The Food and Drug Administration said Wednesday that an analysis of leading brands of electronic cigarettes, which deliver nicotine without smoke, detected carcinogens and a chemical used in antifreeze that is toxic to humans.

Officials at the FDA and other public health experts cautioned consumers against using the products, saying their health effects are unknown.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Commissioner Margaret A. Hamburg.

The FDA studied the ingredients in cartridges from two leading brands of electronic cigarettes. In one sample, it detected diethylene glycol, a chemical used in antifreeze. Other samples turned up carcinogens, including nitrosamines, the agency said.

The FDA considers the e-cigarettes to be drug devices and says makers must first get federal approval to market them. It has refused to allow their importation.

In May, two e-cigarette suppliers filed suit against the FDA to allow the shipments, claiming that the regulatory agency has no authority over the products. The suit is pending in a D.C. federal court.


© Washingtonpost

The Food and Drug Administration, recently granted the authority to regulate tobacco as a drug, is taking aim at electronic cigarettes — battery-powered cigarette look-alikes that deliver nicotine and produce a puff of odorless vapor.

Tests show that e-cigarettes contain “known carcinogens and toxic chemicals,” including diethylene glycol, an ingredient used in antifreeze, officials announced Wednesday during a teleconference. The FDA notes that the products have no warning labels.

Over the past year, the FDA has seized 50 shipments of e-cigarettes, which the agency considers to be combination drug/medical devices, says the FDA’s Michael Levy. Companies were marketing the products illegally, because they hadn’t gotten FDA approval for new drugs or medical devices, says Joshua Sharfstein, principal deputy commissioner of the FDA.

The FDA is reviewing the new tobacco law and considering a range of enforcement actions, which could include recalls or even criminal sanctions, Levy says.

E-cigarette makers say their products can be used anywhere and don’t produce secondhand smoke. In April, one maker, Smoking Everywhere, filed a federal lawsuit against the FDA, claiming the agency doesn’t have the jurisdiction to regulate its products.
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Health advocates, however, say that e-cigarettes are being marketed to kids. By adding flavors such as bubble gum, e-cigarettes could get children hooked on nicotine and serve as a gateway to tobacco, says Jonathan Winickoff, chair of the American Academy of Pediatrics’ Tobacco Consortium, who spoke at the FDA’s teleconference. He notes that the products are sold online and at shopping malls, where their marketing videos are seen by children and teens.

Ads make e-cigarettes look sexy and grown-up, says Matthew McKenna of the Centers for Disease Control and Prevention. And seeing adults use them in public places that are normally smoke-free could make kids think that smoking — of any kind — is normal and safe, he says.

On its website, the Electronic Cigarette Association denies marketing to children. It notes that the $100 cost of an e-cigarette starter kit — and the added cost of refill cartridges — make them unaffordable for kids.

Ron MacDonald, president and CEO of Crown7 e-cigarettes, says he’s just trying to give smokers an alternative to tobacco.

“The bottom line is that if a smoker wants to smoke, they are going to smoke regular cigarettes,” he says.
Usatoday

It took more than a decade for Congress to grant the U.S. Food and Drug Administration authority to regulate tobacco products.

Now that the FDA has been given that job, the agency must set up a new center devoted to regulating a multibillion-dollar industry that employs tens of thousands of people — many of them in the Richmond region. The industry reaches from farm fields to retail stores, has more than 40 million U.S. customers and has long enjoyed a high degree of autonomy.

“It’s a daunting task,“ said Mitch Zeller, a former associate commissioner of the FDA and a longtime tobacco-control advocate.

“There is no infrastructure at FDA yet” geared specifically for tobacco regulation, Zeller said. “It can be built, and it needs to be done quickly. That will happen simultaneously with FDA beginning to meet the deadlines that are in the legislation,“ such as a Sept. 29 ban on candy-flavored cigarettes.

The legislation, passed by Congress and signed by President Barack Obama on June 22, calls for the creation within 90 days of a Center for Tobacco Products in the FDA.

Observers say the new tobacco center likely will be structured in a similar fashion to other FDA offices, such as its Center for Food Safety and Applied Nutrition, which is responsible for making sure the nation’s food supply is safe, and its Center for Drug Evaluation and Research, which regulates over-the-counter and prescription drugs.

But the tobacco center will have a unique role for the FDA — regulating a product that, when used as intended, causes disease and death for more than 400,000 of its consumers in the U.S. each year.

In that light, the FDA’s approach to tobacco will likely be “a hybrid” of the way it regulates foods, drugs and devices, Zeller said. Tobacco doesn’t fit clearly into one of those categories, but it has characteristics of all of them.

“Tobacco is in a category by itself, given its inherent toxicity,“ Zeller said. “Having said that, I think the regulatory tools that [the FDA] will use in this unique category are pretty much the tools that we have seen the agency use for as long as there has been an FDA.“

Those tools include pre-market evaluation of products, scrutiny of marketing claims, and ingredient disclosures, he said.

Yet some issues are still left open to interpretation in the FDA legislation. For example, it requires the FDA to set product standards for tobacco that must be “appropriate for the protection of public health,“ rather than the “safe and effective” standard used for pharmaceuticals.

“That’s pretty broad,“ said Scott Ballin, a tobacco and health policy consultant who lobbied for FDA regulation of the industry. “There are going to be a lot of questions as to what the agency decides to do with that. Are they going to be reasonable standards? Are they going to be economically feasible standards?“

There is a whole spectrum of new, complex issues that need to be addressed carefully and openly and in a way that will achieve public-health goals,“ Ballin said.

The FDA’s decisions on tobacco regulations should be based on scientific evidence, Ballin and other tobacco-control advocates said. view was echoed by the nation’s largest tobacco company, Henrico County-based Altria Group Inc., parent company of Philip Morris USA.

“The FDA has a history of making decisions using a thoughtful, science-based process that includes input from the public, other stakeholders and the regulated community,“ said Bill Phelps, a spokesman for Altria Group Inc. “We believe whoever leads the [FDA] tobacco center should follow the same model, and we are hopeful that would be the case.“

Much of the decision-making on implementing the regulations will be made by the director of the Center for Tobacco Products, who has not yet been hired. The FDA closed its application process for the director position on July 9. The agency would not comment on how many people have applied, but a director is expected to be named within 45 days.

The director will have to build a staff, likely to eventually include hundreds of people with various scientific, regulatory and legal backgrounds.

The job description posted by the FDA for the director’s job called for applicants with “substantial scientific expertise” in areas such as toxicology and epidemiology, and experience in public health and “administrative procedure and regulation, including deep familiarity with congressional operations and policymaking in the executive branch.“

Whoever fills that role, said Matt Myers, president of the Campaign For Tobacco-Free Kids, “will need to be someone with exceptional leadership and management skills, and an ability to create a vision, build a staff, set priorities and meet deadlines under intense scrutiny on a highly controversial topic.“

The FDA also must appoint a 12-member scientific advisory board on tobacco products to provide recommendations and advise the agency on product regulations. That board will be heavily weighted toward public health, with seven members from medical, health-care or scientific fields. Two members will represent the interests of tobacco manufacturers, and one member the interests of tobacco farmers, but they will be nonvoting members, serving in what the legislation calls a “consulting” role.

Before it sets product standards, the agency likely will seek out information from the tobacco industry itself, Zeller said. The legislation requires tobacco companies to disclose product ingredients to the FDA, but the agency can also go further than that by requiring companies to submit their research on toxic compounds and the health impacts of products.

“Right now much of the scientific knowledge about the delivery of toxic compounds in smoke is in the hands of the tobacco companies,“ he said. “One of the tools in the legislation that I think is very important is the power that FDA is given to demand health-related information from the companies.“

Zeller headed the FDA’s office of tobacco programs from 1993 to 2000, after the agency had asserted authority to regulate tobacco products. Tobacco companies disputed that in court, and in 2000 the U.S. Supreme Court ruled that only Congress could grant the agency regulatory power over tobacco.

In the 1990s, Zeller said, the FDA had primarily focused on ways to prevent youth smoking, but the agency’s ability to continue that work was always in doubt because of the lawsuit. “Congress has spoken now,“ he said. “The day is here when those tools have been given to the agency.“

John Reid Blackwell is a staff writer at the Richmond Times-Dispatch


© Godanriver

You have to hand it to entrepreneurs in the electronic cigarette business. In a time of economic recession, they are creating wealth, jobs and scores of tobacco converts.

Electronic cigarettes look like the real thing, but they are battery powered to deliver nicotine in a vapor rather than tobacco smoke.

Calls in Washington that e-cigarettes be banned from the market because of unknown health risks haven’t stopped people from buying. The smokeless smokes have been on the U.S. market for about two years, and already they are being sold in about 4,000 retail outlets, according to an industry group.

The device is simple: The battery, which resembles white tobacco-filled paper, joins with a replaceable cartridge filled with liquid nicotine solution. Draw on it like a cigarette and the battery heats the solution, producing a cloud of nicotine-enriched vapor that looks like smoke, but isn’t.

It’s clean, which has an eco-conscious appeal; no ashes, no stink, no butts littering the landscape. You can indulge anywhere without breaking no-smoking rules.

“It’s providing your body with nicotine without the secondhand smoke, without the tar and without the carcinogens,” said Mike Patrick, who sells e-cigarettes at the Smoke 51 kiosk at Beachwood Place. “This is a healthy alternative to smoking cigarettes, and it’s a lot cheaper.”
“We figured this is a no-brainer, it’s healthier, but apparently not everyone looks at it that way.” — Sebastian Cangemi, President of Liberty Stix in Willoughby
But health groups have raised alarms about the lack of safety data. The American Lung Association, American Heart Association and others came out in support of a call from Sen. Frank Lautenberg, a New Jersey Democrat, that the Food and Drug Administration take them off the market.

The FDA says the devices are subject to enforcement action because it considers them unapproved drug-delivery devices. The agency has stopped some shipments from China, but it has not taken steps to remove the products from the market.

“We don’t know what the health effects are. It’s not been studied,” said Shelly Kiser of the American Lung Association of Ohio. “Who knows what happens when you breathe vaporized nicotine into your lungs?”

Industry frontman Matt Salmon, a former U.S. representative from Arizona, has been busy trying to fend off regulators and critics. Salmon heads the Electronic Cigarette Association, which formed in the spring. He said in a prepared statement that electronic cigarettes are safer than tobacco, and he argues the FDA has no jurisdiction to regulate them.

On a video posted on the industry Web site, Salmon says: “Whatever is said, remember this: Withholding electronic cigarettes from the market is like telling someone who chooses to smoke that his or her only legal option is to smoke cigarettes, which is the leading cause of preventable death in the United States.”

Dr. Scott Frank, director of the public health program at the Case Western Reserve University medical school, said even if e-cigarettes help people quit tobacco, nicotine-replacement products require FDA approval.

“I would never advocate for electronic cigarettes to be available in unregulated fashion,” Frank said.

None of that seems to matter to customers. U.S. sales this past year are around $100 million, and they are on pace to double, the association says.

A Willoughby company called Liberty Stix opened for business 11 months ago, and is now selling e-cigarettes to retail outlets and individual customers across the country. The company occupies 17,000 square feet of industrial park space, where four employees take phone orders and several others fill orders for shipping.

Liberty Stix, which sells starter kits for about $40, is working on deals to place the product in casinos, retail chains and military installations, said President Sebastian Cangemi.

“Where smoking bans are in effect, we do advertising,” said Cangemi.

He said he’s concerned about calls for e-cigarettes to be pulled off the market, “but hopefully they’ll look at it without fogged glasses.” The company is working with research labs in Ohio, New Jersey and Texas in hopes of showing that the devices are safer and healthier than tobacco, he said.

“We figured this is a no-brainer, it’s healthier, but apparently not everyone looks at it that way,” Cangemi said.

Cangemi had approached Iyaad Hasan, director of the Cleveland Clinic Tobacco Treatment Center, about recommending Liberty Stix as an alternative to cigarettes. Hasan said in an interview he considered it but declined. He said part of addiction treatment is breaking hand-to-mouth behavior. “We push breaking the linkage to a cigarette,” he said. Critics also say that nicotine itself can affect blood pressure, insulin and cholesterol levels.

Daniel Vaughn, 63, heard about Liberty Stix from a radio ad. The Cleveland resident said he smoked a pack and a half of regular cigarettes a day. Like most customers, Vaughn decided to try electronic cigarettes to help him quit tobacco, even though e-cigarettes are not approved for that purpose. Vaughn said they worked, though it took several months of electronic smoking to wean himself off tobacco.

“When I first wake up in the morning, I hook in a new cartridge and puff away,” Vaughn said.

Cartridges can be bought with varying amounts of nicotine, or no nicotine at all. The nicotine is contained in liquid propylene glycol, a chemical that produces the vapor. A cartridge lasts about as long as a pack of cigarettes, and they come in flavors such as chocolate, apple, mint and coffee.

The flavorings have prompted criticism that the industry is targeting young people. Cangemi said most of his customers are older, “because they realize their mortality.”

Patrick, whose family opened the Beachwood kiosk in May, launched into his pitch to two young women who stopped by one recent afternoon.

“Will this help her stop smoking?” Martika White asked, pointing to her friend, Bianca Johnson, 22. “I want to help her stop. I’ve been talking to her about it.”

Patrick explained how it works, and then demonstrated by drawing on an e-cigarette and blowing out a vapor stream. Johnson said she’d consider it and walked away with a business card.

“Now they’re thinking about it,” Patrick said. “That’s about as good as a sale.”


© Cleveland

VIRGINIA BEACH, VA – Electronic Cigarette announces that its electronic cigarettes are a new, revolutionary alternative to traditional cigarettes.

Also known as an electric cigarette or e-cigarette, these smokeless cigarettes have no tar and no known carcinogens. These electronic cigarettes also avoid exposing others to second hand smoke since they don’t require the smoker to use a flame and won’t cause the bad breath usually associated with traditional cigarettes. Unlike traditional cigarettes, electronic cigarettes are legal in bars, restaurants and other public places for smokers over 18.

Smokers need to purchase an electronic cigarette kit to get started. The kits sold by Premium Electronic Cigarette come complete with the cigarette, an extra rechargeable battery, wall and USB chargers and refill cartridges. The refill cartridges are available with different levels of nicotine in them, including high, medium and low.

The refill cartridges are filled with water, propylene glycol, nicotine and a special scent that imitates the flavor of a traditional cigarette. Inhaling on the cigarette gives the smoker the feeling of a traditional cigarette and triggers the cigarette to release a puff of vapor mist that looks like smoke but evaporates harmlessly in just a few seconds.

The cigarette’s battery is triggered by inhaling and automatically stops once the smoker stops. Because of this, the electronic cigarette is safe to use in the home or car and even allows smoking everywhere, such as in bed, something that’s highly dangerous with a traditional cigarette.

Electronic Cigarette refill cartridges are available in a variety of flavors such as tobacco, menthol, vanilla, chocolate and cherry. Flavors are available depending on the cigarette’s model and can be purchased directly from Electronic Cigarette Stores.

Growing up in the ’60′s, marijuana was the preferred recreational drug of my generation. While beer and other alcohol may have been the choice of the fraternity crowd, the cool kids recreational drug of choice was marijuana.

Living close to Santa Monica Bay, my wife and I frequently stroll the Venice boardwalk to soak in the flavor of the beach and witness the antics of the wacky local Venetians. For the last several years, we couldn’t walk the boardwalk without being approached by a local vendor inviting us to meet with a local doctor to get our marijuana prescription filled. “Whatever ails you, marijuana will cure you”.

I always considered the prospect of decriminalization of marijuana as a positive step since its use was no worse than alcohol or cigarettes and enforcement of antiquated marijuana laws were a waste of resources. I really didn’t believe that marijuana had a legitimate medical use but, with a wink and a nod, I supported initiatives designed to legalize its use.

Well, it looks as though current marijuana research may be changing my original opinion of its medical benefits. According to an L.A. Times article, recent research points to the following benefits and risks of marijuana consumption:

THE GOOD

Pain:

Marijuana has been shown to be effective against various forms of pain ranging from chronic low grade pain to severe pain and seems to be effective against nerve pain that’s resistant to opiates.

Cancer:

While no one is arguing that marijuana will cure cancer in humans (at least not yet), it has been shown to be effective in combating pain, nausea and loss of appetite in cancer patients undergoing traditional cancer treatments. According to an October 2003 review article in the journal Nature, marijuana may even have a positive effect on blocking the growth of tumors in lab animals.

Other Potential Benefits:

Multiple Sclerosis

AIDS wasting syndrome

Muscle spasms

Tourette’s syndrome

Glaucoma

THE BAD

Addiction:

The same National Institute on Drug Abuse that has yet to determine whether marijuana increase the risk of lung and other cancers, says that repeated use could lead to addiction and heavy users may experience withdrawal systems such as irritability and sleep loss if they stop suddenly.

Respiratory disease:

Several studies in New Zealand and Australia have concluded that smoking one marijuana joint is at least 2.5 times more harmful to the lungs than one cigarette and that pot smoking can lead to one type of lung disease 20 years earlier than cigarette smoking.

Psychological effects:

It appears that heavy pot smoking affects the parts of the brain that controls memory, attention and learning. (Those readers who have partaken in this herb can relate to that last sentence). Also, studies have showed loss of tissue in two areas of the brain, the hippocampus and amygdala which are areas of the brain that are rich in receptors for marijuana and are a vital memory and emotional region of the brain.

THE ANSWER

Perhaps a way to overcome the adverse health concerns that will allow consumers to reap the benefits of marijuana is to not smoke marijuana (as a joint or in a pipe) but to inhale its vapor. According to a study published in 2007 in Clinical Pharmacology and Therapeutics, vaporizing is a safe and effective way of getting THC, the active ingredient, into the blood-steam and does not result in consuming toxic carbon monoxide.

While inhaling marijuana vapor and not its smoke will help alleviate the adverse physical affects; regular, heavy non medicinal pot smoking or THC vapor ingestion should be avoided. It’s not good for your brain. Otherwise, contrary to the original conventional wisdom, for some of us marijuana may offer more benefits than risks.
© Examiner

For the first time in the history of Drew Estate, the company best known for making infused and flavored cigars will be making a non-flavored, premium national brand for a third party—namely Dion Giolito, the man behind Illusione cigars.

The new Illusione Nosotros, which translates to “us” in Spanish, refers to the collaboration between Giolito and Drew Estate founder Jonathan Drew. While this is not Drew Estate’s first foray into the world of non-infused premium cigars, this is the first time that Drew Estate will be making a traditional premium mark for someone else.

“Moving into the traditional market for us was a real challenge because many cigar smokers had a preconceived notion about Drew Estate,” said Jonathan Drew. “They thought of us as the ACID guys or the infusion guys. It was really the opening of our factory Gran Fabrica Drew Estate that moved us towards all areas of tobacco, including the nonflavored traditional market.”

ANKARA – Patrons of a usually smoke-filled hookah bar stepped outside to light up yesterday as Turkey extended a ban on indoor public smoking to bars, restaurants and coffee houses.

The ban in this nation of smokers came into effect despite protests from bar and coffeehouse owners who fear it will ruin businesses that have already been hit by the economic crisis.

“The country woke up this morning having carried out a cigarette revolution,” an editorial in the newspaper Radikal read.

“Smokeless life has begun,” was the headline on the Milliyet paper.

In Ankara’s Sakarya St – famed for its fast food outlets, bars and beer halls – owners staged a brief protest saying many of the businesses there risked bankruptcy.

“We are good for the summer, as we can go outside, sit outside. But in winter it will be a problem,” said Fatih Toprakkale, owner of Calcene hookah bar. “I am afraid that we may eventually have to close, which will be a shame as we employ about 15 people.”

Prime Minister Recep Tayyip Erdogan’s Islamic-oriented Government widened a ban that already covered offices, public transport and shopping centres to now include bars and restaurants, intent on reducing smoking rates and the effects of secondhand smoke. The Government says the previous prohibitions on indoor smoking have already cut smoking rates by 7 per cent.

The smoking ban brings Turkey in line with practices in the European Union, which it hopes to join. Under the new legislation, patrons violating the ban will be fined 69 Turkish lira ($69.70), while owners who do not enforce the ban could be fined between 560 and 5600 lira.

Members of a 4500-person team established to enforce the new ban began carrying out surprise checks on bars and restaurants in Ankara and Istanbul, the state-run Anatolia news agency reported.

An association of coffee house owners said it would take legal action to try and have the ban overturned, saying it would take 70,000 establishments to the brink of ruin.

Yesilay, an organisation devoted to reducing alcohol and tobacco consumption, says around 40 per cent of Turks over the age of 15 are smokers, consuming around 17 million packs a day.

Hopefully, one learns from previous mistakes. The parallels between then and now, are not easily dismissed.

Recently, the California Office of Environmental Health Hazard Assessment declared that marijuana smoke causes cancer. Whether that call came from a statistical evaluation or hard science, we should be able to extrapolate from tobacco’s history how big a mistake adding another toxic drug to those already legal would cost society.

Can you recall the unethical tactics tobacco companies used or have you been told? Is the same thing going on with marijuana proponents?

In 1964 the Surgeon General, Dr. Luther L. Terry, issued a report stating that cigarette smoking was the primary cause of lung cancer. The 1971 book “Cigarette Country”, written by Susan Wagner, documented how the tobacco industry and the media worked together to discredit the surgeon general’s report and keep the public in the dark.

This same phenomenon is going on today with illicit drugs, particularly with marijuana and ecstasy, the two drugs favored by the media.

In 1968 Free lance writer Stanley Frank wrote an article for True Magazine entitled “To Smoke or Not to Smoke — that Is Still the Question,” which concluded that the “hazards of cigarette smoking may not be so real as we have been led to believe”(1) and that “Statistics alone link cigarettes with lung cancer, a correlation that is not accepted as scientific proof of the cause and effect.”

He stated further that “…there is absolutely no proof that smoking causes human cancer.” (2).

A few months later another article “Cigarette Cancer Link Is Bunk” echoing the exact same refrain, appeared in the National Inquirer. This article carried the byline Charles Golden. In 1968 a curious senator, Warren Magnuson, asked the new Surgeon General, William H. Stewart to take a look at the two articles. It was discovered that Frank “worked for a public relations firm that had been on retainer to the Tobacco Institute since 1963.” Alerted to a possible conspiracy, writer Ronald Kessler of the Wall Street Journal looked into the matter and found that that at least 600,000 copies of the True article had been sent out by a Tobacco Institute PR firm to influential individuals throughout the country, and further, that writer Stanley Frank had authored both articles. (3)

The FTC inquiry further found that a tobacco company attorney had supplied Stanley Frank with “the materials used in writing the True article.”. … the result is the purest trash–dated, biased and without present justification.” (4)

Surgeon General Stewart stated that “According to the Public Health Service, the True article conformed to a pattern of attack on former Surgeon General Terry and his advisory committee on smoking and health.” Dr. Terry had stated several years earlier that such attacks “are repetitious and cleverly manipulated in a continuing program to shake public confidence in the [Surgeon General's 1964 tobacco] Report.” (5)

This was despite the fact that “…the most common type of lung cancer–bronchogenic or squamos-cell carcinoma–occurs almost entirely among cigarette smokers and rarely in those who have never smoked.” (6)

What we see here is a complicity of the media in writing articles supporting a political agenda rather than doing the labor-intensive investigative reporting necessary to provide an unbiased and factual story.

The most glaring example of this today, and an exact parallel, are the articles being written by John Cloud of Time Magazine. Last February Cloud was one of the plenary presenters at a San Francisco conference promoting Ecstasy.

The “State of Ecstasy” conference was co-hosted by the Soros-funded Lindesmith Center, directed since its inception by pro-drug proponent Ethan Nadelmann. Cloud stated, “… Ethan [Nadelmann] … He calls me every couple of months about pitching stories.

Cloud has recently written another article for Time Magazine titled “This Bud’s Not for You,” protesting the Drug Enforcement Administration’s position against the use of hemp oil in food products.

… This is not journalism. At best, it is ‘tabloid-ism.’ The beat goes on … more tomorrow, but are you seeing a pattern here yet?


© Examiner