FDA Has anyone consider this:

[hoogie76]

Firstly, I realize that this is draft regulations.. But I'll continue with my comments.

Effective Dates--The deeming provisions and age restrictions would be effective 30 days
from the date of publication of the final rule. The proposed health warning requirements would
be effective 24 months after the final rule is issued. In addition, manufacturers could continue to 14
introduce into domestic commerce existing inventory that may not contain the warning
statements required under the final rule for an additional 30 days after the health warnings take
effect.

According to this, despite all the other fluff in the proposed regulations, once e-cigs are deemed to be tobacco, the deeming provisions as described later in the doc could be applied within 30 days of approval of the regulations. I see nothing that stops them from doing this despite non committing chat/emails about not doing this. Also even just section 906(d) of the FD&C Act, which is referred to many times in the proposed regs, gives the authority to ban any product the secretary sees fit as not having public health benefits. There is also a provision in 906(d) defining a deadline for the FDA to define how non face to face sales are handled. In looking further into this, the FDA has chosen not to meet the deadline for defining non face to face sales as it feels the need for this has been trumped by the PACT Act. When reading further into this, once deemed a tobacco product, the PACT Act could automatically apply to e-cigs which would make online sales difficult. In essence, online sales could go away automatically without the FDA having to even mention it.

Just some other random thoughts that I've noticed and have been recognized by others is the cherry picking of references the FDA has provided. There is not a single positive reference.

I feel hardware is going to be difficult because of not only it's acceptance as e-cig components but it's acceptance for 'other' products as well, plus the ability for just about anyone to build one. Other than structure changes in the heating element, the rest of the devices stays the same. This would have to apply to all markets and in my opinion be difficult to enforce.

One other thought: We have over 7+ years of data regarding e-cig use and health affects/ surveys, etc.. Why not shoot for one of the many other types of regulations as described here:

Is It Really FDA Approved? 

thanks for reading.. hoog.

 

[Kryyptyk]

I feel hardware is going to be difficult because of not only it's acceptance as e-cig components but it's acceptance for 'other' products as well, plus the ability for just about anyone to build one. Other than structure changes in the heating element, the rest of the devices stays the same. This would have to apply to all markets and in my opinion be difficult to enforce.

The FDA doesn't have the authority to regulate mechanical parts as drugs, only as medicinal delivery devices. Since the overturn of the ruling in 2009, the FDA can't regulate vaping hardware as medicinal delivery devices. The closest that they can get, legally, is regulating vaping hardware the same as a tobacco pipe. Pipes are widely available, and have much looser restrictions than tobacco itself.

Just like pipes, anyone can make a mod. So FDA authority in the matter of vaping hardware was already diminished, before these proposals were even drafted. Since they consider their authority to be unsatisfactory, the FDA has opted to try to change the rules of the game. What you are seeing here with these deeming proposals is the FDA attempting to rewrite the definition of 'tobacco product', to cover e-liquid and vaping hardware. It's our job to make sure they don't succeed.

 

[salemgold]

It was decided in federal court back in 2011 that ecigs and ejuice are classified as unregulated tobacco products. So, it is not the FDA rewriting any rules in that regard.

http://www.e-cigarette-forum.com/fo...e-njoy-vs-fda-discussion-211.html#post3086105

 

[Kryyptyk]

It was decided in federal court back in 2011 that ecigs and ejuice are classified as unregulated tobacco products. So, it is not the FDA rewriting any rules in that regard.

http://www.e-cigarette-forum.com/fo...e-njoy-vs-fda-discussion-211.html#post3086105

There is a major difference between a court ruling and a federal regulation. This is the FDA's attempt at making the 'tobacco product' label stick, by formally affixing the verbiage of the definition, as laid out in the Family Smoking Prevention Tobacco Control Act, to electronic cigarettes and their components. This is changing the 'rules of the game' by allowing something that is clearly not tobacco to be regulated alongside and as tobacco.

Electronic cigarettes, nicotine patches, nicotine gum, and others are what is referred to as "NRTs", or Nicotine Replacement Therapies. Patches and gum are used by millions of smokers to attempt to quit, yet they are still considered 'regulated tobacco products' under the Supreme Court ruling. Conversely electronic cigarettes have also been used by millions of smokers to quit, quite successfully, and are still being ruled as unable to make claims to smoking cessation, first by the Supreme Court ruling, and now by these damnable regulations.

The only real differences between electronic cigarettes and the others is that: 1. Electronic cigarettes haven't been granted official NRT status, and 2. Electronic cigarettes actually work. FDA knows this and is actively working to prevent electronic cigarettes from being formally approved as an NRT, in the interests of BP. This is what is referred to as 'regulatory capture'. Many United States regulatory agencies have been proven corrupt before, so this shouldn't come as a surprise.

 

[Maestro]

The FDA has admitted they don't have authority over juice with no nicotine in it. By extension that should also include devices for that juice.

 

[Stubby]

The FDA doesn't have the authority to regulate mechanical parts as drugs, only as medicinal delivery devices. Since the overturn of the ruling in 2009, the FDA can't regulate vaping hardware as medicinal delivery devices. The closest that they can get, legally, is regulating vaping hardware the same as a tobacco pipe. Pipes are widely available, and have much looser restrictions than tobacco itself.

The FDA has not as of yet deemed pipe tobacco and it is not covered in the original tobacco act of 2009. Pipes are yet not under FDA authority (along with pipe tobacco).

Contrary to what a few people are saying the FDA most certainly will regulate vaping hardware.

There is a major difference between a court ruling and a federal regulation. This is the FDA's attempt at making the 'tobacco product' label stick, by formally affixing the verbiage of the definition, as laid out in the Family Smoking Prevention Tobacco Control Act, to electronic cigarettes and their components. This is changing the 'rules of the game' by allowing something that is clearly not tobacco to be regulated alongside and as tobacco.

Electronic cigarettes, nicotine patches, nicotine gum, and others are what is referred to as "NRTs", or Nicotine Replacement Therapies. Patches and gum are used by millions of smokers to attempt to quit, yet they are still considered 'unregulated tobacco products' under the Supreme Court ruling. Conversely electronic cigarettes have also been used by millions of smokers to quit, quite successfully, and are still being ruled as unable to make claims to smoking cessation, first by the Supreme Court ruling, and now by these damnable regulations.

The only real differences between electronic cigarettes and the others is that: 1. Electronic cigarettes haven't been granted official NRT status, and 2. Electronic cigarettes actually work. FDA knows this and is actively working to prevent electronic cigarettes from being formally approved as an NRT, in the interests of BP. This is what is referred to as 'regulatory capture'. Many United States regulatory agencies have been proven corrupt before, so this shouldn't come as a surprise. :closed eyes:

NRT's are not considered an unregulated tobacco product. They are regulated as a drug. The reason for that is intended use. The intent of NRT is the quit smoking (actually quit all nicotine). They have gone through the clinical trials and have been approved by the FDA as a quit smoking drug. Electronic cigarettes are not regulated as a drug because their intent is as a recreational tobacco product, same as cigarettes, cigars, smokeless tobacco, etc. Some people may use electronic cigarettes as a tool to quit all nicotine by stepping down (same idea as NRT), but that is not their intended use. You can rant about the silliness of it all day but it's wasted energy, When it comes to the law intent is nearly everything.

 

[Stubby]

The PACT act does not make it illegal to ship tobacco, but it does make it illegal for the USPS to ship cigarettes and smokeless tobacco. They can still be shipped by UPS or any other non-government carrier. I am all to familiar with the PACT act as I get snus shipped from Sweden and the shipping cost for international UPS is not cheap.

There are other provisions of the PACT act. Packages need to be verified on delivery with an adult signature with a picture ID. Also taxes need to be paid by the vender for any state taxes. That means that if 50 states have different tax rates (and that is the case with smokeless tobacco) the vender has to pay that tax to each state for any products sold to the state. Some states have laws that make it illegal to ship any tobacco product to a resident of that State. My own state of Wisconsin is one of those. I actually have to get my snus shipped directly from Sweden as any domestic venders cannot ship to Wisconsin.

Having said all of that my understanding of the PACT act is that it only applies to smokeless tobacco and cigarettes. It would have to be amended to include electronic cigarettes. But I wouldn't want to be quoted on that as I am not at all sure.

 

[grandmato5]

The PACT act does not make it illegal to ship tobacco, but it does make it illegal for the USPS to ship cigarettes and smokeless tobacco. They can still be shipped by UPS or any other non-government carrier. I am all to familiar with the PACT act as I get snus shipped from Sweden and the shipping cost for international UPS is not cheap.

There are other provisions of the PACT act. Packages need to be verified on delivery with an adult signature with a picture ID. Also taxes need to be paid by the vender for any state taxes. That means that if 50 states have different tax rates (and that is the case with smokeless tobacco) the vender has to pay that tax to each state for any products sold to the state. Some states have laws that make it illegal to ship any tobacco product to a resident of that State. My own state of Wisconsin is one of those. I actually have to get my snus shipped directly from Sweden as any domestic venders cannot ship to Wisconsin.

Having said all of that my understanding of the PACT act is that it only applies to smokeless tobacco and cigarettes. It would have to be amended to include electronic cigarettes. But I wouldn't want to be quoted on that as I am not at all sure.

I agree, based on the research I could find, it does appear that that PACT act would have to be amended to include ecigs as they would not be covered under the definition used for "cigarettes' or "smokeless tobacco" within the current PACT act. So unless the PACT act was amended deeming ecigs as a tobacco product would not automatically place then under the PACT act

 

[Kryyptyk]

The FDA has not as of yet deemed pipe tobacco and it is not covered in the original tobacco act of 2009. Pipes are yet not under FDA authority (along with pipe tobacco).

I am aware of this. I was speaking of the restrictions of pipe tobacco and pipes, not 'regulations'. Most places will still only sell these products to adults 18 and older, regulated or not, but they are widely available.

Contrary to what a few people are saying the FDA most certainly will regulate vaping hardware.

Funny, most people are saying it will be regulated. What remains to be seen is how stringent these regulations will be.

NRT's are not considered an unregulated tobacco product. They are regulated as a drug. The reason for that is intended use. The intent of NRT is the quit smoking (actually quit all nicotine). They have gone through the clinical trials and have been approved by the FDA as a quit smoking drug. Electronic cigarettes are not regulated as a drug because their intent is as a recreational tobacco product, same as cigarettes, cigars, smokeless tobacco, etc. Some people may use electronic cigarettes as a tool to quit all nicotine by stepping down (same idea as NRT), but that is not their intended use. You can rant about the silliness of it all day but it's wasted energy, When it comes to the law intent is nearly everything.

1.) I quite clearly stated that NRTs are classified as tobacco products under the Supreme Court ruling. They may be marketed as medical devices, but they are still considered a tobacco product.

2.) NRTs don't have anywhere close to a success rate to justify their status as a smoking cessation aid. NRT users have a quit rate as low as 15% after a year of use. Anyone who has used conventional NRTs can attest to this. Conversely, electronic cigarettes have more success testimonials than any smoking cessation aid in history. Independent surveys have placed the success rate to as high as 85%.

3. The FDA attempted to regulate electronic cigarettes as medicinal delivery devices before they attempted to regulate them as tobacco products. This shows that electronic cigarettes were considered as possible NRTs before the Supreme Court ruling. The electronic cigarette was quite clearly created as a means to quit smoking, as the man who made the first model did so to help his father stop smoking. The only reason the 'intent' of electronic cigarettes was altered was to provide a means to dodge the blanket ban made by the FDA in 2009.

 

[Padre]

2.) NRTs don't have anywhere close to a success rate to justify their status as a smoking cessation aid. NRT users have a quit rate as low as 15% after a year of use. Anyone who has used conventional NRTs can attest to this. Conversely, electronic cigarettes have more success testimonials than any smoking cessation aid in history. Independent surveys have placed the success rate to as high as 85%.

3. The FDA attempted to regulate electronic cigarettes as medicinal delivery devices before they attempted to regulate them as tobacco products. This shows that electronic cigarettes were considered as possible NRTs before the Supreme Court ruling. The electronic cigarette was quite clearly created as a means to quit smoking, as the man who made the first model did so to help his father stop smoking. The only reason the 'intent' of electronic cigarettes was altered was to provide a means to dodge the blanket ban made by the FDA in 2009.

I am trying to wrap my head around some of these numbers, can you please clarify?

I have attempted using these numbers in the past and questions came up I was unable to answer

the 15% that quit with NRT, is that 15% of the people that used NRT to quit are now no longer using anything with nicotine, they have completely stopped using any type of device that provides nicotine?

is that the same scenario with electronic cigarettes?, 85 % of users now no longer take in nicotine?

my guess is 15% using conventional NRT now don't smoke, and 85% using e cigarettes don't smoke!

I think the FDA will try to play with those numbers so they are compared the same, what percentage are now not using any nicotine delivery at all