Well rarely do I post news stories but this one has some HUGE implications to us as it will make it far easier to get this done now in canada. FDA is no longer going to be calling ecig a drug delivery device, what this means is that it will be far easier to exist as a retailer because the drug rules were basically impossible to meet. Here is the link http://www.mercurynews.com/business/ci_17924024?nclick_check=1
BIIIGGGG news, FDA is basically ending the fight with ecigs!
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blu cigs? Haven't heard of them before.. checked their webpage... images of half naked women, customer "testimonials" and their "special edition Swarovski crystal starter kits"
I agree with Healy that the shady dealers need to be rooted out.
I agree with Healy that the shady dealers need to be rooted out.
Didn't expect that at all but it is indeed great news.
Now I wonder, if it is regulated the same as tobacco products will vaping indoors in public be a thing of the past?
Now I wonder, if it is regulated the same as tobacco products will vaping indoors in public be a thing of the past?
Well, the FDA has no say over how State laws define "smoking." Each State would have to redefine the law to specifically include vaping.
I don't think I am allowed to post links so here's more info. copied and pasted.
Regulation of E-Cigarettes and Other Tobacco Products
April 25, 2011
Dear Stakeholder:
The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.
The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.
Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.
Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.
Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”
FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.
Sincerely,
Lawrence R. Deyton, M.S.P.H., M.D.
Director
Center for Tobacco Products
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Regulation of E-Cigarettes and Other Tobacco Products
April 25, 2011
Dear Stakeholder:
The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.
The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.
Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.
Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.
Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”
FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.
Sincerely,
Lawrence R. Deyton, M.S.P.H., M.D.
Director
Center for Tobacco Products
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Would appreciate comment on this.
“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
When the crack down started here I was really suspicious that big pharma had started manufacturing e-cigs and e-juice.Get rid of all the little guys and move in for the big profits.I guess time will tell.
this is a bunch of legalized mumbo jumbo... i suspect that there's something hidden in there that will let them screw us over... seems too easy!
The question now is - where does it leave Canada? Will they follow suit with something of their own closely related to the FDA? Or are they still going to push their "advisory" to the bitter end.
That's what I would like to know.
That's what I would like to know.
Dude! This is fantastic news! Now, in the US, e-cigs will be classified with the same regs as pipe tobacco,
snuff and cigars! A drug delivery device classification would have been a disaster.
I think the tide has finally turned down south. It doesn't mean that their fight is over, but momentum is now on our side.
It won't be long before the herd animals in HC have to change, too. It now all makes sense (that they would try to bring the hammer down now), they probably saw the writing on the wall long before we did.
Its melatonin all over again, if you ask me.
snuff and cigars! A drug delivery device classification would have been a disaster.
I think the tide has finally turned down south. It doesn't mean that their fight is over, but momentum is now on our side.
It won't be long before the herd animals in HC have to change, too. It now all makes sense (that they would try to bring the hammer down now), they probably saw the writing on the wall long before we did.
Its melatonin all over again, if you ask me.
I sure hope this will make things better for us in Canada. Thanks for putting this info up!!
The FDA not appealing to the Supreme Court is huge. They have no options left but to go with regulating as tobacco products. They can't re-initiate to the Supreme Court as far as I know, it was their one chance (maybe this assuming on my part).
But given the happiness of the response from vaping suppliers in the US that started the law suit and other suppliers down there this can only be a good thing all around for vapers.
But given the happiness of the response from vaping suppliers in the US that started the law suit and other suppliers down there this can only be a good thing all around for vapers.
Good news indeed. My beliefs as spoken 1 year ago is that all the posturing was to gain time to set up regulations in order to control manufacturing and tax the product, which will come. It is a given. The downside of controlling the product, nicotine content restrictions as well as flavours. I seriously doubt that we will see any high yield nicotine liquid (if any) be available for DIY, and not to mention saying goodbye to our tuity fruity mixes.
Good news to vapers sad news to vendors at least on the liquid level. They have to date, from what I see, no intention to control devices (good news) OTOH regulations will force small time vendors out of business under the enforcement of Bill C-36 (in Canada) anyway. The later of course are for those that have not applied for "market authorization", which in itself is no easy feat to acquire not to mention very expensive. IOW very few vendors can meet the recurring financial obligation of selling liquids.
Good news to vapers sad news to vendors at least on the liquid level. They have to date, from what I see, no intention to control devices (good news) OTOH regulations will force small time vendors out of business under the enforcement of Bill C-36 (in Canada) anyway. The later of course are for those that have not applied for "market authorization", which in itself is no easy feat to acquire not to mention very expensive. IOW very few vendors can meet the recurring financial obligation of selling liquids.
I think, if the same things happen in Canada, it will be no more ordering from the states. I don't think your allowed to buy cigarettes through the mail, so this would then be the same thing.
And Higher prices, don't forget how much tobacco tax we pay.
And Higher prices, don't forget how much tobacco tax we pay.
... true. But on the other hand we were only fooling ourselves to think that we could/would vape unregulated. The government want's their cut and they will get it. The other two monkeys of this particular threesome want their profits as well.
I just want to say that I respectfully disagree with nearly everything in this post. Nothing personal, but I feel very strongly that Canadian vapers reading this thread should not be unduly discouraged by unfounded pessimism.
It is not a given at all that vaping will ever be taxed at all, apart from regular sales tax (or in our case, HST). There is no basis for sin-taxing vaping whatsoever. Alcohol & tobacco-cigarettes are proven to burden society; conversely, vaping does not burden society in the least. If anything, it benefits society. Sin-taxing vaping would be the equivalent of sin-taxing coffe: it isn't going to happen, because it's nonsensical.
A sin-tax would also just open the doors to a burgeoning contraband market. Rest assured, if anyone is ever idiotic enough to propose such, we'll fight it. But I don't see any such proposal getting wings; if they could sin-tax coffe (which could be viewed as a drug-delivery device or drug-delivery product), they would have done it by now. After all, there's a potential fortune to be made right there!
So why haven't they? Because it would be nonsense. Caffeine may be an addictive drug, but it does not burden society. You see: in the real world, money does not & cannot trump all, as just demonstrated in the above example. And lo & behold...vaping e-juice with nicotine via e-cigs has already conclusively proven to be no more harmful than drinking caffeinated coffe. So there.
Really, what would the government say? "Ah, um...we want to tax vaping prohibitively...because, uh...vaping...kills people??" Do you not see how ludicrous that would be?
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And what's this about an end to DIY & tutti-fruity mixes? Tobacco, NRT & e-liquid all contain comparable levels of the exact same nicotine. There is no valid basis for allowing those levels of nicotine in tobacco & NRT, but denying it in e-liquid, based on...what? The whim of some schmuck at HC? Let's get real here. Furthermore, on what grounds could the Canadian government ever outlaw the purchase of concentrated flavourings? Obviously, they can't. Even in the worst possible outcomes, DIY will always remain a safe harbour for vapers.
I realize conspiracy theorists & pessimists have built a large part of their worldview around expecting the worst, against all reality. But sensible people, please pay them no mind. Critical thinking is your friend.
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Moving right along...there is nothing to indicate that small-time vendors will be forced out of business, now or ever. Vendors are not manufacturers; it is not their responsibility to apply for market authorization. They are the middlemen, not the creators. Furthermore...
No e-cig or e-juice manufacturer will ever waste time or money submitting their products to Health Canada for testing as a "health product," since their products aren't health products, make no therapeutic claims, and therefore could not possibly be approved by Health Canada as "health products" in a million years.
By simple virtue of the fact that these products make no therapeutic claims, they are not health products. That alone is all HC needs to say "not approved as a health product."
That's the real point here - no one can possibly receive market authorization from HC under these bogus conditions, because the premise is false from the beginning.
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E-cigs & e-juice with nic are not pharmaceuticals, and the ridiculously expensive requirement for them to be tested as such is unlawful. The FDA won't be able to require manufacturers to submit to that stupid sort of false testing anymore...and we intend to put an end to it here, too.
HC's market authorization process right now is unlawful. It is designed to unlawfully ban perfectly legal products. It is a fraudulent process, & we're going to take it down. So the next time someone gets it into their head that the costs of legitimate market authorization are going to drive anyone out of business - that's nonsense. Once we have a legitimate process in place (which we don't have right now), things will be fine.
The legitimate process will not be designed to bankrupt those who apply for market authorization - it will in fact be far cheaper than the testing-as-a-pharmaceutical costs...and this process will not be filled with impossible standards that are designed to effectively ban these products, either.
And if you're just a middleman, a supplier who has nothing to do with the manufacturing of the products you sell...even better. You won't be responsible for submitting Dekang liquid etc to HC - Dekang will be.
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It is incredibly great news that the FDA has admitted final defeat in the States. Such will only make the optics of our case against HC that much stronger & clearer. HC has zero chance of winning the class-action suit we will bring against them (knock on wood) - and after that, their remaining options are going to be extremely limited.
So this is not a time for pessimism - it is a time for celebration & encouragement as we press forward to victory in Canada with more vigour than ever before, in the fresh afterglow of America's victory. We don't just seek victory...we demand it. We claim it!!!
Keep on vaping, friends - we're in it to win it!!!
I still think this needs to go to court before HC will budge. And God help us all if it's labeled a drug delivery system. Need a prescription to get overpriced, flavorless, 100% PG, low concentration nic juice... 
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