IMPORTANT - email from FDA to a supplier.

[Chevron07]

Bill,

Being from PA, do you know if Arlen Specter is aware of the amendments to the Waxman legislation? I'm sure e-mails have been sent to his office, but we have no way of knowing to what extent this issue has been brought to his attention. As an advocate of standing up to cancer, tobacco alternatives should be something he could get on board with. Also, him and Lautenberg have a history of working together on bi-partisan legislation.

If Lautenberg has truly been misinformed, what would be the most powerful way to get his attention and make sure that he is fully informed? It doesn't feel like e-mails and phone calls have been enough.

 

[Mohave]

Mr. Godshall,

Of course it is immediately obvious that the bill in its current form will not serve the interests of public health, on many levels, but I'd really like to ask you about one particular aspect you just mentioned:

The Waxman FDA tobacco legislation (negotiated by Philip Morris and CTFK in 2003/04)would ban all new and recently introduced smokefree tobacco products (i.e. Camel Snus, Orbs, Strips and Sticks, Marlboro Snus and Moist Smokeless Tobacco), while allowing cigarettes to be sold at hundreds of thousands of retailer stores.

This is very interesting (and disturbing) to me. I understand the Camel snus, for example, were introduced in 2006. The summary of HR1108 I read at H.R. 1108 [110th] - Summary: Family Smoking Prevention and Tobacco Control Act (GovTrack.us) described a cutoff date of February 15, 2007 for grandfathering in existing products from the requirement for premarket approval (effective prohibition) of "new" products and innovations. I wonder if my understanding of this is in error?

I wonder even more about the effect on Swedish snus, which are of course much older products, made in Sweden for many years, but which many in the US do use. Many find them a very useful alternative to smoking or chewing tobacco.

If you are able to point me in the direction of any further information or clarifiction of this it would be much appreciated. Thank you so very much for informing us on this.

Requires premarket approval of all new tobacco products (products not substantially equivalent to an existing tobacco product) commercially marketed after February 15, 2007.

ADDENDUM: In the current HR1256 which recently passed the House I believe the relevant section is 910(a)(1)(A) & (B).

 

[Steph2323]

Bill,

Being from PA, do you know if Arlen Specter is aware of the amendments to the Waxman legislation? I'm sure e-mails have been sent to his office, but we have no way of knowing to what extent this issue has been brought to his attention. As an advocate of standing up to cancer, Tobacco alternatives should be something he could get on board with. Also, him and Lautenberg have a history of working together on bi-partisan legislation.

If Lautenberg has truly been misinformed, what would be the most powerful way to get his attention and make sure that he is fully informed? It doesn't feel like e-mails and phone calls have been enough.

I'm from Pa too and have written him 2 emails. I would like to know what he thinks also, given his cancer history. I also wonder about Kennedy, also with his cancer diagnosis. I am planning to handwrite some letters over the weekend, and will include Spector and Kennedy on the list.
Stephanie

 

[Roxi]

How is this thread gets more views than signatures on the petition???8-o

SIGN THE PETITION EVERYONE!!!...

(please?...)
​

 

[Mohave]

I also wonder about Kennedy...

Kennedy is the lead sponsor of this legislation (the bad Philip Morris version) in the Senate.

 

[talbrecht]

How is this thread gets more views than signatures on the petition???8-o

SIGN THE PETITION EVERYONE!!!...

(please?...)
​

Please sign the petition but this thread is probably getting viewed over and over again by the same people so the numbers are skewed.

 

[Txrider]

What about the intended use of 'water pipes'? Everyone knows what those are being used for. Everyone. Somehow those people managed to redefine their product and are now safely off the radar. You can buy a 'water pipe' at a convenience store!

Not only that, but you can also buy vaporizers right next to the water pipes in many places, for the same purposes... And I believe you can also vape tobacco in them just fine.

The e-cig should be legal easily, if disassociated with nicotine. It can vaporize many things.

It's the drug nicotine that the FDA grabs onto.

 

[gnubix]

It seems to me that the real issue here, the issue that gives the FDA jurisdiction (so to speak) is that selling a "drug-device" without approval is illegal. A "drug device" is a device defined as follows (taken for the Act quoted in the FDA letter):

(h) The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

therefore, if personal vaporizers are not "intended to affect the structure or any function of the body of man or other animals" then they cannot be regulated by the FDA according to the referenced Act.

Furthermore, Nicotine has many other uses - as a pesticide for instance.

Personal Vaporizers could have an excellent novelty use:
Perhaps one might buy a "personal vaporizer" as a nifty party gadget intended to blow "fog" out of one's mouth.

If someone were to put a flavored "pesticide" in it and inhale the vapor, well that would certainly be an unintended use for the device, no?

My point here is that I believe there is a way around FDA regulation here. Just like water pipes my friends.

 

[Mohave]

Ruyan (which retains an FDA drug law attorney)...

Good to hear that they have done that.

 

[Mary Kay]

Hello all. My Name is Mary Kay and I am new here. My husband and I just ordered e-cigs from Smoke Free and haven't even recieved them yet, now this! For Pete's sake, we have tried everything else, nothing has worked. It seems to me that if they were so dead set against smoking they would embrace anything that may help set you free! I have never understood the high cost of cessation products even if they worked.
I guess my timing is really off.
Mary Kay

 

[Oliver]

Mary, sign the petition, write to your elected representatives and keep hoping. This is a critical time and we need everyone to get involved.

 

[Steph2323]

Kennedy is the lead sponsor of this legislation (the bad Philip Morris version) in the Senate.

Thanks for letting me know. Oh well, at least there are others that we can pursue
Stephanie

 

[cure1245]

Hey, this is my first time posting guys. Name's Chris, and I've been vaping for about a month now. Found out a lot of info by lurking a bit, helped me find out that PVs are right for me. I've signed the petition and have started drafting a letter to just about every representative I could think of, from town to U.S. Senate. I really do hope that this doesn't slow us down too much... After two days use I couldn't stand the taste of burning tobacco anymore, and I really don't want to go back!8-o

 

[Steph2323]

Hey, this is my first time posting guys. Name's Chris, and I've been vaping for about a month now. Found out a lot of info by lurking a bit, helped me find out that PVs are right for me. I've signed the petition and have started drafting a letter to just about every representative I could think of, from town to U.S. Senate. I really do hope that this doesn't slow us down too much... After two days use I couldn't stand the taste of burning tobacco anymore, and I really don't want to go back!8-o

Welcome to the boards Chris. Thanks for jumping right in and helping the cause.
Stephanie

 

[cure1245]

Welcome to the boards Chris. Thanks for jumping right in and helping the cause.
Stephanie

Thanks for the welcome. I just wish I had joined in the discussions at a better time. But it's always darkest before the dawn, and I want to make sure we see that sun come up.

 

[Retina_Burn]

So..... what exactly do we have to fear. The vaporizers can vape legal herbs and homeopathic solutions. Done deal, I think I might set me up a webstore to sell just that. personal vaporizers for an easy way to get my legal and approved remedies into my body. Then I'll have a sister store that will have a nice big ad on this store. That store will sell the nic juice as an experimental substance "Not For Human Consumption" but for research purposes. I mean, I can get Magic Mushroom spores shipped from a retailer here in the good ol' US of A that sells them as a research item. As well as many "Experimental" substances. That new barbie drug that you inject subdermally to give you a tan and is an appetite suppressant. "Melanotan" I think. Also a research drug. As well as tons of steroids and HGH stuff. We should have no fear, we are smarter than the FDA and anti-nicotine advocates. That is what business is. The kind of tactic that the FDA is using is old news.....been done before with other substances. All are still sold in vast quantities.

Our suppliers just need to change the marketing tactics and may broaden their customer base as well. Old ladies wanting to vape some herbs that a friend told them would ease arthritis and stuff like that.

I for one am new to using a personal vaporizer and will not go back. The government cannot prosecute me for selling these things, and cannot seize any wares that are not deemed illegal. As far as I know........ I would not be breaking any law by selling something like this. Aren't there already PG based herb solutions for rubbing on skin and taking a spoonful of. I'd sell those right along with my other stuff. So FDA....... put that in your pipe and smoke it!

Been looking for a project and have a few friends that are going through the KU Law program that would love to help and put something like that on their resume. I say we have nothing to fear, we just have to be inventive.

ok..... I'm now off my soapbox.

 

[notstinkyanymore]

How is this thread gets more views than signatures on the petition???8-o

SIGN THE PETITION EVERYONE!!!...

(please?...)
​

I did. I'm new here and just recently discovered to my joy this alternative. I'm in a state of panic and just purchased via overnight another unit and supplies. Where I live taxation on smoking was abusively high anyway, now its nearly doubled overnight. I've written everyone I can think of including Lutenberg who BTW, lost a pile of money to the Madoff ponzi scheme. Perhaps big pharma is adding in the mix here as any alternative bites into their holy triple-digit profits otherwise.

The FDA can't even keep drugs used in hospitals clean and they want more power. Anyone recall Heparin and the DEATHS caused by tainted imports?

The FDA is sooo full of it. Does anyone realize that for soft drinks the substance benzoate used to ...... mold growth is processed into BENZENE in the body which is a huge carcinogen.

I'm really angry and sorry for the rant. The government says they want to support middle class Americans but its all rigged, all of it. Just what are they going to do when that black market arises in tobacco products because it will. Human nature and history tell us it will. After all Ted Kennedy and his family's fortune was made running liquor over the Canadian border during prohibition. IDIOTS.

 

[bizzyb0t]

You know, reading the e-mail from the FDA is damned depressing. It sounds like they're not going to buy that "it's just a personal vaporizer" line. They sounds like they do not care that the device doesn't always contain nicotine. They sound like they are insisting it's a "drug device" even if you're going to use it with PG and flavors.

I don't think any amount of wording and marketing adaptation is going to change the FDA's mind about their stance. It pretty much seems written in stone. All that's left for us is to speculate on why they're coming down so hard on these devices and seem hellbent on associating them with smoking cessation. Seems they're trying to pigeonhole our PV's into their regulatory jurisdiction and there's no way around it. If I had the money I'd buy beaucoup spare parts and liquid right about now...

Other people have mentioned "tobacco water pipes" (aka "bongs") being legal even though they're primarily used to smoke weed in. I think the difference is that those devices aren't a clear threat to the tobacco industry or Big Pharma.

There's big money to be made by cornering us into going back to analogs or using Big Pharma's high priced solutions. A lot of money is made treating smoking related diseases and if tomorrow, no one smoked a damned thing there'd be a lot of corporations out of a lot of money.

Perhaps it sounds a bit paranoid. However, I have very little trust in giant corporations and the government. Both have proved time and time again that they are easily corruptible. Capitalism doesn't exist but on the backs of the weak and poor.

I also feel that the personal vaporizer manufacturers in China will not feel a great loss of our business. They have no desire to try and tangle with the FDA here in the US, that's why their responses have been weak at best. The factories will just be refitted and they'll still be sending whatever else they end up manufacturing, here in the US. The ones that don't refit will still have their colossal market in China itself.

 

[Taelon]

Hello all, the supplier in question has asked to remain anonymous but has given me permission to reprint in full the email he received from the FDA.

Just automated FAQ-system answer, so debate tries with the "robot-sender" are useless, nobody will hear you.

And if the Mail from the FDA does not have a >= CLASS 3 certificate based electronic signature attached it is pure "smoke" and unlawful worthless, suppliers and online-sellers getting such invalid mails can ignore it by lawfully considering it as SPAM

 

[Jayhawks]

Hey are you in Ks?

So..... what exactly do we have to fear. The vaporizers can vape legal herbs and homeopathic solutions. Done deal, I think I might set me up a webstore to sell just that. personal vaporizers for an easy way to get my legal and approved remedies into my body. Then I'll have a sister store that will have a nice big ad on this store. That store will sell the nic juice as an experimental substance "Not For Human Consumption" but for research purposes. I mean, I can get Magic Mushroom spores shipped from a retailer here in the good ol' US of A that sells them as a research item. As well as many "Experimental" substances. That new barbie drug that you inject subdermally to give you a tan and is an appetite suppressant. "Melanotan" I think. Also a research drug. As well as tons of steroids and HGH stuff. We should have no fear, we are smarter than the FDA and anti-nicotine advocates. That is what business is. The kind of tactic that the FDA is using is old news.....been done before with other substances. All are still sold in vast quantities.

Our suppliers just need to change the marketing tactics and may broaden their customer base as well. Old ladies wanting to vape some herbs that a friend told them would ease arthritis and stuff like that.

I for one am new to using a personal vaporizer and will not go back. The government cannot prosecute me for selling these things, and cannot seize any wares that are not deemed illegal. As far as I know........ I would not be breaking any law by selling something like this. Aren't there already PG based herb solutions for rubbing on skin and taking a spoonful of. I'd sell those right along with my other stuff. So FDA....... put that in your pipe and smoke it!

Been looking for a project and have a few friends that are going through the KU Law program that would love to help and put something like that on their resume. I say we have nothing to fear, we just have to be inventive.

ok..... I'm now off my soapbox.