Deeming Regulations have been released!!!!

[beckdg]

That is what makes me so mad. They pass these things like the Patriot act without reading it. And how about Obamacare? Pelosi said they had to pass it to know what's in it. They need to do their effing jobs.

She said that after it was filibustered and revised.

Regardless, Nancy's obviously a little ......ed and doesn't know it.

How else could she plead such a case?

We have people in office in this country that don't know where babies come from.

That's NOT an issue of popular vote. It's an issue of maybe not having a better option.

Candidate A; 78 I.Q.

Candidate B; Bielzebub

Go ahead, pull the lever.

Tapatyped

 

[beckdg]

And people think Edward Snowden is a criminal. If you haven't seen his interview with John Oliver it's worth checking out. Very funny and very sad.

Last Week Tonight Snowden interview

He's a freaking hero!

Tapatyped

 

[salemgold]

Here is an interesting read.

FDA Kingpin Charged with Racketeering

 

[beckdg]

Here is an interesting read.

FDA Kingpin Charged with Racketeering

I was stoked when I saw that the first time.

Tapatyped

 

[salemgold]

I was stoked when I saw that the first time.

Tapatyped

Me too! Been reading everything that I am able to find on it. About time.

 

[drum747]

Sent this to my Senator, the format is screwed up because its through the link on the website where you type in the little taxpayer funded window and not regular email:

I am writing to express my deepest disappointment in your support for the FDA's so called "Deeming regulations" with regard to the life saving technology of vaping products. I smoked for 30 years and tried everything on the market in order to quit and failed until September 11th 2010, my daughters 2nd birthday. Feeling the devastating effects of smoking for 30 years, more and more each day, I knew I had to quit for my daughters sake as well as mine but nothing had worked (patches, gum, wellbuterin, etc.), I discovered vaping, still in its infancy mind you, not the great devices on the market today which will essentially be banned due to the PMTA costs under the "Deeming". I quit that day and have been vaping for almost 6 years now and all my smoking related symptoms went away, I can breath again! Vaping literally saved my life. I am not suggesting reasonable labeling and laws prohibiting sales to minors not be implemented, all vapers that I know (helped 5 other people quit tobacco myself) seem to support that idea but this is essentially a defacto prohibition and cannot be allowed to stand,

I have to say I do find it ironic that this is being pushed at a time when tobacco use has fallen drastically in this country, make no mistake, thats because of vaping and I suspect that is why this is happening now as the big tobacco and big pharma companies see the writing on the wall and lack of profits will not be allowed to go unchallenged,

Are you aware of the Royal College of Physicians statement on vaping that just came out?
Nicotine without smoke: Tobacco harm reduction

Here are some highlights:

- Vaping holds less than a 5% risk to the vaper

- NO harm to bystanders.

- More than 95% safer compared to smoking cigarettes,

- Is not a gateway to smoking but rather a gateway from smoking,

- Does not renormalize smoking but helps reduce allure of smoking,

- Electronic nicotine delivery systems (ENDS) should be encouraged for smokers to help quit

This video might help:
It’s Just the Science – Royal College of Physicians’ John Britton Talks e-Cigarette Benefits & Regulation (RegWatch Exclusive)

This is the oldest institution of physicians in the world and the first to link cigarettes with cancer in 1962.

I find the "save the children" angle frankly ridiculous, perhaps "save big tobacco" or "save big pharma" might be a more honest approach since they will be the only ones who can afford the $500K plus fee for each item through the PMTA process. These "regulations" are a gift to big tobacco and big pharma and nothing more.

In closing, you must know that supporting this massive overreach is absurd and a detriment to public health so at a minimum I would expect you to support HR2058 and/or the Cole-Bishop Amendment to reduce the negative impact on availability of products and ultimately peoples health, including mine.

Thank you for your time,

 

[bnrkwest]

Sent this to my Senator, the format is screwed up because its through the link on the website where you type in the little taxpayer funded window and not regular email:

I am writing to express my deepest disappointment in your support for the FDA's so called "Deeming regulations" with regard to the life saving technology of vaping products. I smoked for 30 years and tried everything on the market in order to quit and failed until September 11th 2010, my daughters 2nd birthday. Feeling the devastating effects of smoking for 30 years, more and more each day, I knew I had to quit for my daughters sake as well as mine but nothing had worked (patches, gum, wellbuterin, etc.), I discovered vaping, still in its infancy mind you, not the great devices on the market today which will essentially be banned due to the PMTA costs under the "Deeming". I quit that day and have been vaping for 6 years now and all my smoking related symptoms went away, I can breath again! Vaping literally saved my life. I am not suggesting reasonable labeling and laws prohibiting sales to minors not be implemented, all vapers that I know (helped 5 other people quit tobacco myself) seem to support that idea but this is essentially a defacto prohibition and cannot be allowed to stand,

I have to say I do find it ironic that this is being pushed at a time when tobacco use has fallen drastically in this country, make no mistake, thats because of vaping and I suspect that is why this is happening now as the big tobacco and big pharma companies see the writing on the wall and lack of profits will not be allowed to go unchallenged,

Are you aware of the Royal College of Physicians statement on vaping that just came out?
Nicotine without smoke: Tobacco harm reduction

Here are some highlights:

- Vaping holds less than a 5% risk to the vaper

- NO harm to bystanders.

- More than 95% safer compared to smoking cigarettes,

- Is not a gateway to smoking but rather a gateway from smoking,

- Does not renormalize smoking but helps reduce allure of smoking,

- Electronic nicotine delivery systems (ENDS) should be encouraged for smokers to help quit

This video might help:
It’s Just the Science – Royal College of Physicians’ John Britton Talks e-Cigarette Benefits & Regulation (RegWatch Exclusive)

This is the oldest institution of physicians in the world and the first to link cigarettes with cancer in 1962.

I find the "save the children" angle frankly ridiculous, perhaps "save big tobacco" or "save big pharma" might be a more honest approach since they will be the only ones who can afford the $500K plus fee for each item through the PMTA process. These "regulations" are a gift to big tobacco and big pharma and nothing more.

In closing, you must know that supporting this massive overreach is ridiculous and a detriment to public health so at a minimum I would expect you to support HR2058 and/or the Cole-Bishop Amendment to reduce the negative impact on availability of products and ultimately peoples health including mine.

Thank you for your time,

 

[beckdg]

And people think Edward Snowden is a criminal. If you haven't seen his interview with John Oliver it's worth checking out. Very funny and very sad.

Last Week Tonight Snowden interview

[emoji23]

Drumpf



Tapatyped

 

[Vandal]

Hey vapers the tax man is coming

"Government actions show clearly public health and a smoke-free society are not the goals. If they were very little regulation and oversight would be needed and vaping would be promoted as a possible breakthrough toward achieving a smoke-free society, just as it is being promoted in the UK. The US is working hard to make vaping more expensive, harder to innovate, and doing so while crushing big tobacco’s mom and pop competitors. We are witnesses to the fact US politicians, bureaucrats, lobbyists, and their associated PACs simply want the money more than wanting people to be healthy.

"Vapers need to know the regulating administration will insure vapers pay the tax man. He is coming and the US government does not mind twisting any truth, restricting your liberty and charging you extra for the privilege."

 

[The Ocelot]

More pondering...

This is from the FFD&C Act in 1996 final rule when the FDA got authority over tobacco products. At the time, the FDA asserted jurisdiction to regulate tobacco products, concluding that, under the FDCA, nicotine is a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body.

“…for the many individuals who have become addicted, their capacity to choose whether to use cigarettes or smokeless tobacco in large measure no longer exists. Thus, the agency must take their addiction into consideration when developing its regulatory scheme.

"Serious health consequences follow both from the option of leaving tobacco products on the market and from the option of banning tobacco products. However, on balance, an approach that prohibits the sale and promotion of cigarettes and smokeless tobacco to children and adolescents, while permitting the sale to adults seems most appropriate.

"It is consistent with the statutory standard of reasonable assurance of safety and is more effective in achieving public health goals than a ban on all tobacco products. Therefore, FDA is adopting this approach in this final rule.

"There is also a basis for finding that these products are 'effective' for adults who are addicted to tobacco products because such products sustain with great efficacy the individual’s continued need for the active ingredient nicotine. Tobacco products are effective for preventing withdrawal symptoms in individuals addicted to nicotine in much the same way that methadone is effective in preventing withdrawal."

Now remember, they were writing about cigarettes!

The FDA's authority was overruled in 2000.

Then in 2009 the FSP&TC Act gave authority over tobacco back to the FDA, but this time it was under the guise of smoking. BTW, the final rule of the act is actually called "FDA Final Rule Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco." Don't ask how long it took me to figure that out.

"The Food and Drug Administration (FDA) is reissuing a final rule restricting the sale, distribution, and use of cigarettes and smokeless tobacco. As required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), FDA is issuing a final rule that is identical to the provisions of the final rule on cigarettes and smokeless tobacco published by FDA in 1996, with certain required exceptions."

The "required exceptions" basically have to do with prior language regarding cigarettes as drug delivery systems, etc. I couldn't find any reference to adult addition in the 2009 document. I think that means the 1996 description stands or the FDA just redlined through several pages.

The reason I think it might still stand, is in a 2010 CRS Report Prepared for Members and Committees of Congress on the "FDA Final Rule Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco" the report refers to a statement in the 1996 Act.

"The agency said that the purpose of the rule was to reduce the easy access to tobacco products by minors. It also hoped to reduce the amount of positive advertising imagery used by manufacturers to make their products appealing to minors.

"While the rule did not directly address adult tobacco use, FDA argued that over time it would help reduce adult tobacco consumption. Data from the National Survey on Drug Use and Health indicate that the vast majority of smokers take up the habit as teenagers. Thus, reducing the number of new teenage smokers, who were needed to replace adult smokers who quit or die, was expected to lower overall tobacco consumption in the future."

Doesn't that make you feel warm and fuzzy?

So now we get to the Deeming regs of 2016.

Adult addiction isn't addressed. And below is the only time "withdrawal" appears not in context of adolescents:

"(Comment 152) Some comments stated that e-cigarettes should be subject to little or no FDA regulation, because e-cigarettes inhibit withdrawal symptoms in users with a history of relapse (Ref. 191)…”

"(Response) FDA disagrees. Although ENDS may potentially provide cessation benefits to individual smokers, no ENDS have been approved as effective cessation aids. If an ENDS manufacturer wishes to make a cessation claim, the company must submit an application for their ENDS to be marketed as a medical product."

"FDA also notes that many comments from the ENDS industry emphasized the potential public health benefits of these products in their comments on the NPRM.

"For example, numerous industry comments argued that restrictions on access to the newly deemed products would be detrimental to public health, as the products may be less toxic than conventional cigarettes and may be successfully used as a cessation product.

"FDA's consideration of public health benefits of products will be included in FDA's review of PMTAs based on the evidence."

Great. The FDA will consider public health benefits when reviewing PMTAs, but apparently not before.

(This will be edited as I find spelling and grammar errors.)

 

[HazyShades]

Hey vapers the tax man is coming

"Government actions show clearly public health and a smoke-free society are not the goals. If they were very little regulation and oversight would be needed and vaping would be promoted as a possible breakthrough toward achieving a smoke-free society, just as it is being promoted in the UK. The US is working hard to make vaping more expensive, harder to innovate, and doing so while crushing big tobacco’s mom and pop competitors. We are witnesses to the fact US politicians, bureaucrats, lobbyists, and their associated PACs simply want the money more than wanting people to be healthy.

"Vapers need to know the regulating administration will insure vapers pay the tax man. He is coming and the US government does not mind twisting any truth, restricting your liberty and charging you extra for the privilege."

EXACTLY.
Vaping will exist, only it is going to be much more expensive.
Think of a pack of ciggies that costs 5 or 6 bucks in the US
but only a dollar in Jamaica or S. America.
Apply it to vaping.
Its all about tax dollars and extracting/extorting billions from the vape industry.

 

[Vandal]

EXACTLY.
Vaping will exist, only it is going to be much more expensive.
Think of a pack of ciggies that costs 5 or 6 bucks in the US
but only a dollar in Jamaica or S. America.
Apply it to vaping.
Its all about tax dollars and extracting/extorting billions from the vape industry.

If they succeed in crushing the vaping industry, there won't be anything to extract.

 

[The Ocelot]

She said that after it was filibustered and revised.

Regardless, Nancy's obviously a little ......ed and doesn't know it.

Are you familiar with the Dunning–Kruger effect?

 

[lauragal]

EXACTLY.
Vaping will exist, only it is going to be much more expensive.
Think of a pack of ciggies that costs 5 or 6 bucks in the US
but only a dollar in Jamaica or S. America.
Apply it to vaping.
Its all about tax dollars and extracting/extorting billions from the vape industry.

At least $12 bucks a pack here in the Big Apple.

 

[lauragal]

If they succeed in crushing the vaping industry, there won't be anything to extract.

Bingo!

 

[HazyShades]

If they succeed in crushing the vaping industry, there won't be anything to extract.

True, but they'll extract it from BT and from all the vape
vendors/makers who file those forms to get approval.
It really is all about money. Understood that as in other things
fanatics will interfere and its a cause for them, but the gub'min is in it for the money.

 

[The Ocelot]

Here is an interesting read.

FDA Kingpin Charged with Racketeering

I'm happy that Hamburg's conflict of interest is being brought to light, but I wouldn't get too excited about the proceedings. It's not criminal case.



ETA: I didn't mean to post the complaint, it just did it. Also, regarding the article you linked to: while the author is certainly passionate, he could do with some fact-checking.

 

[HazyShades]

At least $12 bucks a pack here in the Big Apple.

Hi Lauragal! Long time no see.
Wow, that is expensive. All for taxes...

Regards,
Hazy

 

[HazyShades]

I'm happy that Hamburg's conflict of interest is being brought to light, I wouldn't get too excited about the proceedings. It's not criminal case.

Not yet. Those are pretty serious accusations/claims

 

[crxess]

Hey vapers the tax man is coming

This just Landed on Campaign for Tobacco-Free Kids FB Page