Archive for 'fda'

The Alphabet Soup of Federal Governmental Stakeholders

For the e-cigarette community, knowing the governmental stakeholders, along with the missions of each stakeholder, can provide a basic insight into the complexities of governmental intervention.

FdaBy getting an understanding about some of these stakeholders, the e-cigarette community can better understand not only the obstacles which the e-cigarette industry must overcome but also identify allies to help overcome or mitigate those obstacles.

Federal Governmental Agencies

Before going into each individual agency, the e-cigarette community can depend that, on the whole, these agencies fall into the obstacle category.

For the e-cigarette industry, the governmental stakeholders theoretically have unique missions, but, as with governmental entities, the actuality where one entity begins and another ends is so unclear that distinguishing which entity the e-cigarette falls under is, at best, described as convoluted.

Just as it began the attack on cigarettes, the Office of the Surgeon General will expand its anti-tobacco commitment to include the e-cigarette.

The Food and Drug Administration’s (FDA) mission, as stated by the head of the FDA in its “Strategic Priorities 2011-2015,” is to “protect and promote the public health.”  Under the assumption that “there is no known safe tobacco product,” the e-cigarette community has already won one big battle with the FDA.

To-date, use of the e-cigarette on commercial airlines has been at the discretion of the airline company.  According to recent information, the Department of Transportation will be issuing a regulation, going into effect in the spring 2012, prohibiting the use of the e-cigarette on all airlines.

Part of Alcohol, Tobacco, Firearms, and Explosives’ (ATF) mission is “to prevent criminal encroachment of the legitimate . . . tobacco industries organizations.” Basically, ATF is a law enforcement agency, not a policy making agency as is the FDA.  Consequently, in many ways the ATF protects the e-cigarette industry, as long as the taxes are paid.

For the e-cigarette industry, the Tobacco Tax and Trade Bureau (TTB), which is responsible for all inquiries in regards to regulating the . . . tobacco industries . . . and for the collection of taxes, seems to be one of those seldom referenced but possibly problematic governmental bureaus.  Depending on how TTB approaches is regulating ability; it can be either an ally or an obstacle for the e-cigarette manufacturer.

Another governmental entity that the e-cigarette community would probably readily name is the USDA (United States Department of Agriculture).  However, how many e-cigarette users would know the AHRQ (Agency for Healthcare Research and Quality), EPA (Environmental Protection Agency), FTC (Federal Trade Commission), HIS (Indian Health Service), OSHA (Occupational Safety and Health Administration), or SAMHSA (Substance Abuse and Mental Health Services Administration), just to name the most acknowledged.

Not To Be Overlooked

Nevertheless, the e-cigarette community must not forget to whom these governmental entities, and any other governmental entity that enters the e-cigarette discussion, depend; specifically, the USC (the United States Congress, both the Senate and the House of Representatives), the EB (Executive Branch, headed by the President), and the Judiciary.   While many of the e-cigarette community may consider these overseers as an obstacle, time has shown that pragmatism may prevail, especially where federal revenue is concerned.

The E Cigarette and The Powers That Be

First An Interesting Video About The E Cigarette And Rush Limbaugh! Interesting and a must see!

The E Cigarette and The Powers That Be: An Inside Look at The Pharma’s Views

e cigarette

When it comes to cigarette smoking, it has always been a double edged sword. On the one hand, people really enjoy smoking. On the other hand, it is addictive, bad for your health and can just plain kill you. Many people have spent untold amounts of time, effort, money and suffering trying to quit smoking. More often than not, their attempts to quit ended in failure. In the case of your noble author, i have tried to quit about 30 times over my 40 year smoking career. I even managed to quit for 2 years at one point but most of my attempts ended in failure after days or weeks.

Second in number, only to my attempts to quit smoking, have been the different ways i tried to quit. I’ve tried quitting cold turkey and by eating special diets. There were the nicotine patches and milder brands of cigarettes. I took prescription drugs that could cause potentially serious side effects. But despite my best efforts, I am still a smoker at almost 60 years of age. However, I recently saw some light at the end of the tunnel with my discovery of a new product to help me quit smoking tobacco.

The new product is the e cigarette, also know as the smokeless cigarette.

The e cigarette was invented by a Chinese health practitioner in 2003 and since then it has attracted quite a bit of attention and financial success. The e cigarette is a 2 part metal tube that looks like a real cigarette and gives you a measured dose of nicotine with each drag. The internal heating element vaporizes a small amount of the liquid nicotine into simulated smoke that gives you the sensation of inhaling. However, since nothing is burned, there are none of the toxic chemicals and smoke found in real tobacco cigarettes. To wrap it all in a nice, neat package, there is no second hand smoke to annoy non-smokers.

There has been a lot of good press and many articles have been written about the e cigarette. There has also been a large volume of anecdotal material and positive user comments about the e cigarette as a quit smoking device. Even doctors, who are horrified by smoking tobacco, have said it is considerably better to try to quit using the electronic cigarette than it is to continue smoking tobacco. No one has been injured or killed by e cigarettes and a substantial number of people have quit smoking using the device. Certainly no one has fallen asleep and burned themselves to a pile of ash using an e cigarette unlike the fate of many tobacco smokers who were foolish enough to smoke in bed.

This all brings us to one of America’s most “beloved” institutions, the FDA or Food And Drug Administration. This ubiquitous agency is known to insiders as “Big Pharma’s best friend” and as usual, they are working hard to keep the title. Take for example this recent nugget from the FDA dated April 25, 2011:

“The Food and Drug Administration announced Monday that it will act to ensure the government’s right to impose marketing, manufacturing and safety restrictions on “electronic cigarettes,” a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can’t light up.

In a letter posted to the FDA’s website Monday, Dr. Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.”

Once again the FDA has jumped head first into the fray, as they put it, “To protect the health of Americans of all ages.” One might wonder what their real motivation is and who will benefit the most from their draconian attempt to regulate e cigarettes. The FDA hasn’t been deterred in the least from this attempt to regulate smokeless cigarettes despite the “recent decision by the U.S. Court of Appeals for the D.C. Circuit in Sottera, Inc. v. Food & Drug Administration, stating that e-cigarettes and other products are not drugs/devices unless they are marketed for therapeutic purpose…”

On the one hand, we have a device that makes no medical claims but may actually help people quit smoking. This device has not caused anyone to die unlike tobacco cigarettes or many of the drugs the FDA has approved but the FDA is still on the warpath. Until they lost the court case, the FDA was seizing shipments of e cigarettes at U.S. Customs and trying to have the e cigarette banned permanently. Now they want them classified as if they were tobacco cigarettes. This move would force the manufacturers of e cigarettes to spend untold millions of dollars on FDA approved testing and development to be able to market electronic cigarettes. The FDA is simply trying to put the e cigarette out of business.

Another factor involved in the FDA’s efforts to regulate the e cigarette and classify them as tobacco is tax revenues. The government is terrified that the e cigarette may be as effective as they seem to be and millions of smokers will use the smokeless cigarette to quit smoking. This would cost the government untold billions in tobacco taxes. Unless of course, they can replace the tax revenues they would lose from tobacco cigarettes by taxing the e cigarette as if it were tobacco. All this from the government that claims it is only out to protect us from dangerous and fraudulent products. Another shining example of the the out of control, Federal government milking the tax payer for every cent they can wring out of us.

Then we have the major drug companies and their issues with the e cigarette. Just like vitamins, homeopathic medicines, herbal products and so many other things that the FDA has tired to control and regulate, the e cigarette is bad for the profit line of Big Pharma. The drug companies are not in the business of making you well. The sicker you get the more they make. They couldn’t give a hoot about your health or mine. This is an insidious network of government agencies and multi national corporations who will do everything in their power to crush any product they cant totally control, market and make a massive profit on. It’s no different than the FDA’s attempt to get vitamins classified as drugs because Big Pharma hasn’t been able to find a way to patent vitamins and thereby get an exclusive on their sale. These are people who would have air declared a drug if they thought they could get away with it.

An ugly fight is on the horizon but sadly most of the e cigarette manufacturers are small companies who don’t have the deep pockets to go up against the FDA. It looks like they will have to throw themselves on the mercy of the Federal Courts where they have had some limited success and hope for the best. Meanwhile, the FDA will do every dirty thing it can think of to put many e cigarette companies in dire straits. For the moment, I can still find an affordable supply of e cigarettes and extra nicotine cartridges at the local mall. I hope the FDA fails in their crusade against the e cigarette. As far as i am concerned, the e cigarette a damned sight safer and more effective then pills and nicotine patches.

Smokestik Electronic Cigarette Starter Kit

I created this video to show how to assemble the Smokestik Starter Kit. Enjoy! To purchase this, or learn more about our products please visit www.smokestikusa.com For exclusive discounts, please use coupon code: KTD Unlike traditional cigarettes, Smokestik does not contain all the harmful carcinogens found in traditional cigarettes that cause cancer and other health problems. After purchasing the start up kit, smoking the Smokestik ends up being CHEAPER than smoking a traditional cigarette! Now you can save money and your health! We are currently looking for others who would also like to distribute these wonderful products. Please message me if you would like to become a distributor as well.

 

There has actually been a lot of discussion recently about the most recent FDA Judgment By Judge Leon.

E cigarettes have one and the factor is qiute clear. Electronic Cigarettes are not tobacco or a measured substance it is not tobacco and as a result may not be taken into consideration uder the territory of the FDA.

Electronic cigarettes are managing the smoking world, exactly what with the cost being less and none of the linked wellness dangers of cigarette smoking hazardous tobacco. Its like a dream happened. I remeber where I was when I initially checked out a write-up regarding these outstanding little innovations … It has to have concerned 5 years ago. The expenses where a ton additional and due to that I thought personally that they would certainly never remove.

Now the electronic cigarette is a ton advanced, the modern technology is already developed and now the price is a ton even more economical.

E cigarette Information

Some fascinating videos on the e cigarette.

Right here we’re visiting be covering news updates, health updates, assessments and what the FDA are claiming about the e cigarette.

The very first one is rather an appealing message from a previous United States Congressman, who is presently the head of state of the American E cigarette Organization.

[youtube] http://www.youtube.com/watch?v=_d9S6USXR20 [/ youtube]

Enjoy, Kindly comment and enable me know your thoughts.

Simon

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