Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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hasn't the FDA repeatedly said that they dont do their own studies and testing and that it is the responsibility of manufacturers to do that for them? How is it now , that they seem to be able to pull studies out of thin air............among other places.
Since Obama got Pharma to get off its hard line and consider giving us peons a tiny break....might the e-cig railroad be the cost?
Yes, that is the case. The problem is with FDA position on e-cigarettes. The type of testing they want is unwarranted and basically prohibits us from getting the approval. Their stance is "new drug/device combo", that means years of clinical trials and millions of dollars.
The alternative is to view analogs, patches, gum, inhalers and/or combination as similar (which they are) and that would allow for a quick/inexpensive approval.
They do not do studies for application and approval---but that is not to say they do not do studies on products that are floating around out there like the e-cig that are unapproved and contend that they need to go though the approval process.
Sun
I wonder how many studies have be done by the FDA on things like Relicore.
for what it's worth, the FDA is completely corrupt. i have major lower-back issues. 3 degenerative discs, 2 of which are herniated and will not heal due to the degeneration. the only surgery to "fix" this problem available to me in the USA is to remove the discs and fuse the vertebrae together, limiting mobility. 2 of 5 persons who have this surgery must have at least one more surgery later in life. i am NOT willing to take that chance.
in Europe, they have a few different surgeries that i have read about. first, they have a prosthetic disc that they replace the degenerative disc with. the second surgery available that has shown good results, is using monkey discs to replace the human disc. neither of these surgeries are available in the USA. wonder why? well, the FDA will not approve them. the FDA is run by the drug companies. if they fix my back, i no longer have to get a $990 prescription (before insurance), monthly. how much money would they lose if they fixed all the people with similar issues as i? plenty. this is just another example of the drug companies running the FDA. they want to be the ONLY suppliers of "smoking cessation" devices. that's why Nicorette or any other gum, inhaler, or anything else that uses nicotine costs a RIDICULOUS amount of money. $50 for less than a months worth of patches or gum? come on. you can't tell me that they aren't making a killing on those products. now, with the prescription "smoking cessastion" drugs, it's even worse. they can get insurance money for that! we are screwed, i'm unfortunately convinced. STOCK UP!!!
in Europe, they have a few different surgeries that i have read about. first, they have a prosthetic disc that they replace the degenerative disc with. the second surgery available that has shown good results, is using monkey discs to replace the human disc. neither of these surgeries are available in the USA. wonder why? well, the FDA will not approve them. the FDA is run by the drug companies. if they fix my back, i no longer have to get a $990 prescription (before insurance), monthly. how much money would they lose if they fixed all the people with similar issues as i? plenty. this is just another example of the drug companies running the FDA. they want to be the ONLY suppliers of "smoking cessation" devices. that's why Nicorette or any other gum, inhaler, or anything else that uses nicotine costs a RIDICULOUS amount of money. $50 for less than a months worth of patches or gum? come on. you can't tell me that they aren't making a killing on those products. now, with the prescription "smoking cessastion" drugs, it's even worse. they can get insurance money for that! we are screwed, i'm unfortunately convinced. STOCK UP!!!
What surprises me is that the new tobacco bill would have anything to do with this case considering it wasn't even passed until after the fact. I thought the courts usually ruled according to the laws in effect at the time...
Careful--the parties are bound by any new caselaw or legislation that is passed before a final judgment is entered. As a matter of fact, the parties are bound to apprise the Court of any new cases or laws that affect their case, be it for or against their position. So this new legislation is definitely in play to the extent that it now is is law.
Sun
Even with that being the case, I wonder if there could be some of the ruling in SE's favor...
Lone---where the nicotine comes from does not make it a tobacco product--The holding in Brown only protects traditional tobacco products like cigarettes and cigars---The Reason? The holding in Brown was that tobacco products are already deemed to be so hazardous that there is no way to make them safe and regulate them other then to ban them outright. This is not the case with the e-cig and nicotine ( we hope) --So the holding in Brown will not afford the e-cig the santity of protection for the very reason we all want to vape!!! The e-cig can be found to be reasonably safe --hence it can be regulated by the FDA.
Sun
I didn't see this and don't have time to sort through it all so I am posting this here and now but if it is duplicated or in the wrong place I apologize and feel free to move or delete
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
E-Cigarettes Pose a Health Hazard, FDA Warns
Thu Jul 23, 4:04 PM PDT
- WEDNESDAY, July 22 (HealthDay News) -- Testing of electronic cigarettes, known as e-cigarettes, has shown that they contain cancer-causing chemicals and other toxins, including a compound used in antifreeze, U.S. health officials said Wednesday.
E-cigarettes are battery-operated devices that contain cartridges filled with nicotine, flavorings and other chemicals. "The device turns nicotine, which is highly addictive, into a vapor that is inhaled," according to the U.S. Food and Drug Administration.
And these products could encourage smoking, the agency warned.
Dr. Joshua Sharfstein, FDA's principal deputy commissioner, said in a news conference Wednesday that "public health experts, including the World Health Organization, the U.S. Centers for Disease Control and Prevention and the American Cancer Society, have expressed concerns about the safety of these products and the risk that electronic cigarettes may increase nicotine addiction among young people and ultimately lead kids to try conventional cigarettes."
The FDA analyzed the ingredients in a small sample of cartridges from two brands of electronic cigarettes marketed by U.S. companies: NJOY, of Scottsdale, Ariz., and Florida-based Smoking Everywhere, according to Benjamin Westenberger, deputy director of the pharmaceutical analysis division at the Center for Drug Evaluation and Research, part of the FDA.
Although e-cigarettes are sold in the United States, they are manufactured overseas, mostly in China.
In one sample, analyses detected diethylene glycol, an antifreeze component. In several other samples, analysts found carcinogens, including nitrosamines, Westenberger noted.
"All of these results indicate an overall lack of quality control," he said. "These results indicate that these e-cigarettes could have safety and quality concerns."
The American Lung Association said that it supports the FDA's concerns. "For too long, e-cigarette manufacturers have sold these nicotine delivery devices -- absent FDA review and approval," the association said in a statement Wednesday. "These findings indicate FDA is serious about enforcing the law to protect consumers from unapproved products."
The lung association statement said that the group "urges the FDA to act immediately to halt the sale and distribution of all e-cigarettes unless the products have been reviewed and approved for sale by the FDA."
In addition to the testing, the FDA said it has been examining and detaining shipments of e-cigarettes at the border. So far, 50 shipments have been seized, according to Michael Levy, division director of the Office of Compliance at the Center for Drug Evaluation and Research.
But the battle over whether e-cigarettes are legal is just getting starting. The FDA contends that e-cigarettes are both a drug and a device, making them subject to U.S. government regulation under the Federal Food, Drug and Cosmetic Act. However, one of the companies that markets e-cigarettes, Smoking Everywhere, filed suit against the FDA in late April, claiming that the agency overstepped its authority by banning shipments and insisting that e-cigarettes go through the drug approval process, FDA officials said during the news conference.
A big concern of health experts is that e-cigarettes are marketed and sold to young people. The devices are available online and in shopping malls and could be a gateway to smoking actual cigarettes, they noted.
"It looks like a cigarette, and it's used like a cigarette," Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics' tobacco consortium, said during the news conference. "It's marketed as a cigarette, and thus has the potential to normalize and cue smoking behavior."
Winickoff noted that cartridges for e-cigarettes are available in flavors, including chocolate, mint and bubblegum. "Past experience suggests that these products may be particularly appealing to young people," he said.
"E-cigarettes might encourage children, preteens and young adults to take their first step toward smoking cigarettes," he said.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
E-Cigarettes Pose a Health Hazard, FDA Warns
Thu Jul 23, 4:04 PM PDT
- WEDNESDAY, July 22 (HealthDay News) -- Testing of electronic cigarettes, known as e-cigarettes, has shown that they contain cancer-causing chemicals and other toxins, including a compound used in antifreeze, U.S. health officials said Wednesday.
E-cigarettes are battery-operated devices that contain cartridges filled with nicotine, flavorings and other chemicals. "The device turns nicotine, which is highly addictive, into a vapor that is inhaled," according to the U.S. Food and Drug Administration.
And these products could encourage smoking, the agency warned.
Dr. Joshua Sharfstein, FDA's principal deputy commissioner, said in a news conference Wednesday that "public health experts, including the World Health Organization, the U.S. Centers for Disease Control and Prevention and the American Cancer Society, have expressed concerns about the safety of these products and the risk that electronic cigarettes may increase nicotine addiction among young people and ultimately lead kids to try conventional cigarettes."
The FDA analyzed the ingredients in a small sample of cartridges from two brands of electronic cigarettes marketed by U.S. companies: NJOY, of Scottsdale, Ariz., and Florida-based Smoking Everywhere, according to Benjamin Westenberger, deputy director of the pharmaceutical analysis division at the Center for Drug Evaluation and Research, part of the FDA.
Although e-cigarettes are sold in the United States, they are manufactured overseas, mostly in China.
In one sample, analyses detected diethylene glycol, an antifreeze component. In several other samples, analysts found carcinogens, including nitrosamines, Westenberger noted.
"All of these results indicate an overall lack of quality control," he said. "These results indicate that these e-cigarettes could have safety and quality concerns."
The American Lung Association said that it supports the FDA's concerns. "For too long, e-cigarette manufacturers have sold these nicotine delivery devices -- absent FDA review and approval," the association said in a statement Wednesday. "These findings indicate FDA is serious about enforcing the law to protect consumers from unapproved products."
The lung association statement said that the group "urges the FDA to act immediately to halt the sale and distribution of all e-cigarettes unless the products have been reviewed and approved for sale by the FDA."
In addition to the testing, the FDA said it has been examining and detaining shipments of e-cigarettes at the border. So far, 50 shipments have been seized, according to Michael Levy, division director of the Office of Compliance at the Center for Drug Evaluation and Research.
But the battle over whether e-cigarettes are legal is just getting starting. The FDA contends that e-cigarettes are both a drug and a device, making them subject to U.S. government regulation under the Federal Food, Drug and Cosmetic Act. However, one of the companies that markets e-cigarettes, Smoking Everywhere, filed suit against the FDA in late April, claiming that the agency overstepped its authority by banning shipments and insisting that e-cigarettes go through the drug approval process, FDA officials said during the news conference.
A big concern of health experts is that e-cigarettes are marketed and sold to young people. The devices are available online and in shopping malls and could be a gateway to smoking actual cigarettes, they noted.
"It looks like a cigarette, and it's used like a cigarette," Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics' tobacco consortium, said during the news conference. "It's marketed as a cigarette, and thus has the potential to normalize and cue smoking behavior."
Winickoff noted that cartridges for e-cigarettes are available in flavors, including chocolate, mint and bubblegum. "Past experience suggests that these products may be particularly appealing to young people," he said.
"E-cigarettes might encourage children, preteens and young adults to take their first step toward smoking cigarettes," he said.
Jann -
It's true! (Well, sort of.) I posted about it here:
http://www.e-cigarette-forum.com/fo...-regarding-fda-press-release-7-22-repost.html
This should help you understand what they're saying, and take the fear element out of their statement.
-Nate
It's true! (Well, sort of.) I posted about it here:
http://www.e-cigarette-forum.com/fo...-regarding-fda-press-release-7-22-repost.html
This should help you understand what they're saying, and take the fear element out of their statement.
-Nate
Judge Leon ordered another hearing because we filed supplemental briefs on the new law. The issue of whether an electronic cigarette is a "tobacco product" is covered by Brown and is bound up by the concept of intended use. To keep it simple, intended use to be a non-therapeutic "device" to deliver nicotine (aka a "cigarette") equals a tobacco product. Intended use to deliver therapeutic nicotine to wean someone off of nicotine all together (aka "smoking cessation") equals a drug. It is really quite simple. FDA can't regulate a "tobacco product" like a "drug" because a "tobacco product" does not and con not prove a therapeutic endpoint. A "drug" requires pre-market approval for the therapeutic claim made by the manufacturer based on proof of both safety and efficacy. If anyone still wishes to go gain approval as a "drug" for an electronic cigarette they can - simply devise an adequate and well controlled clinical trial to prove that the product ultimately results in cessation of its use.
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