And now my discussion with the FDA

[pbusardo]

Again, this has been edited only to make easier to read. No content has been edited. As always, I enjoy reading your comments!

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


[FONT="]From:[/FONT][/B][FONT="] Busardo, Phil [mailto:xxx]
Sent: Tuesday, July 07, 2009 2:45 PM
To: CDER DRUG INFO
Subject: Electronic Cigarettes[/FONT][FONT="][/FONT]
[FONT="]Hello. I’m very interested in electronic cigarettes. I can’t figure out if they are legal or not and if they’ve been approved by your or not.[/FONT]
[FONT="] [/FONT]
[FONT="]Can you please provide me with some information including online resources you may have?[/FONT]
[FONT="] [/FONT]
[FONT="]Thank you![/FONT]
[FONT="] [/FONT]
[COLOR=black][FONT="]Phil J. Busardo[/FONT][/COLOR]
[FONT="] [/FONT][/COLOR]

[COLOR=black][FONT="] [/FONT]
[FONT="]From:[/FONT][/B][FONT="] CDER DRUG INFO [mailtoRUGINFO@fda.hhs.gov]
Sent: Thursday, July 09, 2009 3:15 PM
To: Busardo, Phil
Subject: RE: Electronic Cigarettes[/FONT]

[FONT="]Dear Mr. Busardo,[/FONT]
[FONT="] [/FONT]
[FONT="]Thank you for making your opinions known to the Agency. We appreciate your thoughts and experiences regarding electronic cigarette, cigar, and pipe products.[/FONT]
[FONT="]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. [/FONT]
[FONT="]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.[/FONT]
[FONT="]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.[/FONT]
[FONT="]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 [/FONT][URL="https://atlanta.securemail.hhs.gov/exchweb/bin/redir.asp?URL=http://www.smokefree.gov/"][FONT="]www.smokefree.gov[/FONT][/URL][FONT="]. [/FONT]
[FONT="]
Again, we appreciate the time that you have taken to contact us. [/FONT]
[FONT="]Best regards, [/FONT]
[FONT="]Division of Drug Information 7
Center for Drug Evaluation and Research
Food and Drug Administration [/FONT]
[FONT="] [/FONT]
[FONT="]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.[/FONT]
[FONT="] [/FONT]


[FONT="]From:[/FONT][/B][FONT="] Busardo, Phil [mailto:xxx]
Sent: Monday, July 27, 2009 10:07 AM
To: CDER DRUG INFO
Subject: RE: Electronic Cigarettes[/FONT][FONT="][/FONT]
[COLOR=blue][FONT="]I have read your recent report on the E-cig. Why does is seem like you are being hard on this new technology. I understand that they may not be 100% safe, but they HAVE to be safer than a real cigarette.[/FONT][/COLOR]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]Would it be possible for you to send me a side by side comparison of the chemicals contained in a real cigarette vs and electronic one. Then label the amounts and the danger factor. I’m trying to understand that I’m doing.[/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]I guess I could see the potential of someone who has not smoked before trying this and moving on to real cigarettes. I get that. But I really don’t believe it’s being marketed towards this crowd.[/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]We should be more focused on the people who DO smoke, who have tried this product and who NO LONGER smoke. Again, it MUST be a healthier alternative. AND, if it’s used the correct way with a lower and lower nicotine level then zero then no more e-cig, it must be a good thing.[/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]Can you PLEASE comment on this and provide me with the comparison.[/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]Thank you so much for your time. [/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=black][FONT="]Phil J. Busardo[/FONT]
[FONT="] [/FONT][/COLOR]

[COLOR=black][FONT="] [/FONT]
[FONT="]From:[/FONT][/B][FONT="] CDER DRUG INFO [mailtoRUGINFO@fda.hhs.gov]
Sent: Wednesday, August 12, 2009 8:45 AM
To: Busardo, Phil
Subject: RE: Electronic Cigarettes[/FONT]

[FONT="]Mr. Busardo,[/FONT][FONT="][/FONT]
[FONT="] [/FONT]
[FONT="]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. [/FONT][FONT="][/FONT]
[FONT="] [/FONT]
[FONT="]Best regards, [/FONT]
[FONT="]kw
Division of Drug Information
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 and 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. [/FONT]



[FONT="]From:[/FONT][/B][FONT="] Busardo, Phil [mailto:xxx]
Sent: Wednesday, August 12, 2009 8:55 AM
To: CDER DRUG INFO
Subject: RE: Electronic Cigarettes

[/FONT][FONT="]But at least 2 of the products have been submitted to the FDA for approval.[/FONT][/COLOR]
[COLOR=blue][FONT="] [/FONT]
[FONT="]E-Liquid from Johnson Creek in the US and e-liquid from Dekang in China. Both have been submitted to the FDA for approval. What about those products.[/FONT][/COLOR]
[COLOR=blue][FONT="] [/FONT]
[FONT="]In your testing of Njoy and Smoking anywhere, why were they not compared to 1) a real cigarette and 2) FDA approved nicotine delivery systems?[/FONT][/COLOR]
[COLOR=blue][FONT="] [/FONT]
[FONT="]Also, you’re not answering the question. You HAVE done some limited testing. You HAVE results on at least two manufacturers. So I will ask again, can you PLEASE send [/FONT][/COLOR][COLOR=blue][FONT="]me a side by side comparison of the chemicals contained in a real cigarette vs and electronic one. You can use the data found from your Njoy and Smoking Anywhere analysis. The chemicals in a real cigarette are well known.[/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]So, based on your testing, can’t you tell me that an e-cig is safer than a real one.[/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=blue][FONT="]I believe the comparison would look similar to the following:[/FONT]
[FONT="] [/FONT][/COLOR]
[B][FONT="]Product[/FONT][FONT="][/FONT]
[B][FONT="]NNN[/FONT][FONT="][/FONT]
[B][FONT="]NNK[/FONT][FONT="][/FONT]
[B][FONT="]NAT[/FONT][FONT="][/FONT]
[B][FONT="]NAB[/FONT][FONT="][/FONT]
[B][FONT="]Total[/FONT][/B][FONT="][/FONT]
[FONT="]Electronic cigarettes [/FONT][FONT="][/FONT]
[FONT="]3.87[/FONT][FONT="][/FONT]
[FONT="]1.46[/FONT][FONT="][/FONT]
[FONT="]2.16[/FONT][FONT="][/FONT]
[FONT="]0.693[/FONT][FONT="][/FONT]
[FONT="]8.183[/FONT][FONT="][/FONT]
[FONT="]Nicotine gum [/FONT][FONT="][/FONT]
[FONT="]2.00[/FONT][FONT="][/FONT]
[FONT="]Not detected[/FONT][FONT="][/FONT]
[FONT="]Not detected[/FONT][FONT="][/FONT]
[FONT="]Not detected[/FONT][FONT="][/FONT]
[FONT="]2.000[/FONT][FONT="][/FONT]
[FONT="]Nicotine patch [/FONT][FONT="][/FONT]
[FONT="]Not detected[/FONT][FONT="][/FONT]
[FONT="]8.00[/FONT][FONT="][/FONT]
[FONT="]Not detected[/FONT][FONT="][/FONT]
[FONT="]Not detected[/FONT][FONT="][/FONT]
[FONT="]8.000[/FONT][FONT="][/FONT]
[FONT="]Swedish snus[/FONT][FONT="][/FONT]
[FONT="]2400[/FONT][FONT="][/FONT]
[FONT="]Winston [/FONT][FONT="][/FONT]
[FONT="]2200[/FONT][FONT="][/FONT]
[FONT="]580[/FONT][FONT="][/FONT]
[FONT="]560[/FONT][FONT="][/FONT]
[FONT="]25[/FONT][FONT="][/FONT]
[FONT="]3365[/FONT][FONT="][/FONT]
[FONT="]Newport [/FONT][FONT="][/FONT]
[FONT="]1100[/FONT][FONT="][/FONT]
[FONT="]830[/FONT][FONT="][/FONT]
[FONT="]1900[/FONT][FONT="][/FONT]
[FONT="]55[/FONT][FONT="][/FONT]
[FONT="]3885[/FONT][FONT="][/FONT]
[FONT="]Marlboro [/FONT][FONT="][/FONT]
[FONT="]6600[/FONT][FONT="][/FONT]
[FONT="]Camel [/FONT][FONT="][/FONT]
[FONT="]3100[/FONT][FONT="][/FONT]
[FONT="]1400[/FONT][FONT="][/FONT]
[FONT="]2800[/FONT][FONT="][/FONT]
[FONT="]150[/FONT][FONT="][/FONT]
[FONT="]7450[/FONT][FONT="][/FONT]
[FONT="]Skoal [/FONT][FONT="][/FONT]
[FONT="]4500[/FONT][FONT="][/FONT]
[FONT="]470[/FONT][FONT="][/FONT]
[FONT="]4100[/FONT][FONT="][/FONT]
[FONT="]220[/FONT][FONT="][/FONT]
[FONT="]9290[/FONT][FONT="][/FONT]
[FONT="]Marlboro [/FONT][FONT="][/FONT]
[FONT="]4300[/FONT][FONT="][/FONT]
[FONT="]1800[/FONT][FONT="][/FONT]
[FONT="]4900[/FONT][FONT="][/FONT]
[FONT="]190[/FONT][FONT="][/FONT]
[FONT="]11,190[/FONT][FONT="][/FONT]
[COLOR=blue][FONT="] [/FONT]
[FONT="] [/FONT][/COLOR]
[COLOR=black][FONT="]Phil J. Busardo[/FONT]
[FONT="] [/FONT][/COLOR]

[COLOR=black][FONT="] [/FONT]

[FONT="]The only other information that we are able to provide to you is available at the following web link. There is [/FONT][FONT="][FONT="]Summary and Final Report of FDA Analyses[/FONT][/COLOR][/URL][/FONT][FONT="].[/FONT][FONT="][/FONT]
[FONT="] [/FONT]
[FONT="][url=http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm]Electronic Cigarettes[/url][/FONT][FONT="][/FONT]
[FONT="] [/FONT]
[FONT="]Best regards, [/FONT]
[FONT="]kw
Division of Drug Information
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 and 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. [/FONT]

 

[fonosmoak]

Hmm,

I think the bottom line here is that they will indeed be regulating the products in the near future.

They have a legitimate angle, "candy favored nicotine attracting children", yet a suspect end result, "that children will toss the candy flavor in favor of huffing actual tobacco.

This is a somewhat suspect yet powerful point of view.

In other words we haven't a chance of them just walking away from e-cigs.

Personally, I can see where someone might get themselves in trouble with the way it is right now: wide open, mega strength juice readily available.

I'm a veteran smoker, 45 years, last 15 wolfing down vast quantiles of hand roll tobacco like Drum.

First day with an PV I managed to give myself a headache.

Right now, I'm looking to dilute my 24mg. just so I can vape a bit more...

But the real BIGGY is that I've no need to smoke tobbacco anymore and that is a TRUE GOD SEND.

Glad I got mine before it went all Politically Correct.

Hey, they (FDA) will do what ever they want now.

Regards
fo

 

[ProtoType]

LOL They flat out lied to you in the e-mail until you called them out on the lab testing that they had indeed performed!

Ah the U.S. Government needs to realize that our founding fathers meant to establish a Government FOR THE PEOPLE BY THE PEOPLE and NOT CONTROL THE PEOPLE BY THE "ELITE".

Somehow in America, someone came along in Government and thought it'd be best to keep people out of the loop, lie to them, steal from them, over-tax them, and pretend to worry about their well-being. They treat us so well.

 

[hoodala]

If tobacco companies can slap a warning on their products and still sell them, why can't e cigs? Thank you FDA for your concern. I understand ecigs may be dangerous for my health (along w/ trans fats, sugar, artificial sweeteners, beef, mercury in tuna and pesticides on my veggies). Now mind your own business.

 

[pbusardo]

ProtoType,

Do you believe that? I lie followed by a song and dance. Unreal.

Hoodala,

The other day I go into a smoke shop. 100 varieties of bongs, 1000 varieties of pipes, 20 different rolling papers. 10 different body cleansers to prep you for a drug test. If you're going to slap the warning on anything, it should be on the juice, NOT the device.

 

[Dolmseth]

Fantastic post Phil - thanks for the info, I've wanted to read the FDA "straight from the horse's mouth" story.....

 

[Sun Vaporer]

Well Phil--the FDA is giving it to you straight. No applications or approvals and scant studies. Taken as a whole, I would not say the FDA blew you off here, rather they gave it to you straight. Looks like these manufactures are going to have to do what they should have done a long time ago -----make the application, do the stuides, and get the approval.


Sun

 

[pbusardo]

I'm not sure I understand Sun. Both Dekang and JC have applied for US FDA approval.

 

[Robert]

ProtoType,

Do you believe that? I lie followed by a song and dance. Unreal.

Hoodala,

The other day I go into a smoke shop. 100 varieties of bongs, 1000 varieties of pipes, 20 different rolling papers. 10 different body cleansers to prep you for a drug test. If you're going to slap the warning on anything, it should be on the juice, NOT the device.

Paypal will shut you down for selling a metal tube that will hold batteries- The T1. I don't even think he sells juice

 

[darkmatter22]

hummm there hiding something!

 

[808hustlin]

I bet if it was big pharm or a tobacco company that made the juice or created the device it would be approved already and for sale at walmart. The popularity of the ecig is growing rapidly with all the success stories and word of mouth, I don't think they could just ban them now, i think we have a lot of supporters along with happy spouses, childeren, friends & family that are so happy that many of us no longer smoke analogs.

 

[smiley7]

Great post Phil! Keep trying!

 

[davey]

these FDA emails look like some kind of automated response.. I bet someone at FDA sat in an office and typed up the rebuttals then shared them onto a network of other FDA email-representatives and those people read a blip of what you wrote them and send you another rebuttal... I mean how many emails could they be getting about e-cigarettes, it's almost like they're getting ready for a DoS attack.