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Posts Tagged ‘FDA’

In this article in the Wall Street Journal about the FDA’s attempts at regulation, they talk to some people who get the concept completely right.

Things such as ”

Advocates — who say there is a nationwide grass-roots movement to keep e-cigarettes available — say the proof is in their health.

“I find it difficult to believe that my wheezing and productive morning cough would have magically disappeared sometime between March 2009 and now if I had continued smoking, waiting for someone to proclaim e-cigarettes 100 percent safe,” said Elaine Keller of Springfield, Va. She is vice president of the Consumer Advocates for Smoke-Free Alternatives Association.

“Why do politicians and organizations that claim to be protecting public health want to take away options that could save smokers’ lives?” she said Tuesday.”

and.. ”

The supporters of e-cigarettes are now watching New York “very closely. They kind of snuck up on us,” said Keller.

She said she has been tobacco free since March 2009 after 45 years of smoking. She said her group amounts to a grass-roots effort of those who feel the government has blocked this “miracle” product.

“There is no industry support on this thing at all,” Keller said of the organization. “We want to keep it this way so no one can say we are a shill for the tobacco, drug or e-cigarette industry.”

She also tries to recast the safety question.

“I can’t point to anything to say it’s 100 percent safe,” Keller said. “The thing is, it only needs to be safer. The only standard is that it’s safer than smoking.”"

That’s exactly it – are they perfect? I don’t know. But they are far better than smoking tobacco cigarettes, and that’s what matters to people. The people who want to buy electronic cigarettes are the people who know what matters most.

Go to Smokey Vapor to buy your electronic cigarettes.
Go to Smokey Vapor Updates for news and ratings of electronic cigarette companies and products.
Go to Soda Stream for more information about SodaStream products.

The LA Times has a piece on electronic cigarettes and the FDA’s attempts to get them regulated.

It seems from the LA Times that the main issue the FDA has, supposedly, with the electronic cigarettes and why they are trying so hard to get them regulated, is because with the system so open the way it is now they have found terrible breaches in quality, and they suspect that with no regulation, who knows what the manufacturers are actually putting into the ecigs – maybe some are putting in ingredients that are not healthy, maybe drugs (as some companies have been caught doing), etc.

Here is the article from the LA Times:
By late March, tobacco companies will have to reveal to the Food and Drug Administration what sorts of new additives they’ve recently put in their products. But the ruling doesn’t apply to electronic cigarettes, whose makers are locked in legal battle with the FDA.

Meanwhile, the e-cigs are starting to gain a pop-culture foothold – in the fall film “The Tourist,” actor Johnny Depp extols the devices’ virtues to Angelina Jolie, and Katherine Heigl showed up recently on the “Late Show with David Letterman” smoking the e-cigarette indoors. “Bet I’m freaking you all out right now, huh?” she asked the audience as she took a drag.

Manufacturers say electronic cigarettes, which deliver a spray of nicotine, do not fill lungs with tar, stain teeth or smell. They can deliver a heavy or light dose of nicotine, proponents say. They can be legally smoked indoors in public venues. Some argue they might be used as an alternative to the patch or nicotine gum as a way to quit smoking altogether.

But issues abound, according to this Healthy Skeptic column. No one yet knows if e-cigarettes are more or less effective than, say, gums or patches, because they haven’t been independently scientifically tested for this, some experts say. And some studies show the electronic cigarettes don’t deliver any significant amount of nicotine to a person’s bloodstream.

In a Q&A, the Food and Drug Administration makes its concerns clear:

“When FDA conducted limited laboratory studies of certain samples, FDA found significant quality issues that indicate that quality control processes used to manufacture these products are substandard or non-existent. FDA found that cartridges labeled as containing no nicotine contained nicotine and that three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff.”

Meanwhile, even though the FDA has warned that many such cigarettes do contain dangerous chemicals, an appeals court recently ruled that the devices should be treated like other tobacco products.

I have no problem if they want to regulate the electronic cigarettes to protect the consumer from shoddy products, unhealthy ingredients that nobody might know about, and other things like that.

As long as they allow people to buy electronic cigarettes, and only work to protect the consumer and ensure the product is as described, I am good with that.

Go to Smokey Vapor to buy your electronic cigarettes.
Go to Smokey Vapor Updates for news and ratings of electronic cigarette companies and products.
Go to Soda Stream for more information about SodaStream products.

The Chicago Independent Press is reporting that Walmart has pulled electronic cigarettes from their shelves. People who want to buy electronic cigarettes will no longer be able to walk into the smoking section of their local Walmart and buy electronic cigarettes.

For thousands of Americans, electronic cigarettes (or e-cigs as they are sometimes called) have been a “miracle” that has helped them quit smoking, or, at the very least, drastically reduced it. But not everyone is a fan of electronic cigarettes and lawmakers in New York are hurriedly attempting to ban the sale of them in the state. Hearing the anti-electronic cigarette news from state lawmakers across the country, retail giant Walmart has backed away from the sale of the controversial items.

“They offered a smokeless solutions kit but now it’s gone,” says Rachel Johnson. Rachel has using electronic cigarettes for two years and she claims she has never felt better. “I don’t know what the problem is, it’s harmless and there have been no studies showing otherwise. I think the congress in New York just don’t understand it. If it’s new, it’s bad according to them.”

Walmart was rumored to carry electronic cigarettes and store them in the smoking section behind one of the checkout aisles. It’s the same place traditional smokes are kept and sale of the devices would be to those over the age of 18.

“I was excited over it. I thought, ‘Man, if Walmart is behind it, then there’s no stopping it. Millions will be saved.’” says Johnson. “But they’re cowards. I guess they’ll go back to selling NASCAR pants and huge bags of cheese snacks.”

If legislation is passed in New York, the state would be the first to ban electronic cigarettes until the FDA can study the device to make sure it’s not a health risk. Pundits expect the bill to be passed in the state house. It will go to the Republican-controlled Senate afterward. New York GOP members have been mum on the issue.

“If I can quit without e-cigarettes, then anybody can do it,” says New York Assemblywoman Linda Rosenthal, a Democrat.

Linda Rosenthal is out of her mind if she thinks that just because she was able to quit using one method that that should be fine for everybody else as well. Some people react differently to different methods, others like and enjoy different methods and take to them better or worse, and some things just work differently on different people.

It is a shame that Walmart will not be carrying them. This would have opened the market, and many people would have been exposed to buy electronic cigarettes and made the move away from what is clearly bad to what is better – tobacco to ecigs.

The best line in the article is this, “I was excited over it. I thought, ‘Man, if Walmart is behind it, then there’s no stopping it. Millions will be saved.’” says Johnson. “But they’re cowards. I guess they’ll go back to selling NASCAR pants and huge bags of cheese snacks.”

How true.

Go to Smokey Vapor to buy your electronic cigarettes.
Go to Smokey Vapor Updates for news and ratings of electronic cigarette companies and products.
Go to Soda Stream for more information about SodaStream products.

This week has been a busy week for electronic cigarette litigation, and, in my opinion, a successful week for the people who buy electronic cigarettes.

The FDA has been trying to get the ability to regular electronic cigarettes as a drug or medical device, but the courts have so far rejected the FDAs petitions saying they cannot be regulated as such, but can be regulated as tobacco products. After the FDA lost the court case, the FDA decided to appeal the decision, taking the case to the US Circuit Court of Appeals.

This week the Court of Appeals heard the case, and they too rejected the FDA.

Here is the report from CSP Daily News:

This week, the U.S. Circuit Court of Appeals for the District of Columbia ruled that the full court will not review a three-judge panel’s decision, issued in early December. That panel’s decision was that electronic cigarettes cannot be regulated by the FDA as a drug or medical device, but can be regulated as a tobacco product by the FDA–provided the manufacturer refrains from marketing the product as having therapeutic purposes.

The lawsuit issue considered last year by the three-judge panel was whether the FDA could regulate electronic cigarettes under the drug and device provisions of the Federal Food, Drug and Comestic Act (FDCA) or as tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) passed in 2009.

In this litigation, the FDA had argued that electronic cigarettes are drug or medical devices under the FDCA, which require approval from the agency–similar to approvals given to nicotine gum and nicotine patch products. However, the three judge panel determined that electronic-cigarette manufacturers had not made therapeutic claims and, for that reason, the products could not be regulated under the drug and device provisions of the FDCA.

With the full U.S. Circuit Court of Appeals deciding not to review the three-judge panel’s decision, the FDA has the option of requesting the U.S. Supreme Court to hear the case. Media reports indicate that the FDA is considering its legal and regulatory options.

Personally I think this is good news. And I think they would be silly to take the case to the Supreme Court. They can only do this because they are playing with other people’s money.

They should already see it as obvious that the courts are protecting the people and see the situation as it should be seen – these are, at worst, tobacco devices (and even then only because of the nicotine). They really should be independently tested, and , assuming they pass the testing process, approved as a smoking cessation device, or a smoking alternative.

Go to Smokey Vapor to buy your electronic cigarettes.
Go to Smokey Vapor Updates for news and ratings of electronic cigarette companies and products.
Go to Soda Stream for more information about SodaStream products.

ABC News ran a report today about electronic cigarettes, the lack of regulation, and how people are using them, often successfully, to help themselves quit smoking even though they are not regulated for that purpose.

ABC News says:
New York is pushing to become the first state to ban the devices, which so far remain unregulated and mostly unstudied. With cutesy colors, fruity flavors, clever designs and other options, e-cigarettes may hold too much appeal for young people, critics warn, offering an easy gateway to nicotine addiction.

But those criticisms clash with equally strong arguments for the value of e-cigarettes. The devices, which are tobacco-free, may be a safer alternative to cigarettes, say advocates, who point to testimonials from thousands of smokers who say they have used e-cigarettes to help them quit.

As the U.S. Food and Drug Administration struggles to gain regulatory control, and as safety studies remain works in progress, the debate continues.

“There really are a lot of unknowns with respect to health,” said Prue Talbot, a toxicologist at the University California, Riverside. “I don’t know of any studies in the literature which are peer-reviewed. Almost all of the studies have been paid for by the e-cigarette companies.

E-Cigarettes Sold As Safe, Which Is Probably Not True, Says Toxicologist ”E-cigarettes are often sold as safe, which is probably not true,” Talbot added. “They may not be as dangerous as real cigarettes, but on the other hand, they could be. We just don’t know.”

Electronic cigarettes typically use a rechargeable battery-operated heating element to vaporize the nicotine in a replaceable cartridge. Nicotine is usually dissolved in propylene glycol, a clear and colorless liquid that is commonly found in inhalers, cough medicines and other products.

Some e-cigarettes are made to look like real cigarettes, cigars or pipes. Others look like pens or USB memory devices. There is no tobacco involved, and no smoke either. Instead, users do what’s called “vaping.” As they inhale, they take in nicotine-filled vapor.

By isolating nicotine, e-cigarettes should carry far fewer chemical risks than regular cigarettes, said Michael Siegel, a tobacco researcher at Boston University. Tobacco contains about 5,000 known chemicals, he said, with as many as 100,000 more that haven’t yet been identified. E-cigarettes eliminate many of those ingredients.

Siegel and a colleague reviewed 16 studies that analyzed the contents of electronic cigarettes. In a paper just published in the Journal of Public Health Policy, they reported that levels of certain harmful chemicals were on par with levels found in nicotine patches and hundreds of times lower than what’s found in cigarettes.

The researchers also found evidence that vaping reduces cravings among smokers, not just for nicotine but also for the need to hold something in their hands and put something in their mouths — making the devices more appealing to them than patches or gum.

As a cigarette-quitting strategy, Siegel compared e-cigarettes to heroin needle exchange programs. It’s not that the devices are good for anyone, he said. They are just better than what they’re meant to replace.

“The relevant question is not, ‘Are these things safe?’” he said. “But are these things much safer than real cigarettes, and do they help people quit smoking? The answer to both of those questions we know is yes.”

“What New York is doing is equivalent to outlawing lifeboats on a sinking ship because they haven’t been FDA approved,” he added. “It’s a really crazy approach to public health.”
[...]

As ABC says, despite the lack of anybody’s legal ability to say that electronic cigarettes are frequently used to help quit smoking, the fact is that that is probably the most common usage of the electronic cigarettes, and a very large majority of such uses are satisfied with the results.

Go to Smokey Vapor to buy your electronic cigarettes.
Go to Smokey Vapor Updates for news and ratings of electronic cigarette companies and products.
Go to Soda Stream for more information about SodaStream products.

The FDA has been saying that the ingredients in electronic cigarettes are too unknown and have not been researched enough to determine whether or not ecigs are safer than cigarettes or not.

Because of that, the electronic cigarette companies and people who promote them are not allowed to make any ecig health claims.

Engadget points to a new study by Boston University’s School of Public Health that says otherwise.

They say:
researchers at Boston University’s School of Public Health has found that not only are e-cigarettes much safer to “smoke” than normal ones, they may also aid in kicking the addictive habit altogether. According to the researchers, “few, if any” of the chemicals found in e-cigarettes pose serious health risks, and carcinogen levels in them are up to 1,000 times lower than in actual tobacco

That’s an amazing study and validation of the industry. One day the FDA will see the light as well and promote smoking electronic cigarettes as an alternative to tobacco cigarettes.

Go to Smokey Vapor to buy your electronic cigarettes.
Go to Smokey Vapor Updates for news and ratings of electronic cigarette companies and products.
Go to Soda Stream for more information about SodaStream products.