From Alabama Senator Richard Shelby

[crazyhorse]

Here's a copy of correspondence that I received by snail mail from one of our senators.
------------------------------
May 13, 2009

Dear Mr. ....****:

Thank you for taking t.he time to contact me regarding the FDA's approval of personal vaporizers also known as electronic cigarettes.

I have contacted the FDA on your behalf and have asked them to respond to your concerns. You should expect a reply to your concerns directly from the agency in a timely manner. Please do not hesitate to contact me about this or other matters in the future.

Sincerely,
~~
Richard Shelby

Here's the copy of what he sent to the FDA:

------------------------------
May 13, 2009

Stephen R. Mason
Assistant Commissioner For Legislative Affairs
Food and Drug Administration
15B-31 Parklawn Building
5600 Fishers Lane
Rockville, Maryland 20857-0001

Dear Friend:
Enclosed, please find a copy of correspondence I received from Don ....****.

Please review the enclosed and address the concerns raised. I have notified my constituent to expect a timely reply directly from you.

Sincerely,
~~
Richard Shelby

And here is a copy of what I sent the senator:

------------------------------
May 03, 2009

Dear Senator Shelby,

My wife and I have recently discovered a product we determine to be beneficial to our health and future. This is a smoking alternative called the e-cigarette or the Personal Vaporizer. Personal vaporizers use a mixture of propylene glycol and nicotine to deliver a smoking-like sensation without tobacco, intense heat or any risk of fire. As such, the product contains none of the 60 known carcinogens in tobacco (or the 3000+ other chemicals). And, of course, despite the exhalation of an odorless smoke-like vapor, the personal vaporizer leaves no second-hand smoke in the air and presents no known danger to anyone.

I decided to contact you and ask for your help because it seems apparent the FDA and Congress may be in the process of banning this smoking alternative, no doubt at the insistence of the tobacco and pharmaceutical lobbies.

Currently, some very powerful senators are pushing the FDA to stop the importation of personal vaporizers. The claim is that the safety of the product is unknown. While I understand this fear, I find it unlikely that a product with no carcinogens could be as great a health risk as continuing to smoke tobacco cigarettes.

I humbly request your support in preventing the FDA from banning this product. I know that a great many smokers have either significantly reduced or quit their cigarette habit with this product. Many of these individuals have been 1-2 pack a day smokers for most or all of their adult lives and have quit smoking entirely with the personal vaporizer.

As a former cigarette smoker, I can say that traditional nicotine replacement therapies fail to provide the gratification the act of smoking brings. The personal vaporizer delivers that satisfaction with, I believe, a significantly reduced health risk. I have a strong personal interest in this issue because my wife of 27 years is a heavy cigarette smoker and has been for close to 30 years now. Although she is a tremendously strong person and a successful businesswoman, she has tried time and time again to quit but has never succeeded. With this product available to her, we have a realistic hope that she can quit smoking cigarettes and trust me, over the years we have tried everything from hypnotherapy to timing devices to every type of nicotine replacement that has come on the market.

With the advantage of the Personal Vaporizer, she can finally be free of that which will cause her to die before her time while still being able to continue doing something that is obviously important to her. The beauty is she can continue with this activity that gives her happiness but in much a safer manner. She is completely off cigarettes at this time and I hope she has the opportunity to remain that way.

Thank you for your support,
Don ....****

 

[Kate51]

POWERFUL.
And a great response. I got an auto-reply, so far that's it. Will post whatever I get, whenever I get it.

 

[yvilla]

Wonderful letter you wrote, Don. Thank you! And a relatively encouraging response you got too.

 

[crazyhorse]

Steven Mason, Assistant Commissioner for Legislation, responded to the request presented by Senator Shelby. Not by responding directly to me, as the Senator requested, but by responding to the Senator himself. Senator Shelby sent the letter on to me.

This Steven Mason is obviously not a very bright boy. In his response to the Senator, he not only changed my name from Don to Dan, he also relocated me to some place called Robertsville.

He claims FDA has taken no steps to ban e-cigs but will act upon a congressional mandate that requires refusal of admission into the country if they are marketed as a smoking cessation device and remain unapproved.

I also received a very positive letter from Senator Shelby in the interim. I suppose I should find it, scan it and post it here as well.
____________________________

The Honorable Richard C. Shelby
United States Senate
Washington, D.C. 20510-0103

Dear Senator Shelby:

Thank you for your letter of May 13, 2009, to the Food and Drug Administration (FDA or the Agency) on behalf of your constituent, Dan ....**** of Robertsville, Alabama, asking you to oppose a ban on "electronic cigarettes." FDA has not taken steps to ban the importation of such products. Following is some background regarding this product and FDA's recent regulatory actions.

Although there are several different brands with different designs and formulations, the electronic cigarettes that FDA has examined generally contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional tobacco products. They are typically designed with a rechargeable, battery operated heating element that volatilizes chemical constituents (usually including nicotine) contained within replaceable cartridges. Nicotine has well-recognized pharmacological effects, and the scientific and medical communities have determined that nicotine addiction is a disease. Thus, electronic cigarettes deliver volatilized chemical substances to affect the body's structures and functions, and/or to mitigate or treat the symptoms of nicotine addiction, through a chemical or metabolic action on the body.

Congress has directed the Agency, under the Federal Food, Drug, and Cosmetic Act (the Act), to refuse the admission of a drug or a device into U.S. commerce if it appears to be adulterated, misbranded, or unapproved, based on an examination of the samples or otherwise. Part of that assessment involves determining whether a particular product is a drug or a device under the Act, which depends on its "intended use." In order to make that determination, FDA has been examining shipments of electronic cigarettes on a case-by-case basis and has considered the product information described above, as well as the product's label and labeling, advertising or promotional materials, and other relevant sources.

With respect to several shipments of electronic cigarettes, FDA has determined that those products were making drug claims, and therefore, fell within the definition of "drug" and "device" under the Act. The Act generally prohibits the marketing of drugs and devices unless and until the product sponsor submits and obtains FDA approval of an application that establishes the product's safety and effectiveness for its intended use. For example, other manufacturers and distributors have submitted applications to FDA and obtained approval to market nicotine replacement therapies in the form of gums, transdermal patches, a nasal spray, an inhaler, and lozenges. None of the electronic cigarettes or their components that we have reviewed have been covered by an approved new drug application, an approved application for premarket approval, or an approved application for an investigational device exemption. Thus, FDA believes it has properly refused admission of these products.

FDA is sympathetic to people who wish to quit smoking. FDA encourages these people to meet with their health care professionals to discuss use of approved smoking cessation products.

Thank you for contacting us concerning this matter. If we can be of further assistance, please let us know.

Sincerely,
~~
Stephen R. Mason
Assistant Commissioner for Legislation

 

[STILLSMOK9]

Steven Mason, Assistant Commissioner for Legislation, responded to the request presented by Senator Shelby. Not by responding directly to me, as the Senator requested, but by responding to the Senator himself. Senator Shelby sent the letter on to me.

This Steven Mason is obviously not a very bright boy. In his response to the Senator, he not only changed my name from Don to Dan, he also relocated me to some place called Robertsville.

He claims FDA has taken no steps to ban e-cigs but will act upon a congressional mandate that requires refusal of admission into the country if they are marketed as a smoking cessation device and remain unapproved.

I also received a very positive letter from Senator Shelby in the interim. I suppose I should find it, scan it and post it here as well.
____________________________

The Honorable Richard C. Shelby
United States Senate
Washington, D.C. 20510-0103

Dear Senator Shelby:

Thank you for your letter of May 13, 2009, to the Food and Drug Administration (FDA or the Agency) on behalf of your constituent, Dan ....**** of Robertsville, Alabama, asking you to oppose a ban on "electronic cigarettes." FDA has not taken steps to ban the importation of such products. Following is some background regarding this product and FDA's recent regulatory actions.

Although there are several different brands with different designs and formulations, the electronic cigarettes that FDA has examined generally contain no tobacco leaf or stem material, but are designed to look like conventional cigarettes. They are intended to be manipulated and used (inhaled) in ways similar to how a smoker manipulates and uses conventional tobacco products. They are typically designed with a rechargeable, battery operated heating element that volatilizes chemical constituents (usually including nicotine) contained within replaceable cartridges. Nicotine has well-recognized pharmacological effects, and the scientific and medical communities have determined that nicotine addiction is a disease. Thus, electronic cigarettes deliver volatilized chemical substances to affect the body's structures and functions, and/or to mitigate or treat the symptoms of nicotine addiction, through a chemical or metabolic action on the body.

Congress has directed the Agency, under the Federal Food, Drug, and Cosmetic Act (the Act), to refuse the admission of a drug or a device into U.S. commerce if it appears to be adulterated, misbranded, or unapproved, based on an examination of the samples or otherwise. Part of that assessment involves determining whether a particular product is a drug or a device under the Act, which depends on its "intended use." In order to make that determination, FDA has been examining shipments of electronic cigarettes on a case-by-case basis and has considered the product information described above, as well as the product's label and labeling, advertising or promotional materials, and other relevant sources.

With respect to several shipments of electronic cigarettes, FDA has determined that those products were making drug claims, and therefore, fell within the definition of "drug" and "device" under the Act. The Act generally prohibits the marketing of drugs and devices unless and until the product sponsor submits and obtains FDA approval of an application that establishes the product's safety and effectiveness for its intended use. For example, other manufacturers and distributors have submitted applications to FDA and obtained approval to market nicotine replacement therapies in the form of gums, transdermal patches, a nasal spray, an inhaler, and lozenges. None of the electronic cigarettes or their components that we have reviewed have been covered by an approved new drug application, an approved application for premarket approval, or an approved application for an investigational device exemption. Thus, FDA believes it has properly refused admission of these products.

FDA is sympathetic to people who wish to quit smoking. FDA encourages these people to meet with their health care professionals to discuss use of approved smoking cessation products.

Thank you for contacting us concerning this matter. If we can be of further assistance, please let us know.

Sincerely,
~~
Stephen R. Mason
Assistant Commissioner for Legislation

Bla, bla, bla, bla, bla, bla, bla, bla

 

[enrogae]

That response is a bit disappointing. More bureaucratic pandering.

 

[Surf Monkey]

The letter supports exactly what I was saying in a couple of other threads... and was roundly slammed for suggesting: that the FDA is not enforcing a ban on PVs and has yet to formulate a specific regulatory framework around them.

FDA has not taken steps to ban the importation of such products.

FDA has been examining shipments of electronic cigarettes on a case-by-case basis and has considered the product information described above, as well as the product's label and labeling, advertising or promotional materials, and other relevant sources.

In other words, they're flying by the seat of their pants right now. The situation remains fluid and could change at any moment.

 

[MaxxVapor]

This is only my opinion. The FDA is checking and detaining a small percentage of e-cig supplies coming in to the US. If the SE and NJoy suit fails then you will see these percentages rise until they effectively wipe us out.

 

[vjnnc]

Before I even started to use the e-cig I knew the government would somehow find a way to screw it up. I'm no conspiracy theorist, but in spite of their assertions, they do NOT want people to stop smoking. Most importantly, they do not want to lose the tax revenue cigarettes generate.

Having the FDA involved in any manner is just such an oxymoron - they'll permit the continued sale of tobacco - that we all KNOW will kill you....e-cigarettes can stop that.

Nicotine is addictive; smokers are already addicted - no brainer. Nicotine will not kill you (in this manner) - cigarettes will.

Until the government can figure out a way to tax the crap out of these, they'll make waves.

Unreal

 

[vjnnc]

BTW - I'm glad to see SOMEONE on a federal level is representing. I will soon fire off a couple of messages to my representatives.

 

[SSRob]

I think all of us as suppliers need to hammer the factories to re-write the booklets that come with these things. The user manuals themselves explain it as a cessation device and could give reason to an inspector to refuse a shipment. Some of the stock boxes need changed also.

The front of my DSE901 manual says "Healthy", "Safe"

Table of contents: "How to abstain from smoking by using this product - Page 18"

You can market the thing any way you wish, but the manual itself says what it says.

We as mass buyers of these CAN get them to change their packaging. It may not be the solution but it sure could help.

 

[MaxxVapor]

Very good point SS. I recently asked that my kits not be shipped with the booklet but a better solution would be to have them change it. Maybe we could get something going in the suppliers forum?

 

[Mary Kay]

This the same letter I got when writing to the FDA. Word for word.

 

[drakefire]

Alright guys, I'll jump in on this.

As a military member, I've written my SC state senator several times on state law matters.... i have always received a very hasted response, usually within 24-48 hours. I'll throw my javalin at Sen. Graham and see how he responds. I will post my updates as they come.

 

[crazyhorse]

MaryKay,

This is interesting. Senator Shelby will be rather upset when he learns that FDA sent him a form letter. Can you please identify the exact point where this letter becomes a form letter?

 

[drakefire]

Alrighty, Operation Letter to Senator successful. How many other have written letters? I think we'd have a much better push at getting our Senators on our side if more people flooded them with requests for help.

I will post my original letter + reply once I receive one.

 

[Anchova]

MaryKay,

This is interesting. Senator Shelby will be rather upset when he learns that FDA sent him a form letter. Can you please identify the exact point where this letter becomes a form letter?

This is actually a superb point. If you (or anybody else) has a scan of this addressed to somebody else, it should be sent to the Senator. Request that he probe the FDA for something more than bureaucratic form letters, at a time when 400,000 people are dying from smoking every single year.

 

[Mary Kay]

I deleted the first letter by accident! This is the second letter! I meant to delete this one.

Dear Mrs. ****,
Thank you for making your opinions known to the Agency. We appreciate your thoughts and experiences regarding electronic cigarette, cigar, and pipe products.
At this time, we are not aware of any data establishing electronic cigarettes, cigars, or pipes as generally recognized among scientific experts as safe and effective. Based upon our investigation 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, cigars, and pipes, or their components, has been approved by FDA. Therefore, the marketing of them in the United States is subject to enforcement action. 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, cigars, or pipes are safer alternatives to conventional tobacco products. There may also be a perception that these products 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 the amounts of nicotine or the kinds and amounts of other chemicals that the various brands of these products deliver to the user. FDA is concerned that electronic cigarettes, cigars, or pipes 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.
There are a number of proven safe and effective cessation aids that smokers can use to quit smoking. The U.S. Public Health Service’s, Treating Tobacco Use and Dependence: 2008 Update recommends using a combination of proven cessation interventions including FDA approved nicotine replacement therapy and/or non-nicotine medications and counseling to more than double a smoker’s chances of quitting successfully. Free help is available to smokers in all states by calling 1-800-QUIT-NOW or by visiting www.smokefree.gov.

Again, we appreciate the time that you have taken to contact us.
Best regards,
Division of Drug Information 7
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21CFR10.85(k) and constitutes and informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

​

 

[seminolewind]

I got a form letter from the fda too. Same one. Gosh, I wish a REAL person would write a reply sometimes........

 

[crazyhorse]

The one received and posted here by MaryKay is the very common generic email letter posted elsewhere as "Response from the FDA"

I'd like evidence the letter sent to my senator is also a form letter. He received it in the form of a snail mail letter that came as direct correspondence from a honcho at Department of Health and Human Services.

Anyone?