James Watt, who is the owner of Instead Electronic Cigarettes and the Vice Chair of the Electronic Cigarette Association did a phone interview with Bill Cunningham on his radio show today. The interview was specifically about those who wish to include the electronic cigarette in smoking bans. You can use the audio player below to listen to the interview or read the transcript provided:

Transcript of October 26th, 2009 Interview of James Watt, ECA Vice Chair, on the Bill Cunningham Show on News Radio 700 WLW

BC is Bill Cunningham
JW is James Watt

BC Let’s continue with more. Twenty-nine minutes after this hour, Bill Cunningham, News Radio 700 WLW.

All right. Now there’s a big story on the front page of USA Today today that says that electronic cigarettes are battery-operated devices that turn nicotine and other chemicals into a vapor that is inhaled by the user, and they’re opening a new front in the tobacco wars because they give off no carcinogens, no secondhand smoke. And the battery-operated device is made up of a cartridge containing nicotine, flavoring, and chemicals. It turns nicotine, which is addictive, into a vapor that is inhaled.

Joining me now is James Watt, and he’s, like, vice chairman of the Electronic Cigarette Association. James Watt, welcome to the Bill Cunningham Show.

JW Thank you very much, Bill.

BC Well, let’s talk about this particular cigarette. About a half million Americans are now using these cigarettes. I’ve heard ads on our radio station that talks about these cigarettes. Talk about what they are and why they were developed.

JW Well, Bill, the–the electronic cigarette was–it’s been on the market for about five plus years now, and it’s been in the U.S. for, oh, about two and a half. Essentially, it’s an alternative to a tobacco cigarette. It works very similarly in the action where you bring something up to your mouth, you inhale, you exhale.

I think that the big difference between the two products is tobacco cigarettes use combustion, where the electronic cigarette uses vaporization. There are some very distinct differences between combustion and vaporization. So many longtime smokers find it to be a suitable replacement to their tobacco cigarettes.

BC So let’s say I’m sitting next to someone in a restaurant. I’m five–five feet away or six inches away. They’re right behind me, and they’re–and they’re using one of these electronic cigarettes. Would I even know it?

JW You would, provided you could see it. With most of the batteries on them, there is an LED will light up on the end when they inhale, and you will actually see the vapor come out. With that said, if you didn’t see the light, you didn’t see the vapor, you would not know they were using it. The–

BC Do they–do they smell?

JW No, they do not.

BC So a person that uses these–a lot smokers have smokers’ breath, and you can tell they’ve smoked because the clothes stink. That wouldn’t happen here?

JW That does not happen at all.

BC So is there any emissions at all that would rise the–raise the alarms of secondhand smokers?

JW Well, that’s a good question, an I’m certainly not a doctor or scientist that could get into specifically what’s in it. I can tell you many of the things that are produced specifically from combustion simply are not in that vapor. You know, the things that are typically produced with combustion, that’s where you get your arsenic, your carbon monoxide, your hydrogen cyanide. Those things are not produced through the process of vaporization.

BC So while the story seems to say that if you’re worried about secondhand smoke, that you’re not affected by it. Are you saying that’s true or untrue?

JW I’m saying that the electronic cigarette does not produce smoke–

BC No smoke at all.

JW –firsthand or secondhand.

BC So–

JW No smoke. It’s a vapor. There is a very distinct difference between the two.

BC And how expensive are these? If each cigarette has an indicator light, a battery, an atomizer, liquid cartridges, inhaler tips, how expensive is each cigarette?

JW Well, there’s a lot of different models on the market. I mean, there are disposable ones. But the vast majority are reusable, so the only thing you’re replacing is that cartridge with the liquid in it.

You know, typically, I think most smokers could see probably a forty to sixty percent savings by moving over to the electronic cigarette versus tobacco cigarettes.

BC Really? So you save money?

JW Absolutely.

BC Well, many states–California, New Jersey, most of the liberal ones, Oregon–are moving now to ban this. And the argument that was used for years is that you have to ban cigarette smoking in public because of secondhand smoke, because patrons would be affected, employees would be affected.

This cigarette undermines that entire argument, and I think those who oppose it are now showing their true colors because their argument is not that it produces secondhand smoke effects that are harmful. Their argument is that the person using it is harmful. So essentially, they don’t want to ban secondhand smoke. What they want to ban is cigarette use. Haven’t they showed their hand?

JW You know, I guess that’s to each their own in interpreting their actions. But I can say including the electronic cigarette with a smoking ban that does talk about, you know, specifically the secondhand smoke and the health effects of that, including the electronic cigarette in that seems unscientific, at best. You’re including something that just simply does not produce smoke.

BC And–and similar to MADD mothers, who started out trying to ban drunk driving, which is good thing, but now they’ve turned into a temperance organization. They’ve done all they can do with drunk drivers, punishing them disproportionately many times to other crimes committed by other criminals. They have now become an organization that wants to ban the use of alcohol, which is for years they said, “That’s not our intent.”

Much like the smoke–the smoke crowd, they began for years saying, “Secondhand smoke is terrible. It’s got to be stopped.” But now that the industry and now that the scientists have come up with a way to produce no secondhand smoke because there is no smoke–it’s a smokeless cigarette–now you have the left-wing activists that want to govern someone’s behavior and tell them they can’t smoke at all even though there’s no secondhand smoke.

So much like MADD mothers, to my way of thinking, they’ve demonstrated what their intent was all along, which was to ban tobacco use. And if they want to do that, James, go ahead and do it. Be forthright. But don’t use some other means or method to get to where you want to get, and then–and then what that detour was blocked by people like your trade organization, they now say, “Well, we don’t want people even to smoke smokeless cigarettes.” Why? Well, the answer is, “We don’t want you to do it.” And–and so it’s–it’s not–

JW It–

BC –it’s not about secondhand smoke. What it’s about is changing American behavior.

JW You know, some people definitely interpret it that way. I think it’s also important to understand that this product was not brought to the market by the tobacco industry. There’s no tobacco companies to my knowledge actually marketing the electronic cigarette, and there is no tobacco in it. You can have the cartridges with or without nicotine at all. There’s many users who will use the electronic cigarette with no nicotine. You know, so it’s–it’s not a tobacco product.

And I think that some of these organizations, it’s almost worse than–than the scenario that you mentioned simply because they don’t know about the electronic cigarette. There’s–I read through some of the proposals that they’re attempting to ban the electronic cigarette’s use in public places. It’s evident that they haven’t done the research to understand the product before they actually ban it.

BC Right. Well, James Watt, I’ve never smoked. I never would smoke. But I think American freedom means a lot, and if somebody wants to do this activity and no one else is affected by it, government has no role.

And, James Watt, do you want to give out a website for your group?

JW Yeah. Our website is ECASSOC.ORG.

BC All right. James Watt, good luck to you.

JW Thank you very much.

Governor Schwarzenegger Protects Adult Consumers’ Access to E-Cigarettes

Industry hails veto of anti-smoking alternative bill as victory for consumers, common sense

Washington, D.C. – October 12, 2009 | Matt Salmon, president of the Electronic Cigarette Association (ECA), today praised California Governor Schwarzenegger’s wise decision to veto Senate Bill 400, which would have banned electronic cigarette sales in the state, protecting adult consumers’ access to these alternative smoking devices.

“This is not just a victory for consumers and common sense but is smart public policy as well,” said Salmon. “Rejecting this bill is the right step and should serve as a model for other states to follow.”

In his veto message, Governor Schwarzenegger reiterated the stance of the ECA that strongly supports restricting access of electronic cigarettes to children under the age of 18. “We agree with the original intent of SB 400 to ban sales to those under the legal smoking age. And we support that on a national level as well,” added Salmon.

The Governor affirmed that this restriction should not apply to adult consumers: “If adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so unless and until federal law changes the legal status of these tobacco products.”

The ECA actively communicated to the Governor its members’ concerns about the bill and the fact that banning these electronic cigarettes would disenfranchise thousands of California adult smokers who have difficulty quitting but want an alternative to combustible cigarettes without the host of carcinogens and harmful chemicals. Salmon credited this legislative victory to the efforts of thousands of consumers and ECA members who appealed directly to Governor Schwarzenegger to protect their rights.

“While we know that combustible tobacco smoking kills over 400,000 Americans annually, and the percentage of smokers that quit every year is dismally low, we ought to be looking for more alternatives to traditional combustible tobacco products,” said Salmon.

Electronic cigarette kits usually include the electronic cigarette, a replaceable cartridge pack (that may or may not contain nicotine), rechargeable lithium batteries, and a charger. There is some variation between different companies in what is included in their starter kit, but all components are listed on their Web sites. While ECA members do not market these devices as a healthy alternative or smoking cessation device, it is clear that they do not contain the harmful tars and hundreds of carcinogens that consumers get from combustible tobacco products.

“We look forward to working with all government agencies, including the FDA, to ensure that consumers who want an alternative to combustible tobacco products have access to e-cigarettes that contain fewer harmful substances and produce no secondhand smoke,” concluded Salmon.

###

About the Electronic Cigarette Association

The ECA (www.ecassoc.org) is an association of private sector companies engaged in electronic cigarette technologies. Its mission is to provide the tools and information necessary for policy-makers, opinion leaders, media, and private sector companies worldwide to make informed decisions about the management and use of electronic cigarette technologies. The association institutes and promotes industry-wide standards and a code of conduct, works to maintain sound professional practices, educates the public and policy-makers on the industry’s activities and potential, and works to ensure the ethical use of electronic cigarette technologies.

According to the press release section of the official California Governor’s website, Senate Bill 400 (SB400) has been vetoed by Governor Arnold Schwarzenegger. To view California Bills signed and vetoed by the Governor, visit California Legislative Update 2.

The Governator included this veto message to the Senate:

To the Members of the California State Senate:

I am returning Senate Bill 400 without my signature.

While I support restricting access of electronic cigarettes to children under the age of 18, I
cannot sign a measure that also declares them a federally regulated drug when the matter is
currently being decided through pending litigation.

Items defined as “tobacco products” are legal for anyone over the age of 18. If adults want to
purchase and consume these products with an understanding of the associated health risks, they should be able to do so unless and until federal law changes the legal status of these tobacco products. For this reason, I am unable to sign this bill.

Sincerely,
Arnold Schwarzenegger

View the pdf version of Arnold’s message to the California State Senate here.

Thank you to the Electronic Cigarette Association, specific ECA members who took action against the Bill, doctors and health care advocates who contacted the Governor, and the many, many consumers in California (and beyond) who wrote letters and sent emails to ensure that they continue to have the right to choose an alternative to a known killer.

It is good to know that at least some elected officials still find it important to base legislation on fact and not media propaganda.

Thank you Governor Schwarzenegger for upholding the great American traditional; freedom of choice.

Matt Salmon, President of the Electronic Cigarette Association (ECA), today denounced a quotation attributed to him by Epiphany Media Group in a press release dated September 14, 2009. The falsely attributed quotation conveys the mistaken impression that some e-cigarette products have been approved by the FDA for consumer use. Salmon underscored the ECA’s commitment to abide by FDA regulations.

“It has come to my attention that a press release with false and misleading claims about e-cigarettes attributed to me was distributed without my knowledge or approval. I want to make it unequivocally clear that I have never made such statements or claims and they are patently false,” said Salmon.

The erroneous quotation, re-released on October 8, 2009, reads, “It is disheartening that the FDA issued a warning to the public against electronic cigarettes without conclusive data to support the claim.” The release goes onto say that Salmon indicated that “some of the companies that are part of the ECA such as inLife electronic cigarette product lines are approved by the FDA.”

“I don’t know of any electronic cigarette suppliers or manufacturers that have been approved by the FDA,” added Salmon. “All of our members send a warning card with every unit sold stating clearly that the product has not been approved by the FDA.”

The ECA’s policy is that member companies cannot make any health claims about their products or represent them as smoking cessation devices. E-cigarettes sold by these companies are marketed as simply an alternative to combustible tobacco smoking. Additionally, all members must ensure that they have taken precautions to prevent people under the legal smoking age from having access to their products.

“This requirement has been a long-standing policy of the ECA since its inception and we will take the necessary steps to enforce it,” Salmon concluded.

Visit www.ecassoc.org for more information about the ECA and its member companies.

On September 11, 2009 the California Senate passed Bill 400 which will “authorize action to halt the sale, distribution, or offering for sale of electronic cigarettes that have not been approved or cleared by the federal Food and Drug Administration.” California Senate Bill 400 was actually originally a Bill to create “The Alternative and Renewable Fuel and Vehicle
Technology Program”, then was amended to ban the sale of electronic cigarettes to minors, which we supported. Click here to view a full history of Bill 400. Of course now we do not support the Bill, as banning the product completely will mean limiting smokers choice to burning tobacco, which has well known effects on the body.

We encourage everyone who uses an electronic cigarette or knows someone who does or simply believes that the technology has public benefits to CONTACT THE GOVERNOR and ask him to veto Bill 400. If Governor Arnold Schwarzenegger does does not Veto the Bill 12 days after transmittal, it becomes law. He received the Bill on Sept 28th, so on Oct 10th the Ban on Electronic Cigarettes in California will become law and go into effect on January 1st, 2010.

If you are user or supporter of Electronic Cigarettes, Email Governor Arnold Schwarzenegger and ask him to Veto Bill 400. If you would like, you can use this text to email him:

Subject: Please Veto Senate Bill 400.

Senate Bill 400 is designed to ban electronic cigarettes which are an alternative to tobacco cigarettes that do not use combustion, but vaporization. Placing a ban on them now will force many users to go back to tobacco cigarettes at the expense of their health, their loved ones health, and the health of those around them.

Tobacco companies do not sell electronic cigarettes, small American companies do. And although more testing of electronic cigarettes is needed, a ban of this alternative while allowing the sale of tobacco cigarettes (which kills 400,000 American every year) is poor public policy and against public health.

Please Veto SB 400 and give smokers the right to choose an alternative to a known killer.

Signed,
–Your Name Here–

If you live live in California, in addition to sending an email, please call your Governor at 916-445-2841 or Fax a letter at 916-558-3160 or send a certified letter to:
Governor Arnold Schwarzenegger
State Capitol Building
Sacramento, CA 95814

Governor Schwarzenegger’s contact information

Governor Schwarzenegger is your elected official and if this issue is important to you, please act now to get your voice heard.

“Never doubt that a small group of thoughtful, committed, citizens can change the world. Indeed, it is the only thing that ever has.”
— Margaret Mead

UPDATE: California Bill Banning Electronic Cigarettes SB400 Vetoed by Governor Schwarzenegger

You must be thinking, Really? Who would think that let alone say it out loud. Well here’s the answer:

“There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term,” DeLancey said. “What we want to see are well-designed clinical studies. Personal reports are not enough,” DeLancy said. [Siobhan DeLancey who is a FDA Spokesperson]

This quote is from the Users love ‘e-cigarettes,’ but FDA wants to take closer look article published on September 30th, 2009.

First, let’s discuss the title of the article. Users, for the most part, do love their e-cigarette. However the FDA doesn’t want to “take a closer look”, what they are fighting for in their current legal battle is to classify the e-cigarette as a new drug / medical device thus named a combination product. This means it would be pulled off the market and made illegal until someone spends the money on the FDA application and does clinical trials to prove that it helps people quit smoking. And after the millions have been spent and the years pass, they would bring it back to be sold in pharmacies either OTC or by prescription. It is hard to compete with tobacco when you can’t sell in gas stations, tobacco shops, or online.

Now let’s look at what DeLancey from the FDA said, “There are no long-term studies on the health effects of just nicotine, minus the tobacco component.” – For the most part this is true.

Next, “We know what smoking tobacco does to the body over the long term,” – Yes, we do. It kills a rather large percent of the users

Then, “What we want to see are well-designed clinical studies. Personal reports are not enough,” – I am unclear about how you do a clinical study to provide data about usage over the long term. A 25 year clinical study?

The article then quotes some e-smokers who are very happy with their e-cigarettes. DeLancey ends with, “I feel their pain,” she said. “We don’t know if this is any better for them.”

Two immediate thoughts come to mind:

1) Based on this argument, if e-cigarettes are put through clinical trials and they are shown to kill a large percent of the users, will the FDA approve them for sale just as cigarettes are allowed? If not, why do combustible cigarettes get a free pass. Monopoly?

2) If DeLancey is a 25 year smoker who has tried to quit 14 times without success, then maybe she does feel their pain. However if that was the case, she would probably want to make the decision of what is better for herself. Smokers can do research on the competing products [e-cigarettes vs tobacco cigarettes]. There is data available, even if incomplete, to make a decision for themselves. It is not the FDA’s job to make decisions for adult Americans. It is their job to make sure that consumers have the proper information to make that decision. We applaud efforts by the FDA to ensure companies are not improperly marketing their products. We also hope they will see the potential of this product as we do and begin working with the industry, not try to re-locate it to pharmaceutical land.

1) FDA smoke screen on e-cigarettes in Washington Times by Dr. Elizabeth Whelan, president of the American Council on Science and Health

2) American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the Incoming Director of the FDA by Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force and Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians

3) Disingenuousness of the FDA’s Press Conference is Concerning; FDA and Anti-Smoking Groups are Committing Medical Malpractice on a Massive Scale by Dr. Michael Siegel, Professor at the Boston University School of Public Health

4) FDA’s drug and e-cigarette warnings counterproductive by Jeff Stier, associate director, American Council on Science and Health

5) Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes” by Janci Chunn Lindsay, Ph.D. from Exponent Health Sciences

6) An Interview With David Sweanor on the E-Cigarette, Tobacco harm reduction, snus and other issues from E Cigarette Direct out of the UK

7) The FDA Crusade Against E-Cigarettes by Brad Rodu, Professor of Medicine at the University of Louisville, holds an endowed chair in tobacco harm reduction research, and a member of the James Graham Brown Cancer Center at U of L

8) Prominent Public Health Physicians and Tobacco Researchers Expose Double Standard in the FDA’s Recent Study of Electronic Cigarettes and Challenge the FDA’s Alarmist Attitude Toward the Devices by Dr. Michael Siegel, Professor at the Boston University School of Public Health and Joel L. Nitzkin, MD, MPH, DPA, Chair AAPHP Tobacco Control Task Force and Brad Rodu, Professor of Medicine at the University of Louisville

9) Electronic Cigarette Association Letter To Congress by Matt Salmom, former Congressmen and President of the ECA

10) American Lung Association Asserts that E-Cigarettes are Designed to Promote Cigarette Smoking; Can Anti-Smoking Groups’ Reasoning Get Any More Absurd? by Dr. Michael Siegel, Professor at the Boston University School of Public Health

The articles above do not necessarily represent Instead’s position or opinion and no opinions within these articles should be taken as claims to the health, safety, or use of the electronic cigarette. As we have stated many times in the past, the most healthy thing to do is to quit smoking, period. The electronic cigarette is an alternative for long time smokers who have not been able to quit. It is not healthy or safe, but simply an alternative to smoking tobacco cigarettes.

On Thursday, September 10, 2009, an ad-hoc group of electronic cigarette users, calling themselves the Alliance of Electronic Smokers, filed an amicus brief in the litigation against the FDA by two electronic cigarette suppliers.

Here is the information regarding their brief:

MOTION OF ALLIANCE OF ELECTRONIC SMOKERS FOR LEAVE TO PARTICIPATE AND FILE BRIEF AS AMICUS CURIAE

The Alliance of Electronic Smokers (AES), as an interested nonparty, respectfully moves the Court for leave to participate and file a brief as amicus curiae in this litigation in support of Plaintiff’s and Intervenor-Plaintiffs’ Motions for Preliminary Injunction.

ARGUMENT

As set forth in greater detail in the accompanying Brief of Amicus Curiae, AES is an ad hoc group consisting of current consumers of electronic cigarettes (e-cigarettes) that would like to preserve their current choice of tobacco products – a right that is being eliminated by the efforts of the U.S. Food and Drug Administration (FDA) improperly to exert regulatory authority over e-cigarettes. AES and its members are concerned that their right to choose a preferred vehicle for smoking pleasure could be infringed based on the outcome of the present case. Accordingly, AES and its members have significant interests in the outcome of this litigation. Moreover, AES believes that its perspective would be helpful to the Court in evaluating the merits of this matter. In particular, AES responds to points raised in the submissions by Action on Smoking and Health (ASH), which this court has granted permission to appear as amicus curiae. AES is including as Exhibit A hereto its proposed amicus brief with this motion.

Because the proposed brief responds to points raised in ASH’s previous submissions in this matter, AES believes its participation will not prejudice any party. Pursuant to Local Rule 7(m), undersigned counsel has conferred by telephone with counsel for the Plaintiff and Intervenor Plaintiff, and they do not oppose this Motion. Also, AES conferred with counsel for Defendants regarding their consent and, as of the time of this filing, was still waiting for a response.

BRIEF OF AMICUS CURAE

ALLIANCE OF ELECTRONIC SMOKERS

The Alliance of Electronic Smokers is an ad hoc group of adult smokers who use and enjoy electronic cigarettes (”e-cigarettes”) for recreational purposes and wish to continue to do so. E-cigarettes have been available to smokers since 2007 and, until recently, the U.S. Food and Drug Administration (”FDA”) had made no effort to restrict their use. We wish to bring several points to the Court’s attention, and to comment on various issues raised by amicus Action on Smoking and Health (”ASH”) in its recent filings:

I. THE NEW TOBACCO ACT

If FDA wishes to regulate e-cigarettes, it now has an avenue to do so—through the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”), Public Law No: 111-31, H.R. 1256, 111th. Cong. (2009). FDA acknowledges that e-cigarettes would fit the statutory definition of a “tobacco product” under the FSPTCA. See Defendants’ Supplemental Brief In Opposition to Plaintiff’s and Intervenor’s Motions For A Preliminary Injunction, filed July 10, 2009, at 5 n.3. The FSPTCA reflects a legislative compromise. The Act allows FDA to regulate many elements of the production, labeling and advertising of “tobacco products,” while ensuring that nicotine cannot be banned for recreational use. FSPTCA Section 907(d)(3) (the Secretary may not “requir[e] the reduction of nicotine yields of a tobacco product to zero.”). Under section 901(b), FDA could regulate (but not ban) e-cigarettes following notice and comment rulemaking. Indeed, there is no statutory or other legal reason why FDA could not issue a notice promptly and complete this type of rulemaking in a matter of months.1

Congress recognized expressly in the FSPTCA that FDA did not previously have drug jurisdiction over tobacco products. FSPTCA, Sec. 2(7) & (12), Sec. 3 (1-7). The term “tobacco products” in the FSPTCA reflects the holding from the Supreme Court’s decision in FDA v. Brown & Williamson. 529 U.S. 120, 131, 158-59 (2000). In that case, the Supreme Court held that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products.” 529 U.S. at 126. Just as it has in this case, the FDA argued in Brown &Williamson that tobacco products were within its drug jurisdiction because they are intended “to deliver the pharmacological effects of satisfying addiction, stimulation and tranquilization. . . .” 529 U.S. at 131. But the fact that tobacco products deliver nicotine with stimulative pharmacological effects did not convince the Supreme Court that FDA had jurisdiction to regulate tobacco as a drug as customarily marketed for tobacco pleasure. Id. at 158-59. Indeed, the Supreme Court only noted one possible exception to its conclusion that FDA lacked drug jurisdiction over tobacco products – “with respect to the well-established exception of when the manufacturer makes express claims of therapeutic benefit.” Id. at 158-59 (emphasis supplied). As the Plaintiff and Plaintiff-Intervenor have argued in this litigation, there are no such claims of “therapeutic benefit” in the record in this case; nothing in the record shows such products were offered to help smokers them quit smoking (i.e. for smoking cessation) or for any other medical purpose.

II. FDA’s PRIOR VIEWS ON BROWN & WILLIAMSON

Until recently, FDA agreed that the Brown & Williamson case precluded it from exercising drug jurisdiction over “tobacco products” offered for sale for non-therapeutic purposes, i.e. as customarily marketed for “tobacco pleasure.” Indeed, in 2003 FDA considered a citizen petition requesting that FDA classify as a drug a new non-cigarette “tobacco product” named “Ariva” – a tablet consisting of “cigalett” pieces of compressed powdered tobacco, mint flavoring and other ingredients.” Like e-cigarettes, Ariva’s labeling indicated that it would deliver nicotine to its users “When you can’t smoke,” and indicated that the product “contains nicotine, an addictive substance.” See Attachment A hereto, August 29, 2003, letter from John M. Taylor, III, Associate Commissioner for Regulatory Affairs, FDA, at 2 (emphasis added). The FDA concluded that it did not have drug jurisdiction over Ariva and explained very clearly that it viewed the Brown & Williamson decision to cover this new “tobacco product:”

The Court [in Brown & Williamson] concluded that FDA has no jurisdiction over “tobacco products as customarily marketed” because they simply do not fit within FDCA’s regulatory scheme. The Court recognized that “customarily marketed” tobacco products do not include products for which claims of therapeutic benefit, including “drug claims” or “health claims” are made.” . . . . FDA believes that, based on the information available to it at this time, it is precluded from asserting jurisdiction over Ariva as currently marketed because it is a “customarily marketed” tobacco product within the meaning of Brown & Williamson.

Id. at 2-3 (citations omitted and emphasis added).

III. RESPONSE TO ASH’S AMICUS ARGUMENTS

ASH has filed an amicus brief, and apparently has also sent the court a letter with a ten-page single spaced commentary on the August 17th hearing, dated August 24, 2009 (the “August 24 letter”). Notably, much of the amicus material is not relevant here or part of the administrative record compiled by FDA. For example, neither of the e-cigarette manufacturers acting as plaintiffs here have advertised or sell their products as delivery mechanisms for approved drugs with therapeutic effects, like Cialis or Viagra, as ASH’s August 24 letter misleadingly suggests. Similarly, ASH purports to identify certain other relevant products containing nicotine, but none are relevant here, because: (1) those products made specific claims about therapeutic purposes, (2) they predated the Supreme Court’s holding in Brown & Williamson; and/or (3) they were not ever the subject of a judicial challenge. Moreover, ASH failed to mention the one post-Brown & Williamson precedent that actually is relevant here – Ariva, as discussed above, another unconventional nicotine product for which FDA received citizen petitions requesting that it assert jurisdiction – a request that the FDA flatly rejected in 2003, finding that it lacked jurisdiction over “customarily marketed” tobacco products.

In addition, ASH cites Harris v. Action for Smoking & Health, 655 F.2d 236 (1980), a case it lost in the D.C. Circuit, to support its position that explicit manufacturer representations regarding drug claims are not necessary. To the contrary, however, in that case, the D.C. Court of Appeals actually affirmed the lower court’s holding that FDA’s refusal to assert jurisdiction over cigarettes as a “drug” was not arbitrary, capricious, or contrary to law.

Far from supporting ASH’s argument, Harris made clear that:

. . . the crux of FDA jurisdiction over drugs lay in manufacturers’ representations as revelatory of their intent . . . . Such an understanding has now been accepted as a matter of statutory interpretation.

655 F.2d 236, 238-39. And to the extent that manufacturer’s objectively manifested intent can be inferred, the D.C. Court of Appeals explained:

. . . consumers must use the product predominately and in fact nearly exclusively with the appropriate intent before the requisite statutory intent can be inferred.

655 F.2d at 240.2 That is certainly not the case here. There is no evidence to suggest that consumers have used e-cigarettes predominantly, much less nearly exclusively, for purposes of therapeutic benefit. Our choice to use e-cigarettes over traditional cigarettes is instead influenced by social stigmas and inconveniences associated with traditional smoking. But practical concerns are also important: the e-cigarette leaves no tar stains on the roof of our cars or in our homes, and does not leave our skin, breath, or clothes smelling like an ashtray. Also, we are able to “smoke” in places that traditional smoking is prohibited because second-hand smoke is not an issue. And the electronic cigarette gives the user the same smoking pleasure as traditional cigarettes, including by mimicking the physical activity of smoking.

E-cigarettes are very different from products offered to help smokers quit. The nicotine patch and gum for example are meant to gradually assist users to eliminate their nicotine addiction. Those products describe in detail how to eliminate nicotine addiction in multiple steps. E-cigarettes are not marketed for that purpose, and the product labeling does not include directions or any other statements concerning how to quit smoking.

There are other nontraditional nicotine products, such as “Snus” and dissolvable tobacco products such as Ariva, that have no purpose other than to deliver nicotine for recreation. By attempting to eliminate our access to the electronic cigarette, the FDA is depriving us of our right as consumers to make an informed choice to use vaporized nicotine products.

IV. CONCLUSION

The Alliance of Electronic Smokers respectfully requests that the Court consider the consumer as an intelligent force and provide consumers the right to choose to use and enjoy electronic cigarettes, or personal vaporizers, as a choice. Accordingly, for the reasons set forth in this case by Plaintiff Smoking Everywhere, Inc. and Plaintiff-Intervenor Sottera Inc. d/b/a NJOY, and for the additional reasons set forth herein, we urge the Court to hold that FDA lacks the authority to interfere with that choice, and to grant the requested preliminary injunctions.

1. In contrast, it takes, on average, approximately eight years to obtain FDA approval of a drug, from the initiation of clinical trials through the FDA approval process. See Tufts Center for the Study of Drug Development, Outlook 2009, available at http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2009.pdf (last visited September 8, 2009). During this time, the unapproved drug cannot be marketed or sold.

2. ASH also cites U.S. v Travia, 180 F. Supp. 2d 115 (D.D.C.2001) for the proposition that a written label is not required to infer a seller’s intent. But Travia is readily distinguishable – there, undercover agents presented evidence of oral representations made to customers about the purpose of the product sold, and the case had no bearing at all on tobacco products.
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For the pdf version click: Electronic Smokers Amicus Brief

Congrats to the Consumers who stood up for their rights to choose an alternative to a known killer! Every voice counts and every voice should be heard!

August 29, 2009
Lawrence Deyton, MD
Incoming Director
FDA Center for Tobacco Products
Re: Don’t Write Off Current Smokers

Dear Dr. Deyton:
For the past half century, the American Association of Public Health Physicians (AAPHP) has served as the national voice of physician directors of state and local health departments and other like-minded physicians. We have long been involved with tobacco control, with the singular goal of doing everything in our power to reduce tobacco related illness and death.

As you assume leadership of the new FDA Center for Tobacco Products, we urge you to consider the actions FDA can take, within the powers granted by this new legislation, to rapidly and substantially reduce tobacco related illness and death in current adult smokers.

Unfortunately, FDA has not gotten off to a good start. FDA condemnation of electronic cigarettes, in its July 22 press conference, and FDA insistence that electronic cigarettes should be regulated as a drug/device combination rather than as a tobacco product makes no sense from a public health perspective. It flies in the face of FDA laboratory findings on other products already approved by FDA. If one looks at electronic cigarettes as a sentinel for all tobacco products less hazardous than conventional cigarettes – the outlook for FDA action reducing tobacco-related illness and death among current adult smokers is dismal.

With this in mind, we respectfully request your consideration of the following actions:

1. We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes.

2. We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.

This year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness. Their second hand smoke will kill about 48,000 non-smokers. About 700 more will die in residential fires. Despite progress on other measures of tobacco use, per CDC estimates, this death count continues to inch up from year to year. In contrast, even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.

Our (AAPHP) best estimate is that smokeless tobacco products currently cause about 700 cancer deaths per year in the United States. This is less than 1% of the more than 110,000 deaths that would occur each year if smokeless products carried the same mortality as conventional cigarettes.

This last week, Boffetta and Straif published a paper alleging evidence of an increased risk of fatal heart disease and stroke among smokeless tobacco users. This is a study sure to be referenced by those seeking evidence of the harmfulness of smokeless tobacco products. Unfortunately, this study suffers from major technical and ethical flaws, including failure to note in the abstract that they found no increased risk of non-fatal heart attack or stroke. Even worse, of the many studies reviewed, only two showed evidence of even a slight increase in risk of death – and these were the ones selected for the conclusion and abstract. That having been said, their allegations of a 13% increase in risk of fatal heart attack and 40% increase in risk of fatal stroke pale in comparison with the 180% to 300% increases in risk for men and women 35-64 years of age posed by smoking conventional cigarettes.

Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products. Smokeless tobacco products carry little or no risk of heart disease and no risk of lung disease. They do not kill innocent bystanders and they do not burn down houses. The risk of cancer of any kind from smokeless products ranges from a high of about 5% of the risk of cancer posed by conventional cigarettes to a low well under 1% of the risk of cancer posed by conventional cigarettes. While definitive studies have not been done, we have reason to believe that tobacco products, such as electronic cigarettes, consisting of nicotine extracted from tobacco with only trace amounts of other chemical substances, should carry even less risk.

Most of the discussion to date around the new FDA/Tobacco bill has focused on reducing initiation of nicotine use by children and teens. The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.

It should be possible to save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years. This could be done by making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit. Rather than discouraging nicotine cessation, however, such an approach, even with no medical intervention, would be expected to triple the rate at which current smokers eventually discontinue their nicotine use.

Those writing the new FDA legislation endorsed a harm reduction component to current tobacco control programming, but in a most peculiar way. The law encourages cigarette manufacturers to develop “reduced exposure“ products and market them with no scientific proof that such reductions in exposure will reduce risk. The law then requires presumably new “scientific evidence” for smokeless products, already known to be of substantially lower risk. This makes no sense. The law encourages a harm reduction component to current tobacco control programming that might reduce tobacco-related cancer mortality by one or two percent; while actively discouraging switching to lower risk tobacco products that promise to lower total tobacco-related illness and death by 99% or better.

The secret to success, as we see it, will be to add an effective harm reduction component to current tobacco control programming while using the tools made available by this new law to prevent this new harm reduction
initiative from increasing the numbers of children and teens who initiate tobacco use.

Reconsidering the FDA stance on electronic cigarettes would be the most logical first step.

We look forward to working with FDA to use the powers granted by this new legislation to rapidly and substantially reduce tobacco-related illness and death, among both current and potential future tobacco users.

References:
The data on smoking attributable deaths on page 2 of this letter are from the Centers for Disease Control MMWR report of November 14, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm

The estimate that 20% of current nicotine consumption in the United States is from smokeless tobacco was generated by Mr. William Godshall, based on the formula utilized by Fagerstrom et al, when estimating 2002 nicotine consumption by type of tobacco product in multiple countries.

The discussion on risk of heart disease and stroke from smokeless tobacco products is from Paolo Boffetta and Kurt Straif : Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. Published August 18, 2009. BMJ 2009; 339: b3060 [Abstract] [Full text]

The data on relative risk of fatal heart attack and stroke from smoking, in men and women 35-64 years of age, are data from the American Cancer Society as quoted in “Changes in cigarette-related disease risks and their implication for prevention and control.” Smoking and Tobacco Control Monograph 8. Bethesda, MD: US Department of Health and Human Services,
Public Health Service, National Institutes of Health, National Cancer Institute 1997;305-382. NIH Publication no. 97-1213.

The other references to the scientific literature that back-up the points made in this letter can be found on the Tobacco Issues page at the http://www.aaphp.org web site. There is an October 2008 “Resolution and White Paper on Tobacco Harm Reduction.” This paper, on pages 6 and 13, includes then-current CDC and AAPHP mortality projections. “The Myth of the Safe Cigarette,” is based on the paper by Pankow et al (http://cebp.aacrjournals.org/cgi/reprint/16/3/584 ) and others. It makes the case that conventional cigarettes cannot be made measurably safer. The exchange of correspondence with Zhu et al, from a paper published earlier this year, deals with the difference in quit rates, comparing conventional cigarettes to smokeless tobacco products.

Yours,
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln@jln-md.com
504 899 7893
Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians
ksherin@yahoo.com

Conflict of Interest Disclaimer: Neither of us, nor the American Association of Public Health Physicians, has received or anticipates receipt of any financial support from any tobacco product manufacturer or vendor, or any pharmaceutical firm making nicotine replacement products.

Visit American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the Incoming Director of the FDA to download the PDF version of the letter.

The Electronic Cigarette Association has just released a letter on it’s website that it will be sending to each member of Congress as well as some other public officials. In it, along with some information about the very poor job the FDA did in testing the electronic cigarette, there is important information about the position of the ECA when it comes to selling to kids. He is a quote:

“We do agree with the FDA, however; that E-Cigarettes should not be purchased or consumed by those under the legal age of smoking. We support any legislation, be it state or federal, that makes it illegal to sell e-cigarettes to children and those under the legal smoking age. We only market our products to committed long term smokers and would never want this to entice anyone who is not already addicted to nicotine to use our product.”

We at Instead Electronic Cigarette fully support the ECA’s stance and agree that it is important to keep those under the legal smoking age from purchasing electronic cigarettes or any other product that may contain nicotine.

Read the full Electronic Cigarette Association Letter To Congress