Tobacco or Drug no difference to FDA

[trying]

Given the guidelines of the FDA's tobacco Advisory Committee I do not see how being a tobacco product is better than being a drug,

Tobacco Products Scientific Advisory Committee

The advisory committee will apply FDA standards to all testing they will require of new tobacco products and where will they get the guidelines for such testing. From the established FDA drug test requirements.

It might be a Tobacco Advisory board but they still answer to FDA and they think like the FDA so why should we expect different from the FDA ?

 

[sailorman]

I think standards are a bit different than protocols.
Maybe I'm wrong but I can't fathom that a new tobacco product would have to go through the years of clinical trials required of a new drug. Plus, I think big tobacco is slightly less predatory than big pharma in regards to their pricing strategies. If analogs were put under the control of pharma, a pack would cost $50. BT has to consider market share and the impact of taxing on their prices. If you deduct all taxes and account for inflation, analogs aren't really much more expensive than they were years ago.

At least if BT controls e-cigs, $1.50 of your $2 cartridge would come back in the form of tax revenue.
If BP runs things, it would be a $5 cartridge, $4.80 of which would be profit and the corporate tax paid by BP corps. (like most big corps.) is negligible.

As for myself, I'll be going underground either way.

 

[PlanetScribbles]

What makes me laugh the most is that anyone would think we were vaping arsenic and cyanide, such is the furore over e-cigs. When, in fact, the only way to inhale something approaching the dangers of the aforementioned is to buy a pack of completely legal Marlboros
Just so long as you pay the gatekeeper your , you can kill yourself any damn way you please. Just don't try to get away with self preservation by switching to a safer, untaxed, alternative

 

[Bill Godshall]

Perhaps trying can present some evidence to verify his/her claim in the title of this thread, explain how this posting is a "news" item worthy of a new thread, and explain why he/she believes that it would be no better (for e-cigarette marketers and consumers) if the FDA promulgated regulations for e-cigarettes as tobacco products under the FSPTCA than if FDA banned all sales of e-cigarettes (as unapproved drug devices) nationwide.

Clearly, the FDA, CTFK, ACS, AHA, ALA, ASH, Legacy and other e-cigarette prohibitionists disagree with trying's title and assertions, which is why the agency continues to insist the products are unapproved drug devices (and not tobacco products).

Although the TPSAC includes members who have been paid by drug companies to oppose tobacco harm reduction products and policies, their conflicts of interest are under increasing criticism and scrutiny, and they have no scientific or empirical evidence to justify imposing excessive regulations on e-cigarettes.

If/when the FDA wisely decides to promulgate regulations for e-cigarettes as tobacco products, the FDA will urge TPSAC to cooperate. Besides the FSPTCA requires the FDA (and the TPSAC) to rely on scientific evidence to justify any new tobacco regulations.

Seems like trying actually wants the FDA to ban e-cigarettes, and is just trying to cause divisiveness among e-cigarette consumers and vendors.

 

[BCB]

I don't think Trying is attempting to cause divisiveness. I think he's just new to the issue and doesn't understand the ramifications of the two choices. He seems to have an appropriate lack of trust in the FDA. I remember when there was much discussion on this forum about which choice would be most harmful to vapers, then it seems that a consensus was reached that "tobacco product" was our best bet. It's a crap shoot either way, since we can only guess what taxation strategy will be forged if they become a "tobacco product" and what parts will be taxed (juice, batteries, atomizers, cartos, etc.) Just sayin'....

(you're right, probably shouldn't have been in the "news" section of the forum, but moderators will probably move it soon--these errors happen)

 

[trying]

My posting was in reaction to the FDA publication of the October 7th meeting of the Tobacco advisory commmittee.
It appeared natural to put it here.
The point is that at the moment the E-cigarette industry only knows it does not want to be a regulated drug product,
but at the same time no one knows exactly what is required to be an approved tobacco product.
Even the FDA does not know the exact steps that will be required.
I suggested that without clear guidance FDA will rely on the guidelines it knows best, it's own.

 

[Kate51]

trying, it would be more heavily and more stringently regulated as a drug.
The FDA right now has the regulation of tobacco products, but cannot mandate removal of nicotine. This is the crux we are trying to explain here. We use nicotine. It is very precariously on a proverbial fence.

 

[Vocalek]

My posting was in reaction to the FDA publication of the October 7th meeting of the Tobacco advisory commmittee.
It appeared natural to put it here.
The point is that at the moment the E-cigarette industry only knows it does not want to be a regulated drug product,
but at the same time no one knows exactly what is required to be an approved tobacco product.
Even the FDA does not know the exact steps that will be required.
I suggested that without clear guidance FDA will rely on the guidelines it knows best, it's own.

There is an important difference between the two laws. Under the Food, Drug, and Cosmetics Act, the FDA is authorized to remove an unapproved product totally from the market, demanding that it go through the lengthy and expensive New Drug Application approval process, which requires animal studies plus several phases of clinical trials. Even after all that is completed, the FDA has been known to refuse approval. Example: The weight loss drug Rimonabant Rimonabant - Wikipedia, the free encyclopedia

Under the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act") the FDA is NOT authorized to remove any existing types of tobacco products from the market arbitrarily. Regulations can be issued for any type of tobacco product, but "approval" will only be required for new types of products and for those products that want to be known as "modified risk." True, the FDA can make life miserable for those making. selling, and using the existing tobacco products via oppressive regulations; but even that is better than having the products suddenly disappear completely.

 

[Our House]

There is an important difference between the two laws. Under the Food, Drug, and Cosmetics Act, the FDA is authorized to remove an unapproved product totally from the market, demanding that it go through the lengthy and expensive New Drug Application approval process, which requires animal studies plus several phases of clinical trials.

We can't even get HUMAN subjects to use an ecig correctly.

 

[Vocalek]

We can't even get HUMAN subjects to use an ecig correctly.

*giggle* Maybe we could get animals to teach the humans.

 

[trying]

I believe the Waxman Tobacco Control Act defines an "existing' tobacco product as having been on the market prior to 1997 or there abouts and making E-cigarettes a new tobacco product, which is where the trouble starts.

 

[rothenbj]

I believe the Waxman Tobacco Control Act defines an "existing' tobacco product as having been on the market prior to 1997 or there abouts and making E-cigarettes a new tobacco product, which is where the trouble starts.

From the FDA
"Tobacco products that were commercially marketed in the United States as of February 15, 2007 may continue to be marketed, but must comply with all provisions of the Tobacco Control Act. "

 

[Vocalek]

And one of our registered suppliers told me that he started marketing e-cigarettes in 2006.

 

[GregH]

And one of our registered suppliers told me that he started marketing e-cigarettes in 2006.

Thanks for clarifying that. All I could find related to when e-cigs were marketed in the U.S. stated "2006-2007".