OMG - eCigs may not be as harmful as tobacco analogs!! This from the home of RJ Renolds

[DC2]

So to regulate e-cigarettes (or any other product meeting the definition), the Secretary (of Health and Human Services) needs to issue a regulation that "deems" that product to henceforth be covered by the tobacco Act.

And to clarify a bit more, these "deeming regulations" are what the FDA intends to propose in October.

 

[hanzo.esq]

Here's the JAMA article, in case you're looking for a bit of light reading: JAMA Network | JAMA | The Regulatory Challenge of Electronic Cigarettes

This is an outstanding article with a very fair and informed overview of ecigs. It's punchline is that ecigs are safer than smoking, but we just can't be sure b/c there are so many people making them w/o any oversight.

Regulation is coming. If it is based on articles like that, then I am reassured.

Hanzo.

 

[Petrodus]

Yeah ...
We won't feel safe until "Mommie FDA" regulates e-cigs.

 

[sbdivemaster]

Thanks for the info. I can see the points on medicinal use. You've opened my eyes a bit. It just seems so complicated. They bit*ch because we smoke, then they bit*ch because we want to quit. They are never happy until they have controlled us.

Take a look at my sig line...

Just need to add one point about regulation as a tobacco product.

The law specifically covers only traditional tobacco cigarettes, chewing tobacco, and roll-your-owns. So anything that meets the definition if NOT automatically covered by the Act. The law has this to say on the subject:

So to regulate e-cigarettes (or any other product meeting the definition), the Secretary (of Health and Human Services) needs to issue a regulation that "deems" that product to henceforth be covered by the Tobacco Act.

What this means is that currently e-cigarettes are not regulated as either a medicine or a tobacco product.

So, is it possible that a future HHS Director could deem PV's are NOT a tobacco product? And all regulations go poof...? PV's go back to not regulated as either a medicine or a tobacco product?

 

[Vocalek]

This is an outstanding article with a very fair and informed overview of ecigs. It's punchline is that ecigs are safer than smoking, but we just can't be sure b/c there are so many people making them w/o any oversight.

Regulation is coming. If it is based on articles like that, then I am reassured.

Hanzo.

See Response #41 and tell us what you think. http://www.e-cigarette-forum.com/forum/legislation-news/438222-what-vapers-want-5.html

 

[Vocalek]

Take a look at my sig line...



So, is it possible that a future HHS Director could deem PV's are NOT a tobacco product? And all regulations go poof...? PV's go back to not regulated as either a medicine or a tobacco product?

There is no way to deem a product to be "not covered." Any tobacco product not named in the act itself, or not designated in the future to be deemed a product regulated under the tobacco act, is not covered automatically.

Nothing is forcing the Secretary to deem e-cigarettes to be covered, but there is a lot of political pressure for her to do so. So that is something that you can expect to come to pass.

There is also nothing stopping an e-cigarette company from jumping through the hoops to get their product approved by the Center for Drug Evaluation and Research (CDER) as a smoking cessation treatment (i.e., a pharmaceutical product). Well, except for the billions of dollars needed and for the time and expertise required to complete all the necessary testing. Meanwhile, the company could continue to market its product, but without making any health claims.

So it is conceivable that in the public there can be two versions of a product that are identical, with one version marketed with health claims (regulated by CDER), and the other marketed without health claims (regulated by the Office of Tobacco Products.)

 

[sbdivemaster]

I'm still confused.

Are you saying that once any Sec.HHS deems PV's are covered by the Tobacco Act, that's it? It's set in stone forever?

If the power to deem PV's are covered by the Tobacco Act rests with the Sec.HHS, and the current Secretary does so, what's to stop a future Sec.HHS from deeming PV's are NOT covered by the Tobacco Act?

I'm not trying to be argumentative, just trying to understand the legislation. (Correct me if I am wrong, but is this covered under Sec. 901(a) and (b) of the TCA?)

 

[NorthOfAtlanta]

I'm still confused.

Are you saying that once any Sec.HHS deems PV's are covered by the Tobacco Act, that's it? It's set in stone forever?

If the power to deem PV's are covered by the Tobacco Act rests with the Sec.HHS, and the current Secretary does so, what's to stop a future Sec.HHS from deeming PV's are NOT covered by the Tobacco Act?

I'm not trying to be argumentative, just trying to understand the legislation. (Correct me if I am wrong, but is this covered under Sec. 901(a) and (b) of the TCA?)

Much easier to prevent a regulation than attempt to get bureaucrats to give up power later.

 

[Orb Skewer]

I'm still confused.

Are you saying that once any Sec.HHS deems PV's are covered by the Tobacco Act, that's it? It's set in stone forever?

If the power to deem PV's are covered by the Tobacco Act rests with the Sec.HHS, and the current Secretary does so, what's to stop a future Sec.HHS from deeming PV's are NOT covered by the Tobacco Act?

I'm not trying to be argumentative, just trying to understand the legislation. (Correct me if I am wrong, but is this covered under Sec. 901(a) and (b) of the TCA?)

Forget about the 'PV's - they are a blerdy torch with high power batteries in, and a screw connection-anyone with a lathe can churn them out FFS
It's the Liquid (its availability and strength) that is the achilles heel

 

[alexrho]

Exactly we must comment in positive articles or in negative with the truth and of course with evidences

 

[Vocalek]

I'm still confused.

Are you saying that once any Sec.HHS deems PV's are covered by the Tobacco Act, that's it? It's set in stone forever?

If the power to deem PV's are covered by the Tobacco Act rests with the Sec.HHS, and the current Secretary does so, what's to stop a future Sec.HHS from deeming PV's are NOT covered by the Tobacco Act?

I'm not trying to be argumentative, just trying to understand the legislation. (Correct me if I am wrong, but is this covered under Sec. 901(a) and (b) of the TCA?)

Yes. 901(a) and (b) of the TCA are what controls FDA authority over products.

‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

‘(a) In General- Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 911, shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V.

‘(b) Applicability- This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.

According to several online dictionaries, "undeemed" is not a word. It seems that the Center of Medicare and Medicaid Services has decided that it is a word.

When talking about eligibility of Medicare recipients for extra help in meeting Medicare Part D (prescription drug coverage), officials stated, "Individuals who lose their LIS eligibility effective January 1, 2012, because they no longer automatically qualify for extra help, have a Special Enrollment Period (SEP) beginning January 1, 2012, through March 31, 2012."

Rather than referring to the letters sent to the Medicare recipient as notices of ineligibility, they decided to call them them "undeemed letters."

As mentioned above, CMS will be reporting to Part D plan sponsors those members who are being notified about their loss of LIS deemed status. Part D sponsors will receive two files containing one record for each affected beneficiary. The first will be sent in September and will include those members who will be receiving CMS’ grey “undeemed” letter.

Either they are using colorful language, or the CMS plans to print the letters on grey paper.

http://www.healthlawyers.org/Member...randa/July 2011/2012LIS undeemed-20110726.pdf

To answer the first part of your question, I suppose it is possible that the Secretary of Health and Human Services could issue a regulation that rescinds the authority of the Office of Tobacco Products over a previously deemed product. And they might even title it an "undeeming" regulation. However, I'd give the odds of that ever happening <1%.