Received this email from FDA

[Higbe33]

Maybe a form letter, but thought I would pass it on.

Dear Mr. Wood:

Thank you for your email regarding electronic cigarettes. Your email was forwarded to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research (CDER) for a response.
At this time, we are not aware of any data establishing electronic cigarettes as safe and effective for their intended uses. Based upon our case by case review of a number of these products, they are drug/device combinations that require approval by FDA before they may be legally marketed in the United States.

None of these so-called electronic cigarettes or their components has been approved by FDA. Therefore, the marketing of the products FDA has reviewed is not legal in the United States. As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.

There may be a perception among some users that electronic cigarettes are a safe and effective means to quit smoking conventional forms of tobacco. However, FDA is not aware of any scientific data to support those perceptions. Since these products have not been submitted to the FDA for evaluation or approval, the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. FDA also found varying levels of nicotine in cartridges labeled as containing the same level of nicotine as well as the presence of nicotine in cartridges labeled as containing no nicotine. These test results indicate that these products are manufactured under inadequate or non-existent controls.

FDA is concerned that electronic cigarettes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences.


Again, we appreciate the time that you have taken to contact us.


Sincerely,
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
kcd

 

[Smislow]

Governements live off our taxes, tobacco factories are a huge tax payers...
If they can impose same range of taxation on e-cig products as on tobacco, they will pay for advertizing e-cigs!
It needs a few more court precendants to establish a government policy on e-cigs.
But it won't happen untill FDA outrages a really BIG importer by seizing his goods.
Why not an FDA order a torough chemical/medical/clinical study on e-cigs to determine if they are harmful for human consumtion?
Because tobacco is being banned allmost from everywhere, and BIG cancer sticks producers are concerned about their revenues, goverment alike.

 

[RIMP]

Exactly
RIMP

 

[CherylannM]

Thanks for posting the letter you received! For the heck of it, I did a fast Yahoo search for "products containing diethylene glycol" and found 2 interesting sites right off the bat. I'm posting the links below:

Diethylene Glycol Information | Diethylene Glycol Guide | GoodGuide

The above site really floored me ... it shows common products by brand name, and things I use all the time like Febreze and Sally Hansen nail products are on the list. An eye-opener to be sure.

Diethylene glycol: Facts, Discussion Forum, and Encyclopedia Article

This one is more "scientific" type info, but gives an interesting history towards the bottom of the page.

Thought some of the ecf members may find these sites of interest, particularly the first one.

 

[yvilla]

Higbe33, it is a form letter, and one that has been in use since more than two years ago! I would have hoped that they would have changed it by now, given the huge legal developments since its first appearance in early 2009 or thereabouts.

Is this just a case of the left hand not knowing what the right hand is doing, or is it stubborn, willful intransigence in the face of an authoritative ruling of a federal Court of Appeals?

I urge you to consider sending a reply - one that attaches the FDA's recent official court filing in the Njoy case and the affidavit of FDA Division Director Domenic Veneziano. For in this filing they appear to concede to the legal ruling that e-cigs without therapeutic clams are NOT "drug/device" products, and cannot be regulated as such by the FDA. Here are a couple quotes from the FDA's own statements in this filing:

The Court enjoined FDA from detaining or refusing admission to SE’s and Sottera’s e-cigarettes unless the products were intended to have a therapeutic effect, and stated as follows:

[A]bsent substantial evidence of the manufacturer’s objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from “customarily marketed” tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette.​

And:

Because Smoke Anywhere is challenging a now-defunct policy, it cannot establish standing, subject matter jurisdiction, or an interest that would be impaired by this litigation. After the D.C. Circuit held that nicotine-containing products can be regulated as “drugs” and “devices” under the FDCA only if they contain therapeutic claims, Sottera, Inc., 627 F.3d at 898, FDA changed its policy to comply with that ruling. See Veneziano Decl. ¶ 5. Similarly, FDA is no longer following the portion of IA 66-41 related to three e-cigarette manufacturers because that portion of the import alert is superseded by FDA’s new e-cigarette policy. Id. ¶ 6.​

Here is a link to the above-quoted FDA filing: http://www.casaa.org/files/FDA's memorandum in opposition to SA's motion to intervene.pdf

And to Veneziano's affidavit: http://www.casaa.org/files/Declaration of Domenic Veneziano (FDA) in NJOY v. FDA re importation.pdf

So please, reply to whoever sent you that ancient form email, and tell them to get real!

 

[John Phoenix]

I agree Yvilla.

If the Division of Drug Information in the FDA's Center for Drug Evaluation and Research (CDER) is going to misrepresent the truth so badly it tells me they are doing it on purpose. They have got to know the recent rulings and decisions that directly effect their jobs. There is no excuse for them to send out an obsolete form letter unless they were trying to hide the truth and pull the wool over peoples eyes.

This to me is an outrage.

 

[Moonflame]

It would be interesting to know what Judge Leo would think of them sending this letter that might as well say they are ignoring his ruling. I wonder if it could be considered contempt of court.

 

[Rubicon]

"Follow the money."

I remember reading it cost Phillip Morris 3 cents to make a pack of smokes. They then sell it at 5 cents, all the rest of the 5-8 bucks a pack is state and federal taxes. Tobacco is a huge money maker, and currently, they don't make squat off PV's. They will push for regulation/taxation until they get it, this will never go away.

 

[Vocalek]

You could forward a copy of the email to Margaret Hamberg, with a copy to the Director of the Center for Drug Evaluation and Research

TO: margaret.hamburg@fda.hhs.gov

CC: janet.woodcock@fda.hhs.gov

SUBJ: Incorrect Information Disseminated by CDER


Dear Commissioner Hamberg: I am attaching a copy of the email that I recieved on _______ from the U.S. Food and Drug Administratrion's Center for Drug Evaluation and Research (CDER.) Would you please notify the Director of CDER that the FDA, to comply with the ruling of the U.S. District Court for the District of Columbia, has changed its policy and will no longer detain shipments of electronic cigarettes unless they contain therapeutic claims. Also, inform the Director that the quantity of nitrosamines FDA detected in its "limited testing" is equivalent to the quantity in an FDA-approved nicotine patch, and that the quantity of diethylene glycol detected is thousands of times below the toxic level. It would be best if all FDA employees are asked to refrain from dissemination of partial truths that mislead the public to believe that e-cigarettes are so dangerous that people would be better off smoking.

------------------------------------

Then, if you do not receive a response within a reasonable amount of time--let's say 15 days--you print all of it out and mail it to Judge Richard J. Leon with a note letting him know that you suspect that the FDA is in Contempt of Court.

 

[John Phoenix]

Higbe33

Ya haven't posted back in this thread. I hope your seeing it. I too would like to see ya send such a letter and the response or lack there of. In case ya missed it.. I think I'll PM ya and give ya a heads up to check this thread. ( I know it's easy to get lost on this forum)

 

[Higbe33]

Sorry....... been busy. Vocalek - Thank you so very much for doing the leg work for me and I sent the letter off just now. I will post what I receive back.

Hig

 

[Vocalek]

Wow! This may be Overcome By Events, but nevertheless we shall see. The FDA just announced today that it will regulate electronic cigarettes as tobacco products. Be that as it may, it is entirely possible that the wonks who work for CDER a) are not keeping up with the whole issue and b) have still not been notified of what's going on by their management. They could continue mindlessly sending out that same form response forever unless someone stops them.

Here is the announcement: Regulation of E-Cigarettes and Other Tobacco Products

 

[John Phoenix]

The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Regulation of E-Cigarettes and Other Tobacco Products

User fees. Does this mean they will be able to tax the hell out of E-cigs and ruin it for us? I'd rather the FDA just stay the hell out of my life and body, they have done enough damage already.

I know there are some folks on here who say we must have FDA regulation. Trouble is that would be good and fine if the FDA had someone to regulate THEM and everything not be so manipulated by Big Pharma and other greedy corporations and politicians trying to make their states rich off of our asses. It's a two edged sword and we will be cleaved in twain sooner or later.

As a layperson I have studied health and nutrition for years and I know the FDA pulls lots of crap. They do one thing that looks good on the surface but it carries hidden harm once you dig deeper into the issue. This is standard business practice for the FDA. The FDA kills tons of people each year with it's corrupt policies. I would rather see the FDA be disbanded and some honest agency start up in it's place.

With the DIY stuff I'm buying I can afford to use e-cigs. If they tax the hell out of the liquid nicotine I will have to go back to smoking my 5 dollar a week TOP tobacco. I don't want That.

If I read this correctly:

Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent.

I would think that the liquid nicotine would be safe and grandfathered in because that has not changed and has been being sold for years. Am I right?

End rant. Sorry folks.

 

[Higbe33]

I don't know how to post a link, but check out yvilla's post here.

http://www.e-cigarette-forum.com/forum/legislation-news/182522-fda-regulate-e-cig-tobacco.html

A wealth of knowledge and darn she writes good!!

 

[John Phoenix]

I don't know how to post a link, but check out yvilla's post here.

http://www.e-cigarette-forum.com/forum/legislation-news/182522-fda-regulate-e-cig-tobacco.html

A wealth of knowledge and darn she writes good!!

Thanks for the link, and yeah I agree with you - these ladies are super sharp!

 

[John Phoenix]

Ya know that article also states:

The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Tobacco has over 4000 ingredients - why don't they have to be listed on cigarette cartons? That's just not right. I say whats good for the goose is good for the gander.

 

[Higbe33]

Update - I never got a reply to my e-mail. Even though things have changed, a return e-mail should have been sent.

Hig

 

[Vocalek]

Ya know that article also states:

Tobacco has over 4000 ingredients - why don't they have to be listed on cigarette cartons? That's just not right. I say whats good for the goose is good for the gander.

That's a point of confusion. "Ingredients" would cover the chemicals present when the product is sold. Tobacco companies have a list of just under 600 chemicals they are permitted to add, most of which have to do with flavoring, so not all of these is ever present in any one product. Where the "4,000" number came from is that whenever you burn something, the process of combustion causes chemicals to break up and recombine into new chemicals. Someone estimated (nobody has actually counted) that when you light up a cigarette, about 4,000 new chemicals are created. Some of these are toxic, and some are carcinogenic, but most are fairly innocuous.

 

[rothenbj]

That's a point of confusion. "Ingredients" would cover the chemicals present when the product is sold. Tobacco companies have a list of just under 600 chemicals they are permitted to add, most of which have to do with flavoring, so not all of these is ever present in any one product. Where the "4,000" number came from is that whenever you burn something, the process of combustion causes chemicals to break up and recombine into new chemicals. Someone estimated (nobody has actually counted) that when you light up a cigarette, about 4,000 new chemicals are created. Some of these are toxic, and some are carcinogenic, but most are fairly innocuous.

Gee, and we thought that Flavored cigarettes were banned, except menthol, of course. I think it would be great to insist all flavoring, except menthol (of course) be banned. I wonder how many corps and ?non-profits" would be up in arms. That would certainly take away Big Red's competitive advantage.

 

[MattZuke]

Gee, and we thought that Flavored cigarettes were banned, except menthol, of course. I think it would be great to insist all flavoring, except menthol (of course) be banned. I wonder how many corps and ?non-profits" would be up in arms. That would certainly take away Big Red's competitive advantage.

I'm pretty sure "flavored" cigarettes are banned. This doesn't include "little cigars". They can't make for example a chocolate cigarette, however they can use chocolate in a cigarette. It has utility since raw tobacco is almost unpalatable, and you have to add things to mellow it out.

Cigarette Ingredients | Tobacco Ingredients