Almost without fail, news articles that attacks the e cigarette has comment areas that are filled with doctors and scientist, along with multitudes of the population showing evidence of the need, want and support for this amazing new product that most ex smokers are calling a “lifesaver”.

Since the FDA was exposed on the faulty testing procedures during their preliminary test on the e cigarette, and using personnel on the advisory board that have clear conflicts of interest concerning the e cigarette industry, the general pubic is already showing signs of looking for other means to get the e cigarette and claiming that they will not use tobacco or what they refer to as “worthless” smoking cessation products by the same pharmaceutical companies that are funding the special interest fight against them.

400,000 smokers a year die from tobacco related illnesses in the United States each year while legislators and special interest protect tobacco companies from being banned through legislation that insulates tobacco and cessation markets from products that do work to eliminate tobacco.

by Tiffany Ellis, original article OfficalWire.

Consumers said the FDA needs to more rigorously oversee clinical trials to ensure patients get treated fairly; doctors urged the FDA to flag safety concerns with drugs and devices as quickly as possible; and scientists recommended the agency air dissenting opinions by FDA scientists.

These thoughts were balanced, in part, by industry representatives who said that, while they agree the FDA should explain decisions more thoroughly, confidential commercial information shouldn’t reach public eyes.

The meeting is part of an effort underway at the FDA to undermine accusations that it operates like a black box, making decisions without explaining them. The FDA has long faced criticism, some of which was repeated at the meeting, that it sits on safety information that should be public and works too closely with industry.

It’s too early to tell what recommendations, if any, the agency will implement. But FDA officials, including Deputy Commissioner Joshua Sharfstein, and the heads of nearly every division within the agency, eagerly questioned consumers and scientists about their recommendations and said over and again they looked forward to reading more details in written testimony.

Steve Findlay, a senior health-policy analyst at the Consumers Union, said the FDA should tell the public, through its Web site, whenever agency officials have meetings with industry representatives. Such disclosure, Findlay said, would help restore the FDA’s credibility. FDA officials appeared open to the idea, but questioned what meetings would warrant telling the public about.

Findlay said “important” meetings, but acknowledged the FDA will have to decide what that means.

This highlights a broader challenge the FDA will wrestle with as it decides to make decisions more transparent: What should it release? What can it release? And is there such a thing as ‘too much information’?

For instance, Francesca T. Grifo, of the non-profit Union of Concerned Scientists, said the agency should allow FDA scientists to publicly air opinions about a drug or medical product when they disagree with a final agency decision.

Sharfstein questioned such a move, saying scientists often “disagree sharply,” and airing those differences might erode the public’s trust in FDA decisions.

“I don’t think that the idea that we might confuse someone is powerful enough to actually silence an opinion that might in fact save a life,” Grifo said.

By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@ dowjones.com

That’s because they are electronic cigarettes, or e-cigarettes. These battery-powered devices do not create smoke but provide a mist of nicotine to the user’s lungs.

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.

One airline, Ryanair, which mainly operates in Europe, not only permits their use on flights, but also sells them to passengers. Some “no smoking” restaurants in the United States are permitting their use, say advocates for the product.

The devices are also available as e-cigars and e-pipes.

“Two years ago, no one had ever heard of these things,” says Matt Salmon, president of the Electronic Cigarette Association (ECA) in Washington.

“Today, there is an estimate there are 300,000 users, but I think it’s in excess of that,” says Mr. Salmon, an antismoking advocate and former congressman.

In the e-cigarettes, most of which are made in China, there is no combustion of tobacco. Instead, the device contains a lithium battery. That heats up an atomizer, which turns the nicotine into a vapor.

When the user inhales the vapor, the device’s tip glows with a red LED light to mimic the experience of smoking a cigarette.

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 July, the FDA did preliminary research, buying some of the products online and at shopping-center kiosks. The products were “inconsistent” in their levels of nicotine, Ms. DeLancey says.

However, some of the urban legends about the FDA wanting to ban the products are not true, DeLancey says. “What we are saying is for them to be sold, you should be able to evaluate how safe and effective they are – especially if they are a smoking replacement used over several years, perhaps a lifetime,” she says.

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.

Article by By Ron Scherer | Staff writer of The Christian Science Monitor.

They are also praising Gov. Arnold Schwarzenegger’s recent decision not to veto a bill that could have banned the sale of the product in the state.

The typical electronic cigarette mimics a real cigarette but is not lit and does not produce any smoke. It allows users to puff on it to produce heated nicotine mist.

“It doesn’t make sense to try and take a product that does not have carbon monoxide or tar and remove it while the product that is known to kill is not banned. We’re happy that common sense has prevailed,” said Matt Salmon, president of the Washington D.C.-based Electronic Cigarettes Association.

A significant difference between the electronic cigarette and actual tobacco is that it allows users to modify their levels of nicotine, said Gregory Puetz of Fontana.

For more than a year, Puetz has been independently selling the product because he feels it is a viable alternative to tobacco.

“I’m not against regulation and making sure it doesn’t get to the under-aged,” he said. “It allows (smokers) to decide what they want to do.”

For Salmon, a former Arizona state senator, the driving forces behind the bill were special interest groups and the tobacco industry, which may have felt that electronic cigarettes could pose a threat to tobacco sales.

“Cigarettes kill 400,000 people every year. We haven’t had any single (electronic) cigarette that has harmed someone’s health,” he said. “It makes one wonder what the motivation is.”

Salmon said he wouldn’t mind if the lawmakers tried to rewrite the bill so that it regulates the age of users, which he said was the original intent of the bill.

But Salmon said he knows the medical field is split on the product.

The product has not been approved by the U.S. Food and Drug Administration or the World Health Organization.

WHO has said there is a need to strengthen global tobacco product regulation on products such as electronic cigarettes.

Americans for Nonsmokers’ Rights is disappointed in the governor’s veto, said Annie Tegen, senior program manager for the Berkeley-based advocacy group.

“We don’t believe these products are safe, and we see it as a valid health concern,” Tegen said.

In July, the FDA released a preliminary study which found that the product contains carcinogens, she said.

But in order to fully understand the health implications of smoking electronic cigarettes, more research needs to be conducted, Tegen said.

Despite the insufficient amount of testing, Tegen said the organization believes the electronic cigarette should not be considered as a substitute for smoking tobacco cigarettes and is concerned about the risks of inhaling second-hand smoke from the electronic version.

For that reason, Tegen said users of the “e-cig” should not smoke it indoors.

Puetz said he thought the bill was bad policymaking from legislators, due in part to misinformation about the product.

Both Puetz and Salmon said they have become advocates for the industry because they feel it’s a viable alternative.

The governor’s decision could have implications nationally, Salmon said.

“California policy has always been a harbinger of things to come for the rest of the country,” he said. “A lot of national policy starts in California and this will send a message to the rest of the country.”

By Liset Marquez.
Original article & comments on DailyBulletin.

The Food and Drug Administration on Thursday began collecting millions in fees from the nation’s tobacco companies to help fund the agency’s newly granted authority to regulate the industry.

The user fees, which will be collected quarterly, are based on each company’s share of the U.S. tobacco market. The FDA will collect about $23 million for fiscal 2009. That will rise to $235 million in 2010 and grow to $712 million by 2019.

The FDA would not disclose the assessments for specific companies.

Stifel, Nicolaus & Co. analyst Christopher Growe said in a note to investors that Richmond, Va.-based Altria Group Inc., owner of market-leading Philip Morris USA, would be responsible for about 50 percent of the fees.

FDA spokeswoman Kathleen Quinn said the fees will be used to fund the Center for Tobacco Products, the agency’s group tasked with regulating tobacco. The fees will pay for staffing, offices, systems that will be used to register products and outside contractors.

In June, President Barack Obama signed the law that allows the FDA regulate the industry. Its authority includes the ability to ban certain products, reduce nicotine in tobacco products and block labels such “low tar” and “light.” Tobacco companies also will be required to cover their cartons with large, graphic warnings.

The law doesn’t let the FDA ban nicotine or tobacco outright.

The Congressional Budget Office estimated in June that the law would reduce the number of underage tobacco users by 11 percent by 2019 and lead to a 2 percent decline in smoking among adults.

Altria supported the legislation, while its chief rivals — No. 2 Reynolds American Inc. and No. 3 Lorillard Inc., both based in North Carolina — opposed it. The latter two have joined in a lawsuit with other smaller tobacco companies challenging specific marketing regulations of the law.

The nation’s tobacco companies already pay $1.01 per pack that it sells for federal excise taxes, and the top cigarette makers also make yearly payments as part of the landmark 1998 tobacco settlement to reimburse states for smoking-related health care costs.

In that settlement, tobacco companies agreed to make about $206 billion in annual payments over more than two decades. Companies also make payments as part of legislation that ended the federal tobacco program, a quota program that limited and stabilized the amount of tobacco produced by farmers.

By Michael Felberbaum, BusinessWeek.

These lies are of a piece with the tendency of anti-smoking activists and public health officials to obscure or deny the differences in risk between tobacco products. To judge from their comments, someone who enjoys an occasional cigar or uses snus might as well smoke a pack of cigarettes a day. And now they are suggesting that e-cigarettes, which are not even tobacco products but superficially resemble them, might be just as hazardous as conventional cigarettes. The peristent refusal to admit that differences in risk matter, or that they even exist, does not make sense even from a paternalistic “public health” perspective, which would suggest it’s a good thing for people to use snus or e-cigarettes instead of smoking, since the substitution reduces total morbidity and mortality. This black-and-white attitude seems to be driven by a combination of pharmacological puritanism and bureaucratic stubborness that does not bode well for the FDA’s ability to rationally regulate tobacco products.

Article by Reason Foundation, view the original article and comments here.

Every evening, she plugs her battery-operated electronic cigarette into a charger. She no longer carries a lighter or sucks breath mints all day in the office.

“I call myself a non-smoker,” says Moraffah, a 54-year-old executive assistant from Tustin, Calif. “I thank God this came into my life. I’m healthier than I was smoking tobacco. There are other advantages. I don’t want to smell like a cigarette.”

E-cigarettes contain cartridges of nicotine that release an inhalable vapor. There’s no odor or smoke. They’re marketed as a safe alternative to tobacco’s lung-choking tar and cancer-causing carcinogens.

But those claims are disputed by the Food and Drug Administration. In July, the agency warned that the smokeless cigarettes are harmful. A government analysis of the made-in-China product found carcinogens and toxic chemicals. In a pending case, the FDA has been sued over its jurisdiction to regulate the e-cigarettes.

“Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user,” the FDA said.

Craig Youngblood, founder of In Life, an Irvine distributor of e-cigarettes, disputes the lab findings and said his products contain ingredients that are safe and nontoxic.

“We’re an alternative to tobacco,” Youngblood says. “We’re not saying we’re going to give you big muscles or you’ll live to 130 … Caffeine and nicotine are not that dissimilar. What’s next? Telling you how many cups of coffee you can have?”

The models vary. Moraffah prefers a device that looks like a fancy ink pen. Another resembles a regular cigarette except the bright end is blue, not the color of a flame. E-cigarettes cost about $100, plus the cost of nicotine cartridges in various strengths. The devices carry a warning label saying they have not been approved by the FDA for smoking cessation and should be kept out of reach of children.

“We don’t want to look like a cigarette,” Youngblood says. “We’re in reality, an anti-cigarette.”

Youngblood talks like he’s on a crusade against cigarettes. He cites forest fire statistics, the pounds of discarded butts littering beaches. Not to mention the federal government’s calculation that more than 430,000 premature deaths each year are caused by tobacco or secondhand smoke.

But that’s where he and many other anti-smoking advocates depart.

Dr. Ira J. Strumpf, a pulmonologist who teaches at UCLA and is a spokesman for the American Lung Association, said e-cigarettes have not been independently proven as a safe alternative to tobacco.

“The vapor that you inhale is not without risk,” Strumpf says. “It’s not pure nicotine. It has with it some contaminants. When the FDA looked at 19 of these cartridges, they found half the samples contain impurities that are known to be toxic to humans. At least one cartridge contained diethylene glycol, one of the toxic compounds of antifreeze.”

Strumpf said he’s concerned that e-cigarettes are marketed to people who want to quit smoking but also to those who have never smoked before. “The fact they present them in the shape of a cigarette, they’re trying to capitalize on the social aspect of smoking and trying to promote the social appeal of smoking.”

Brad Rodu, a tobacco researcher at the University of Kentucky in Louisville, considers e-cigarettes a better alternative for smokers who absolutely can’t break their addiction.

“We can’t say these are perfectly safe, but with everything we know about them we can certainly say they are vastly safer than continuing to light cigarette tobacco on fire and inhaling the 3,000 or 4,000 chemicals that cigarette smokers are doing right now,” Rodu said.

Peter French, 52, has become such a fan of the e-cigarette that he’s started selling them with In Life. He puffs his in restaurants, the bank, even in church. He said he enjoys the novelty and the curious looks and questions.

“This has literally saved my life,” says the Laguna Beach resident, exhaling puffs of vapor that quickly disappear. “My sense of smell is definitely back, taste. I can enjoy things.”

French said he tried quitting smoking with the patch, gum and medication designed to reduce cravings. But he missed the oral satisfaction of a cigarette, which he said e-cigarettes replicate.

“You get the hand to mouth, you get the vapor. Inhaling that vapor is almost exactly the same as what it feels like to smoke,” he says. “We just want the nicotine. We don’t want the other stuff in the tobacco.”

I must concede that diethylene glycol is indeed toxic. That much is true. But how toxic is it? It possesses one-tenth the toxicity of household aspirin, not to mention one-fortieth the toxicity of nicotine, the primary component of e-cigaratte vapor which is administered in much higher doses. So why is the FDA focusing on diethylene glycol? Because if they told you that e-cigarettes contain trace amounts nicotine, you’d stare blankly, shrug your shoulders, and take another long satisfying drag off of your e-cigarette before blowing a bunch of vapor in their faces. But when somebody starts throwing around a term like ‘diethylene glycol,’ people pay attention. Nobody knows what the hell it means and it doesn’t sound like something you’d necessarily want a tall frosty mug of.

Or does it? Diethylene glycol is also an ingredient found in toothpaste, mouthwash, cough syrup, dog food, wine and cigars among plenty of other consumer products. Do you know what it is not an ingredient of? Antifreeze. Propylene glycol is used in antifreeze. Diethylene glycol is used in coolants. Let’s get our scare tactics straight, shall we?

Click here to read the full article on 13 Guys Named Ed.

A major policy shift is underway, and it is bound to have a dangerous unintended consequence. The new team at the FDA has slapped a black box warning on an important class of drugs that treat inflammatory diseases such as rheumatoid arthritis, Crohn’s disease, and colitis.

The cancer risk highlighted by this new bold warning has been known for years — and hasn’t gotten worse. We already knew of the cancer risk in children and adolescents, and responsible doctors were cautious in using them. The new warning signals only a change in perception of risk, not any change in actual risk.

Physicians should still give due consideration to the benefits of the drugs, especially in light of the paucity of other treatments for debilitating and often dangerous inflammatory diseases. Consider the benefit versus risk analysis for inflammatory diseases with secondary risks.

For example, by not using these drugs out of possibly inflated concerns due to the new additional cancer warning, might inflammatory bowel disease patients face a higher risk of colon cancer as a result of years of inflammation? You won’t see that risk in bold print. But it is just as real. And this is precisely the problem with the FDA’s new policy, which is based on the assumption that erring on the side of more warnings is the safest way to go.

Similarly, this summer, the FDA warned about the safety of e-cigarettes, a product many smokers are using to quit smoking real cigarettes. E-cigarettes are devices that supply users with vaporized nicotine and look like cigarettes, many even having an LED light at the tip. These products, which contain no tobacco and are non-combustible, eliminate virtually all the risks of smoking. For the vast majority of smokers unable to quit even with the help of drugs and counseling, e-cigarettes could be a lifesaver.

Yet the FDA found tiny levels of carcinogens in the product and warned smokers to stay away, essentially telling them to go back to deadly cigarettes.

Unfortunately, it is no surprise that the new leadership at the FDA is taking a more aggressive stance with regard to warnings.

These warnings are a harbinger of how the agency will weigh benefits versus risks: with a thumb weighing down the risk side. This distorted approach has numerous downsides:

• Fewer patients will get the treatment they need, out of an “abundance of caution” and physicians’ fear of litigation.

• Black box warnings, originally meant for only the most dangerous drugs, will become more widespread but less meaningful.

• The FDA, newly armed with regulatory power over tobacco, will make it harder for people to quit smoking cigarettes by warning them away from disfavored alternatives.

• Investors and researchers (innovative drug companies) will have less incentive to pursue new medications that may attract scary warnings.

The old adage “better safe than sorry” is too simplistic in today’s world to be the guiding principle at the FDA.

New York City
ACSH is a non-profit group that accepts funding from a wide array of foundations, corporations and individuals.

A war is being waged between the FDA and electronic cigarette supporters.

The FDA wants to ban electronic cigarettes, claiming that they have not been adequately tested and therefore pose a threat to the American public. Supporters of the electronic cigarette say the FDA is being brash and using the media to feed incomplete, big corporation biased information to the American public.

Millions of smokers use the electronic cigarette, claiming that they have not had the urge to go back to traditional tobacco cigarettes. The electronic cigarette looks and feels like a tobacco cigarette, but that is where the similarities end. Tobacco cigarettes contain over 4,000 ingredients, many known carcinogens, while an e-cigarette contains only 20, none of which are carcinogenic. The FDA recent test results of electronic cigarettes found 1 out of 18 cartridges contained Diethylene glycol (DEG). However the FDA failed to mention that DEG is also used as a humectant in tobacco products such as cigarettes. By not providing all of the details, the FDA appears as if they intend on utilizing public perception to affect policy.

The FDA has not banned the products yet, but they are considering it. With millions of passionate users of electronic cigarettes, it is foreseeable that an underground black market will appear if the FDA bans e-cigarettes, much the way it banned alcohol during Prohibition.
Prohibition did little to reduce the demand for alcohol. Most experts and sociologists agree, prohibition was a complete failure and contributed greatly to the rise of organized crime. The alcohol industry became the province of gangsters operating a black market.
This is not what the electronic cigarette industry wants. They are willing to work with the FDA to approve these devices that have the potential to save lives. Matt Salmon, president of the Electronic Cigarette Association encourages the “FDA to take a more scientific approach and to work with members of the ECA before making any rash decisions to ban e-cigarettes altogether. Such a ban would leave smokers without an alternative to combustible cigarettes, which are clearly documented and known for their unhealthy and life-threatening results and which the FDA has no intention of banning. The enormous response our members have received from the more than 1 million Americans undoubtedly demonstrates that smokers unable to quit desperately are looking for an alternative to cigarettes.”
Smokers desperate search for an alternative to traditional cigarettes will infallibly create a black market if the FDA bans electronic cigarettes.

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