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"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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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.
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.
The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.
The warning letters directed the companies to cease the marketing and sale of these products immediately or to take other appropriate action to bring the products into compliance with the law. Failure to do so may result in additional regulatory actions such as seizure or injunction. In addition, FDA requested a written response from each of the companies within 15 days outlining the corrective actions taken.
Enforcement of the flavored cigarette ban is FDA’s effort to remove cigarettes that contain certain candy or fruit flavors from the marketplace. Removal of these products from the market will assist in the prevention of children and adolescents from starting to smoke and in the reduction in death and disease caused by smoking.
“FDA takes the enforcement of this flavored cigarette ban seriously,” said Lawrence R. Deyton, M.S.P.H, M.D., director of FDA’s Center for Tobacco Products. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.” . . .
Report possible violations of the flavored cigarette ban: www.fda.gov/flavoredtobacco
The Food and Drug Administration said Friday that it has warned several companies to stop selling banned flavored cigarettes to U.S. consumers online.
The agency sent letters this week to more than a dozen Web-based companies saying they are violating a new ban and asking the companies to describe in writing what action they have taken to comply.
The FDA banned candy-, fruit- and clove-flavored cigarettes in September. Federal health authorities and regulators say those products appeal especially to young people and are thought to attract new smokers.
"FDA takes the enforcement of this flavored cigarette ban seriously," Dr. Lawrence R. Deyton, director of FDA's Center for Tobacco Products, said in a statement. "These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use."
A federal judge ruled Thursday that tobacco companies hoping to block new restrictions on their marketing have little chance of succeeding.
The companies had asked U.S. District Judge Joseph H. McKinley Jr. to issue a preliminary injunction in a lawsuit they filed in August claiming new tobacco regulations violate their right to free speech.
The companies, including two of the industry's three largest, are challenging provisions of a law that gave the U.S. Food and Drug Administration new authority over tobacco. In a 29-page decision, McKinley outlined the arguments in the lawsuit and found that blocking the provisions was not warranted. . . .
The companies say the law, which takes full effect over three years, prohibits them from using "color lettering, trademarks, logos or any other imagery in most advertisements, including virtually all point-of-sale and direct-mail advertisements." Their complaint also says the law prohibits tobacco companies from "making truthful statements about their products in scientific, public policy and political debates."
The tobacco makers say new mandated warnings for cigarettes would relegate their branding to the bottom half of cigarette packaging and make it "difficult, if not impossible, to see."
In its response to the lawsuit, the FDA said the new marketing rules do not restrict free speech and serve a greater public health interest.
The U.S. Food and Drug Administration is moving quickly to use its sweeping new tobacco powers despite facing swift legal action from cigarette makers, the agency's tobacco chief told Reuters on Tuesday.
Dr. Lawrence Deyton said lawsuits from companies such as Reynolds American Inc (RAI.N), Lorillard Inc (LO.N) and others are not slowing his work to set up the FDA's tobacco unit or take action against products that harm the public, especially children.
"Congress is very clear what it wants me to do, I'm moving ahead. Nobody's told me not to," Deyton said in an interview at his office in suburban Maryland.
Burned by the recent US ban on kretek cigarettes, Trade Minister Mari Pangestu said government officials would soon meet with their US counterparts in an effort to alleviate smoldering tension over the issue.
Kretek cigarettes were banned by the US Food and Drug Administration on Sept. 21 on the grounds that their sweet flavor encouraged young people to take up smoking.
“We will arrange a meeting and will be having consultations to seek a fair solution to this matter,” Mari told the Jakarta Globe on Tuesday.
The discussions, Mari said, are a preliminary response, but if no solution is found, then “at the end, it will be taken to the World Trade Organization.”
Mari said previously that the ban was highly detrimental to this country’s clove farmers and was in breach of WTO rules. . . .
Kretek International is apparently not going to take the issue lying down and is now seeking a declaratory ruling from the US District Court in Washington that its cigars are not cigarettes and can therefore be freely sold.
In its petition, it accused the FDA of “deliberately obfuscating” the definition of cigarette,” adding that “If a product is a cigar, it is not a cigarette, and vice versa.”
Wellstone Filters Sciences, Inc. (OTC Bulletin Board: WFSN), the leading modified risk cigarette filter company, is pleased to announce that it participated in the FDA's conference call regarding the guidance document entitled "Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments."
During the conference call, Wellstone's CEO L.J. Hand focused on the need for clarification of registration by companies such as Wellstone who participate in only part of the manufacturing process. Wellstone is a filter technology company dedicated to research, discovery and development of methods and compounds that remove a wide range of toxins and carcinogens without impairing consumer acceptance.
"As marketing restrictions become stronger the pack becomes the best marketing tool," Hammond says. "When the words come off the pack, the industry relies on colors to a greater extent then they used to."
For example, Pall Mall recently removed descriptors like "full flavor" and "light," relying entirely on the color of the pack and the names of colors to identify each flavor.
"Of course, brands have always used colors," Hammond says. "The so called strengths of brands are aligned with the strengths of colors, and many smokers use colors as an indicator of risk. For example, red is perceived to be stronger than blue."
In other words, as the flavors get "lighter," so the do the colors. . . .
"Orange is a very interesting choice," Bansal-Travers says. "No other brand I can think of uses orange as a cigarette pack color, but orange is certainly the lightest that PM uses, creating a spectrum of color and trying to equate that with the spectrum of risk."
Primary design changes: Flavor descriptors, such as "Filter" and "Light," have been dropped, replaced with the names of colors.
Secondary design changes: The phrase "Famous American Cigarettes" has been moved to the bottom. While the logo and Latin phrases "Per aspera ad astra" ("Through hardships to the stars") and "In hoc signo vinces" ("By this sign you shall conquer") remain, the phrases "KING SIZE BOX" and "Wherever particular people congregate" have been removed from the front of the boxes.
For its Salem brand, manufacturer RJ Reynolds has changed the coloring of the packs and the descriptor terms.
the FDA reminded the public that its ban applies to anything that fits a cigarette's profile, even if it's labeled as a "cigar." And the House Committee on Energy and Commerce announced an investigation to find out whether the "flavored cigars are no different than flavored cigarettes."
Immediately, Kretek International Inc., the closely held importer in Moorpark, Calif., sued the FDA, accusing it of "deliberately obfuscating" the "definition of cigarette." . . .
"If a product is a cigar, it is not a cigarette and vice versa," says its complaint. "Kretek contends that Djarum cigars are cigars."
The company has asked the U.S. District Court in Washington for a declaratory cigar-is-a-cigar judgment. The FDA declines comment and has yet to file a response. Without legal guidance, meanwhile, America's clove-conscious now have to judge for themselves whether Djarum's new cigars, deep down, are concealing an alter ego.
At the Indonesian restaurant he owns here in Alexandria, Sonny Setiantoko passed one under his nose. "That smell!" he said.
On a quiet Monday night, he sat at a rear table after a spicy meal of satay and coconut rice.
These items are about to become better known because a federal judge is expected to decide shortly on whether the Food and Drug Administration has authority to regulate them. The devices, which do not contain tobacco, are already being sold around the country.
From the FDA's viewpoint, the e-smokes are "drug delivery" devices, the same as nicotine gum, which is regulated by the agency. The industry association for the product describes it as an "alternative to tobacco," and the association says it would like to work with the FDA. The public-health community is divided, with some wanting to see more research on the items and others seeing them as a way to help people quit tobacco use.
Already, e-cigarettes are entering the public arena. . . .
On e-cigarette websites, former tobacco users offer testimonials about how the new product has saved their lives.
But John Banzhaf, a professor at George Washington University Law School who also heads up an organization called Action on Smoking and Health (ASH), wonders if there is a cardiovascular risk for e-smoke users. And, he adds, "We don't know to what extent kids get hooked."
Enter the FDA.
They have looked at those websites and more. "Some of the product information says you can use the e-cigarettes to help quit smoking," says Siobhan DeLancey, a spokeswoman for the FDA. The agency believes the products should be brought to it for premarket approval, and data should be presented showing the product is safe and effective for its intended use. . . .
In February, one manufacturer, Smoking Everywhere, which is not a member of the ECA, sued the FDA, claiming it did not have jurisdiction. Shortly, federal judge Richard Leon in Washington is expected to rule.
"It will be a seminal moment," says Mr. Banzhaf.
It's a misconception that just because you don't smoke nicotine, it is less addictive and less dangerous than a cigarette.
That's the fallacy and danger behind a marketing ploy for a new take on a centuries old product, snuff.
Whereas the old snuff, popular in the 1970s and 1980s in round paper containers or bags under the name Copenhagen or Skoal, was chewed and spit out, today's snuff comes in fancy containers with equally avant-garde aromas and names. And unlike its predecessor, this snuff isn't pinched into one's gums or chewed, it's inhaled through the nostrils. And it isn't being used just by baseball players or teenage boys emulating their sports idols.
Snuff is being marketed to tweens, teens and college students, both female and male, as hip, cool and healthy. It's available for a nominal cost with a simple click online.
Yet, it's anything but harmless, according to an area ear, nose and throat specialist, who is concerned that in any form, nicotine is extremely addictive. And what makes snuff so dangerous is that it doesn't fall under any federal regulations, according to a local tobacco expert.
Many feel it's the burning and inhaling of tobacco that exposes users to most carcinogens. Some specialists feel that, for health reasons, if you are going to use tobacco, you are better off using nasal snuff. But nasal snuff contains nicotine and is highly addictive, says Dr. Zephron Newmark, an ENT specialist with Geisinger Wyoming Valley Medical Center, Plains Township.
"There is danger for long-term use," said Newmark. "If you become hooked, it can be difficult to stop."
Tony Delonti, a member of the local chapter of the American Lung Association who also serves on the Luzerne County Tobacco Free Coalition, said these latest products are outside the realm of the regular tobacco industry. "It's not a direct tobacco product so it's not regulated by the Food and Drug Administration and it doesn't come under the recent tobacco guidelines passed by the Obama administration," he said. . . .
Just how addictive and seductive is cigarette smoking and a nicotine habit to area youth?
According to a 2007 survey by Steps To A HealthierPA Luzerne County, more than half of the teens surveyed (52 percent) reported trying a cigarette. About 12 percent indicated that they had smoked their first cigarette before the age of 13. About 22 percent smoked during the past month with about 7 percent saying they smoked at school. Approximately 14 percent said they smoked 20 or more days in the past month.
More than half of the respondents (53 percent) also said they had tried to quite the habit during the past year.
Education still remains the most viable tool to get children to pass up on snuff
The U.S. Food and Drug Administration on Thursday will tell a federal judge in Kentucky that ordering the agency to delay enforcing new tobacco laws will have "devastating consequences" on public health.
The FDA is facing a challenge to its new tobacco powers, signed into law in June, from tobacco companies including Camel cigarette maker Reynolds American Inc. (RAI) and Commonwealth Brands Inc. The companies say the law imposes unprecedented restrictions on their First Amendment rights and want a federal court in Bowling Green, Ky., to order a preliminary injunction to stop enforcement of certain provisions in the regulations.
A judge for the District Court for the Western District of Kentucky is holding a hearing on the preliminary injunction request and could soon decide whether to grant the injunction. . . .
"It is crucial to the public health that tobacco products not be marketed as reduced-risk products unless they will, in fact, reduce risks," the FDA said in a brief filed with the court.
The cigarettes in the royal blue package aren't Pall Mall Lights anymore. Now, they're called Pall Mall Blues. Salem Lights, once sheathed in a kelly green box, are now cloaked in pastels and white, and known as Salem Gold Box.
With the new branding, and use of hues shown to evoke feelings of smoothness and health, a leading tobacco company has revealed a subtle sales strategy for an era of unprecedented federal oversight: Let the colors speak to smokers in the same way the soon-to-be-banned words "mild,'' "light,'' and "ultralight'' did.
Harvard researchers and other tobacco control specialists see in the new monikers and lighter, brighter palettes evidence that cigarette producers are intent on subverting a new law that empowers the US Food and Drug Administration to regulate tobacco companies - including a provision that as of next June 22 will banish words that promote certain cigarettes as safer.
Tobacco control specialists have long harbored particular contempt for "mild'' and "light'' cigarettes, arguing they manipulate smokers into thinking those brands are less harmful when there's no scientific evidence to support that claim.
R.J. Reynolds Tobacco Company, maker of the Pall Mall and Salem brands, denies attempting to bypass the law and says it is merely seeking to guide customers to their favorite brands. But researchers said they recognize the packaging changes as a tactic the industry has rolled out in other countries with stringent tobacco rules.