Tag Archive | "FDA"

Electronic Cigarettes and the FDA


Electronic cigarettes, the FDA, anti-freeze and teenagers… how are these four connected?

Apparently the FDA found small traces of diethylene glycol, an ingredient used in antifreeze, in one sample of electronic cigarette solution they analyzed. They are also concerned that teenagers will get addicted to electronic smoking. How serious are these issues? Are e-cigarettes harmful devices that should be banned? Lets get the facts straight and put all this information into perspective.

Diethylene glycol may be a toxic ingredient but exactly how toxic is it?

1. It is has one-tenth the toxicity of aspirin.
2. It has one-fortieth the toxicity of nicotine (the primary ingredient in electronic cigarette vapor).

Diethylene glycol is also found in everyday consumable products like:

- Toothpaste
- Mouthwash
- Cough syrup
- Wine
- Dog food
- And many others…

You have to wonder why the FDA is focusing so much on the minute traces of diethylene glycol found in one sample when clearly this is a very common ingredient many of us are ingesting regularly.

That’s not to say that diethylene glycol is totally harmless and we shouldn’t have any concerns about it. But when the FDA starts focusing on words like ‘diethylene glycol’ and ‘anti-freeze’ it sure does sound scary. However, a little bit of education on the facts puts it back in perspective doesn’t it? By the way, water is another ingredient found in anti-freeze!

The FDA tends to give the impression that they have regulatory control over nicotine. That is not always the case. They regulate smoking cessation products and claims. That’s why electronic cigarettes are marketed as a smoking alternative and not as a means to quit smoking.

Another “concern” expressed by the FDA is that electronic cigarettes target underage kids. Here is an FDA quote from one of their reports:

“These products are marketed and sold to young people and are readily available online and in shopping malls. They are also available in different flavors, such as chocolate and mint, which may appeal to young people”.

There is absolutely zero evidence that e-cigarettes target teenagers. Just the opposite… the marketing is focused on adults who already smoke and are searching for a healthier alternative they can use in public places. And here is some breaking news: Adults like to shop in malls and enjoy a variety of flavor choices too! Besides, the initial cost of entry for a top of the line electronic cigarette is not practical for most teenagers.

I encourage you to do your own due diligence and research the electronic cigarette to see if this is something that will benefit you. Look at all sides of the story and try to get unbiased information. Right now the FDA appears to be biased against electronic smoking for some reason. Do they have a hidden agenda? Who knows… but I think I detect trace elements of BS in the FDA reports!

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FDA Can’t Regulate ‘Electronic Cigarettes’


The Food and Drug Administration can’t block tobacco distributors from importing “electronic cigarettes” into the United States, a federal judge in Washington, D.C., ruled in a decision that could save at least one domestic distributor from going under.
U.S. District Judge Richard Leon rejected the FDA’s ban on importation, saying electronic cigarettes are regulated by the Tobacco Act, just like regular cigarettes.
The FDA detained more than 35 shipments headed for the distribution companies Smoking Everywhere and NJOY, saying the products qualified as drug-device combinations under the Food, Drug and Cosmetic Act. In the FDA’s view, the electronic cigarettes weren’t simply therapeutic; they also affected the structure or function of the body.
Judge Leon disagreed.
“[A]ll they purport to do is offer consumers the same recreational effects as a regular cigarette,” he wrote, calling the FDA’s argument “bootstrapping run amuk.”
Leon said the FDA’s rationale would force him to exclude traditional cigarettes from the list of acceptable tobacco products.
“Congress did not intend tobacco products to be drugs merely because they deliver nicotine,” Leon wrote.
Smoking Everywhere touts the product as an “alternative to traditional cigarettes that delivers the same sensation as smoking,” but “without combustion or the use of cancerous byproducts.” Electronic cigarettes vaporize liquid nicotine, allowing the user to inhale nicotine without the tar, carbon monoxide, ash and smell of traditional cigarettes, according to the ruling.
But they are not meant to affect the body in any way different from regular cigarettes, Leon wrote. And the companies never touted them as having therapeutic effects, such as treating nicotine addiction, the ruling states. Instead, the companies were promoting nicotine use by encouraging consumers to use the product as often as they would traditional cigarettes.
The court granted the distributors’ motion for a preliminary injunction blocking the enforcement of the FDA’s ban on the importation of electronic cigarettes.
Electronic cigarettes are the sole product line for Florida-based Smoking Everywhere, according to the ruling. The distributor’s inventory is “already near depletion,” and no domestic electronic cigarette makers exist. Smoking Everywhere has sold more than 600,000 electronic smoking kits since it began operating more than a year ago. Competitor NJOY has sold more than 135,000 since its opening in 2007.
Leon said the case demonstrates the FDA’s “drive to maximize its regulatory power” – another example of its “aggressive efforts to regulate recreational tobacco products as drugs or devices.”

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Prominent Tobacco Researchers Expose Double Standard in FDA’s Study of Electronic Cigarettes and Challenge FDA’s Alarmist Attitude Toward the Devices


electronicsigaret

The press release can be found here.

I have copied it below, as well:

Prominent Public Health Physicians and Tobacco Researchers Expose Double Standard in the FDA’s Recent Study of Electronic Cigarettes and Challenge the FDA’s Alarmist Attitude Toward the Devices

Contact: Thomas R. Kiklas, Director of Media, inLife LLC, 949-250-9600 ext 108,
tkiklas@myinlife.com

BOSTON, July 27 /Standard Newswire/ — The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential.

A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA has based its warning against electronic cigarettes. They are concerned that the FDA’s disingenuous targeting of electronic cigarettes through a biased presentation of the scientific data has had significant negative impact upon the public perception of electronic cigarettes, when the best available evidence suggests that these have shown that the devices offer great potential to reduce serious health issues among traditional tobacco smokers.

In a July 22 news release, the FDA cited the detectable presence of carcinogens and “toxic chemicals” in a “small sample” of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco.

Regrettably, the FDA has used biased reporting of this small and inconclusive study, the complete results of which have not been made public, to secure the vocal support of groups such as the American Academy of Pediatrics Tobacco Consortium, the Institute for Global Health, and the American Lung Association in their attack on electronic cigarettes. These researchers argue that it is absurd to consider taking electronic cigarettes off the market when it is the conventional ones which have been shown to be killing people. Further, the electronic cigarette community calls for accurate and fair reporting relative to the findings and statements of prominent medical professionals in favor of this new and important technology and challenges the media to tell the other side of the story.

“The FDA’s laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes,” says Dr. Michael Siegel. “The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: ‘Are electronic cigarettes safe?’ That is not the right question. The right question is: ‘Are electronic cigarettes much safer than traditional ones?’”

Dr. Rodu states, “The FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and the methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years. These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes.”

Dr. Joel Nitzkin speaking as individual states, “The newly adopted FDA/Tobacco legislation will give full FDA approval to currently marketed conventional cigarettes. The new law encourages cigarette companies to produce new “reduced exposure” cigarettes to be marketed as reduced exposure products, with no scientific evidence that such reductions in exposure will reduce risk of future tobacco related illness and death. In the context of these provisions of the newly adopted FDA/Tobacco bill — FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

For more information and interviews, contact:

Michael Siegel, MD, MPH
Professor
Department of Community Health Sciences
Boston University School of Public Health
617-638-5167

Joel L. Nitzkin, MD, MPH, DPA
Chair AAPHP Tobacco Control Task Force
Phone: 504 899 7893 or 800 598 2561
Fax: 504 899 7557

Brad Rodu
Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville
Phone: 502-561-7273

Thomas R. Kiklas
Director of Media
inLife LLC
Phone: 949-250-9600 x108

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