 1-877-FDA-1CTP (1-877-332-1287)) are available. The instructions also address information regarding obtaining a DUNS number.

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BELANGER: Race to Extinction 

Imagine for a moment, your stores' back bars and tobacco sections as they are today. Now remove all flavored SKUs -- the Black & Mild Wine and Cream cigars, the grape and peach Swisher Sweets, the coffee little cigars and the wintergreen moist snuff. How much revenue would you lose if this were to happen, not even counting the ancillary purchases that come with these items? And for a moment, remove menthol items from the racks as well. The tobacco category becomes barren.

Ask yourself this -- can the stores survive without these products, and the traffic and sales they bring in? Unless the stores have a stellar foodservice offer, the answer is most likely no.

If the convenience industry allows the FDA to push its limits on a recently enacted law, it may be the end of the important category -- at least as we know it today. . . .

The fate of all the flavored tobacco items in your stores is in your hands. Help the efforts of NACS, NATO, and other tobacco groups and manufacturers. Help elect lawmakers who stand for free enterprise and against the nanny-state. Inform your customers of impending legislation and its impact. It is imperative the industry does not let the FDA put a chokehold on the tobacco category in convenience stores.

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Crackdown becomes a drag for clove smokers  

The band of clove smokers is small in South Florida. But as their cloves diminished, stick by stick, worries flared about how this new ban would affect the local culture in a place where partyers can still puff at nightclubs, in a state that has chosen not to levy taxes on tobacco.

``What Hollywood is to actors, Miami is to cigars,'' said William Carroll, manager at Vilar Cigar Shop in South Miami. ``We wonder if its cloves first, then what's next?''

Vilar Cigar smells like roasted coffee and boasts more than 200 types of tobacco. Less than 1 percent of buyers wanted cloves, Carroll said, so it made little difference profit-wise. The shop easily gave them up but remains wary about the future.

Signed in June, the Family Smoking Prevention and Tobacco Act gave retailers, manufacturers, and distributors three months to get rid of their flavored cigarettes -- or face warning letters, fines or prosecution.

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American Lung Association Urges Full Coverage of Clinically Proven Smoking 

As the debate over health care reform dominates the media and political arena, a new American Lung Association report finds that states aren't doing enough to help smokers quit - and policymakers must fix this in the health care reform process. In its new report, Helping Smokers Quit: State Cessation Coverage 2009, the American Lung Association advocates for a national prevention and wellness strategy that targets reducing tobacco use by helping smokers quit and preventing them from starting. Key among these strategies is the full coverage of clinically proven smoking cessation treatments for all smokers.

The Helping Smokers Quit: State Cessation Coverage 2009 report provides an overview of smoking cessation services and treatments offered in each state by public and private health care plans. Currently, only six states provide comprehensive smoking cessation coverage for Medicaid recipients. Only five states even provide such coverage to state employees.

"Helping smokers across the country quit must be an integral part of any reformed health care system," said American Lung Association President and CEO Charles D. Connor. "Policy makers at the federal and state levels have a responsibility right now to ensure that the nearly 46 million smokers in this country have the help they need to quit." . . .

The American Lung Association calls upon each state to provide all Medicaid recipients, state employees and private insurance holders with comprehensive, easily-accessible tobacco cessation medications and counseling.

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• E-Cigarettes Under Fire  

As more cities ban smoking in restaurants and bars, there is a newer product to the United States that makers claim you can still smoke indoors. It's under fire from cities across the country, the Food and Drug Administration and a metro parent.

If you've been to the mall lately, you may have seen a kiosk selling electronic cigarettes. We've found the kiosks at Independence Center and Oak Park mall.

If you walk past the kiosk at Oak Park, a salesperson will ask if you smoke.

At Smoke51 we were shown a product that closely resembled a real cigarette. It comes with a battery and filter and even comes in flavors.

"There's a heating element that steams water, nicotine, and flavor so you're going to see me blow out smoke but it's actually steam or water vapor," the salesman said.

There are many questions about how this product is marketed.

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• Tobacco czar maps new agency's path 

Today Dr. Lawrence Deyton, who at 57 still goes by his childhood nickname of "Bopper," is the nation's first anti-smoking czar. He directs a new agency in the federal Food and Drug Administration -- the Center for Tobacco Products -- that is writing rules to govern the previously unregulated tobacco industry.

In last week's interview, Deyton twice stressed that he is not an anti-tobacco zealot.

"I am not an expert in tobacco," he said. "But I am an expert in public health, and I am an expert in government health programs."

And what Deyton promises is "methodical, science-based tobacco regulation."

But Deyton already has been greeted with worry from growers in tobacco-producing states like Kentucky, and three lawsuits from the industry challenging the agency's authority to restrict advertising and marketing.

The center was created under a sweeping anti-smoking law passed by Congress and signed into law by President Barack Obama on June 22.

Its three key goals are to reduce youth smoking rates, which in recent years have leveled off at about 20 percent; to reduce the overall toll of tobacco-related disease, which annually kills more than 400,000 Americans; and to provide the public with information about the ingredients of tobacco products and their health effects.

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• Insurance discounts for healthy habits spur debate in Washington 

Who could object to rewarding people who quit smoking, lose weight or start to exercise? The American Cancer Society and the American Heart Assn., for starters.

Some companies are charging lower insurance premiums to workers who meet benchmarks for healthy living. The Senate's healthcare overhaul legislation would expand the trend.

But instead of cheering the proposal, some patient advocacy and health groups are worried that it could mean higher rates for less-fit Americans, possibly pricing them out of their employers' insurance plans.

"It is a way of cherry-picking," said Dick Woodruff, senior director of federal affairs for the American Cancer Society. "We are all for workplace wellness, but when you tie it to the insurance pricing system, it's a real problem."

Critics of the Senate proposal also say that giving special treatment to those who meet a company's fitness standards could undercut one of the marquee promises of the Democrats' proposed overhaul: preventing employers and insurers from discriminating against people on the basis of their health status and preexisting medical conditions. . . .

Opponents hope to water down the Senate provision in the legislative maneuvering ahead. A coalition of patient-advocacy and health groups said in a letter to Congress: "We believe that provisions increasing premium variations allowed under current law can -- if used unwisely -- be a back door to making coverage to the sick unaffordable."

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Medicaid access to smoking cessation falls short 

Adapted from Medscape Medical News—a professional news service of WebMD

Berkeley, CA - A national survey shows that although the majority of state Medicaid programs offer coverage for some form of tobacco-dependence treatment, most fall far short of a stated mandate to provide unrestricted access to approved therapies [1].

The report, with first author Dr Sara B McMenamin (University of California, Berkeley) is published in the November 6, 2009 issue of Morbidity and Mortality Weekly Report.

It reveals that only six states cover all of the effective pharmacotherapies and individual and group counseling and only two states reported access to tobacco-dependence treatments without any limitations or restrictions.

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• N.C. court rules against tobacco payments 

Maryland tobacco farmers won't receive about $13 million in payments from cigarette manufacturers under a ruling Friday from the North Carolina Supreme Court.

Officials with the Maryland Department of Agriculture said the state had sought to require that Philip Morris, R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co. honor an agreement to compensate farmers for the declining sales of tobacco expected from a settlement between the tobacco industry and states over the health care costs of smoking.

"Our farmers have been done a big injustice," said Patrick McMillan, assistant agriculture secretary. "The source of income they were led to believe they were going to get has been taken away from them."

The case stemmed from a disagreement over whether the manufacturers were obligated to continue paying farmers under that agreement after Congress approved in 2004 a $10 billion buyout for tobacco farmers nationally, to be financed by taxing the cigarette industry.

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