Friday, July 30, 2010

New Study Shows that Thirdhand Smoke is 100 Times More Dilute than Secondhand Smoke

What may be the first investigation to actually measure the ambient levels of thirdhand smoke and compare them with levels of secondhand smoke, a new study published in the current issue of Tobacco Control reports that concentrations of particulate matter in thirdhand smoke were 100 times lower than in secondhand smoke, measured in the same room (see: Becquemin M. Third-hand smoking: indoor measurements of concentration and sizes of cigarette smoke particles after resuspension. Tobacco Control 2010; 19:347-348).

Here's what the study did:

"A smoking device burned 10 cigarettes in 30 minutes in a non-ventilated furnished room that was then kept closed. On the next day, for particle resuspension, we mobilised the dust on furniture, clothes and surfaces by wiping and shaking and created even more turbulence with a ventilator. An impactor (ELPI) measured the particle sizes (between 0.28 μm and 10 μm) and concentration in the air, 60 cm above the floor: on the first day before and after the cigarettes were smoked (secondhand smoke) then 4 hours later, 24 hours later, before and after resuspension manoeuvres (thirdhand smoke)."

Here's what the study found:

"after cigarette smoking: the airborne particles ... concentration was divided by 100 in the first 4 hours and again by 100 in the following 24 hours. After resuspension, the concentration was multiplied by 100, going back to that observed 4 hours after smoking."

The study concludes: "These quantitative data support the hypothesis of a resuspension from the cigarette smoke surface contamination. However, this airborne contamination through resuspension remains much lower (100 times) than that of secondhand smoke."

The Rest of the Story

This study confirms that thirdhand smoke is a real phenomenon. Particles that deposit on surfaces during smoking can later become re-suspended in the air. Importantly, however, even under these conditions of extreme agitation of the deposited particles (wiping, shaking, and ventilator turbulence), the particulate concentration in the thirdhand smoke was two orders of magnitude lower than in the secondhand smoke.

This study confirms what I have been asserting repeatedly since the thirdhand smoke "scare" was initiated: yes, it's true that thirdhand smoke exists, but the levels of exposure are so low that there is no substantial health risk to anyone - other than to infants or those who are extremely sensitive to tobacco smoke - and even for those groups, the risks are small compared to the secondhand smoke. Thus, thirdhand smoke becomes a theoretical, but not a practical, health concern.

These data also appear to refute the claim by Action on Smoking and Health that smokers themselves pose a hazard to nonsmoking workers by bringing in particles deposited on their clothes that will later enter the air and exposes nonsmokers. The data clearly argue against policies that deny employment to smokers based on the potential health hazards of thirdhand smoke exposure among their fellow workers.

These data also appear to refute the assertion that thirdhand smoke is a substantial health concern in general. If people live in a home with smokers who smoke in the home, the secondhand smoke exposure will be so much higher than the thirdhand smoke exposure that it renders the effect of the thirdhand smoke essentially meaningless. And if the only exposure is thirdhand smoke due to the smoker smoking outside the home but bringing back particles on his or her hair and clothing, then there seems to be no concern at all about significant health effects.

This research should put the faddish focus on thirdhand smoke where it belongs: in the circular file. Unfortunately, the state of California is devoting millions of dollars to a research program that focuses on....

... you guess it.....

...thirdhand smoke.

Thursday, July 29, 2010

Study Concludes that Higher Intensity Puffing Required for E-Cigarettes May Have Adverse Effects on Health, But Doesn't Consider Toxicity of the Vapor

A new study published online ahead of print in the journal Nicotine and Tobacco Research finds that electronic cigarettes require higher intensity puffing than conventional cigarettes and concludes that this may result in adverse health effects.

According to the study: "Except for one brand, higher vacuums were required to smoke e-cigarettes than conventional brands. Smoke/aerosol density was stable for conventional brands and for e-cigarettes over the first 10 puffs; however, aerosol density of e-cigarettes dropped during subsequent smoking, and higher vacuums were required to produce aerosol as the puff number increased."

The study concludes: "Generally, e-cigarettes required stronger vacuums (suction) to smoke than conventional brands, and the effects of this on human health could be adverse. The amount of aerosol produced by e-cigarettes decreased during smoking, which necessitated increasing puff strength to produce aerosol. The decreased efficiency of aerosol production during e-cigarette smoking makes dosing nonuniform over time and calls into question their usefulness as nicotine delivery devices."

The Rest of the Story

This paper seems to be missing one major point: it is the toxicity of what you are smoking or vaping that makes it harmful, not simply how hard you are puffing.

Increased intensity of puffing on electronic cigarettes compared to conventional cigarettes would only make vaping more harmful if the constituents of electronic cigarette vapor were harmful to begin with. The abstract omits any mention of the fact that conventional cigarettes contain perhaps tens of thousands of chemicals and more than 40 carcinogens while electronic cigarettes contain none of the above, other than the nicotine. It also omits mention of the fact that there are no hazardous chemicals that have been identified in electronic cigarette vapor at anything other than trace levels that are known to have significant adverse health effects.

In other words, the paper is ignoring the factor which is the overwhelming determinant of the relative safety of electronic cigarettes: the chemicals present in the inhaled vapor.

Instead, the paper focuses exclusively on one small aspect of the product's use: the puffing intensity.

While this would be fine if the paper simply kept to a discussion of puffing intensity, it fails to do that, as the abstract's discussion section goes so far as to argue that the increased puffing intensity of electronic cigarettes may make these products more harmful to users. Why draw conclusions that are pure speculation and are not supported by any evidence within the paper itself? This editorializing makes it appear that the paper has a pre-determined conclusion about the safety of electronic cigarettes.

Similarly, the paper concludes that electronic cigarettes are not a useful nicotine delivery device based solely on one factor - the lack of consistency in nicotine delivery - but ignoring the much more important evidence: whether the product has been found to be or not to be effective as used by actual human beings. Once again, the paper is drawing a conclusion that goes beyond the scope of the actual findings. This editorializing also makes it appear that the paper has a pre-determined conclusion about the effectiveness of electronic cigarettes.

While the paper's findings regarding the level of puffing intensity for electronic cigarettes compared to conventional cigarettes are interesting, they clearly do not support the type of sweeping assertions that the paper makes in postulating the implications of the study.

Wednesday, July 28, 2010

Why Do Anti-Smoking Groups and Researchers Recommend Pharmaceutical Cessation Aids for Every Patient When Unaided Quitting is More Effective?

Not long ago, an NIH expert panel released a 2008 update of the clinical practice guideline regarding the treatment of tobacco use and dependence (see: Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008).

The guideline recommends that every patient who wishes to quit be treated with pharmaceuticals, unless medically contraindicated. The guideline also recommends the use of Chantix, despite concerns about its potential suicide risk, a risk that is currently being investigated by the FDA. Among the pharmaceuticals recommended by the panel are:
  • buproprion;
  • nicotine gum;
  • nicotine patch;
  • nicotine nasal spray;
  • nicotine lozenge;
  • nicotine inhaler;
  • Chantix; and
  • combinations of the above.
The expert panel was supposedly guided by scientific evidence in drawing its conclusions. It chose to recommend the use of pharmaceutical aids for every individual trying to quit smoking, presumably, due to research showing that drug-aided cessation is more effective than unaided cessation.

Many national anti-smoking groups have echoed the expert panel's recommendations. To be sure, pharmaceutical-aided smoking cessation is at the core of the national tobacco control movement's strategy and recommendations.

The Rest of the Story

But what does the scientific evidence show?

Those who have read the Clinical Practice Guideline on smoking cessation treatment may be shocked to find out that the scientific evidence clearly shows that unaided smoking cessation is substantially more effective than pharmaceutical-aided cessation.

For example, Larabie found that smokers who quit unaided were 2.3 times more likely to succeed than those who quit using pharmaceutical aids. Contrary to the dogma expressed in the smoking cessation expert panel report, unplanned quit attempts were found to be more successful than planned quit attempts. The paper concludes that in light of this finding: "the current guidelines may be hindering, rather than assisting successful smoking cessation." This research has important implications for the type of advice that health professionals deliver to patients regarding smoking cessation. The appropriate recommendations, however, are completely at odds with those presented in the expert panel report.

In a similar study by West and Sohal, unplanned quit attempts were found to be 2.5-2.6 times more likely to be successful than planned quit attempts.

To be sure, nicotine replacement therapy is known to be dismally effective in treating smoking dependence. Among smokers who are not particularly motivated to quit, the six-month success rate for nicotine replacement therapy is a dismal 6.8%.

Why would the NIH expert panel and major anti-smoking groups recommend drug-aided cessation when this strategy has been shown to be less effective than unaided cessation, and when even short-term success rates among unmotivated smokers are as low as 7%? This means that our national experts are recommending a treatment that fails 93% of the time! Even worse, they are recommending a treatment that fails 93% of the time when there is an alternative which has been clearly shown to be more than twice as effective.

The Answer

The answer to the question posed above, and in this post's title, is actually quite simple.

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore (panel chair): "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.

As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.

One national expert on smoking cessation who was not on the panel - John Polito - has suggested that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.

Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.

What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.

The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.

It may come as a surprise to many in tobacco control, but this type of science is just as bad. Bad science is bad science. Conflicts of interest are conflicts of interest. Believe me, the science doesn't get any stronger just because it is a less detestable industry. As a field which has literally helped to ruin the careers of scientists with tobacco industry connections, we should be beyond reproach in not allowing similar conflicts of interest to degrade and poison our science.

Tuesday, July 27, 2010

Will World Health Organization Declare that Winston Cigarettes are Safer and/or Less Enticing to Kids than Other Cigarettes?

According to an article in the Louisville Journal-Courier, Kentucky's main crop - burley tobacco - could be devastated by regulations being proposed by a working group of the Framework Convention on Tobacco Control (FCTC).

How could this be?

Well, the story is a bit convoluted, but here it is:

On May 15, the Working Group on Articles 9 and 10 of FCTC issued draft recommendations for implementation of the treaty's provisions related to the regulation of tobacco product ingredients. The basis of these recommendations is that tobacco companies should not be allowed to add any compounds to their products which increase the appeal, attractiveness, or palatability of the product.

The draft recommendations state: "Tobacco products are commonly made to be attractive in order to encourage their use. From the perspective of public health, there is no justification for permitting the use of ingredients, such as flavouring agents, which help make tobacco products attractive."

Based on the above, the working group recommends as follows: "Parties should either prohibit or restrict ingredients that may be used to increase palatability, such as sugars and sweeteners, flavouring substances, and spices and herbs, in cigarette-like tobacco products. Parties should prohibit or restrict ingredients that have colouring properties, such as inks and pigments, in cigarette-like tobacco products."

Now, the clincher here is that burley tobacco tends to be so bitter that it requires some flavorings to be added in order to make it palatable. So while the proposed ban on cigarette additives is not designed specifically to prohibit the use of burley tobacco, it results in a de facto ban on burley tobacco because without additives, the use of burley tobacco becomes unfeasible for taste reasons.

Since a major part of the economy, especially in states like Kentucky, is threatened, the key question is whether there is any scientific or public health justification for the proposed ban on cigarette additives.

The Rest of the Story

To answer the above question, we need to examine closely the public health community's response to Winston cigarettes, which according to both its producer and its competitors, does not contain any additives.

Remember that laboratory studies conducted on the re-formulated Winston cigarettes confirmed that these products were in fact 100% tobacco with no additives. Interestingly, these analytic studies were carried out by British American Tobacco, which concluded that the no-additive Winston cigarette "seems to be truly a product with no additives." There were no humectants, no added sugars, no flavorings, and no added ammonia.

The question to the World Health Organization, then, is this: Does WHO acknowledge that Winston cigarettes are a significant public health advancement over all other brands because the absence of additives makes these cigarettes less attractive to youths?

In response to Winston's "no additive" campaign, the public health groups went berserk. They complained to the Federal Trade Commission. They blasted R.J. Reynolds for wildly misleading consumers about the relative safety of these cigarettes. The FTC stated, quite clearly, that there is no evidence that "cigarettes without additives are safer to smoke than other cigarettes." Reynolds was eventually forced to put a disclaimer on all of its advertisements stating that "No additives does not mean a safer cigarette."

Moreover, none of the anti-smoking groups, including the WHO, applauded R.J. Reynolds for having produced a cigarette with less appeal to youths. Not a single one of these anti-smoking groups congratulated Reynolds for putting out a cigarette with no additives, which would lead to substantially less enticement of youth.

Here, then, is the fascinating conundrum for the WHO and the FCTC working groups. If they argue that there is a public health justification for banning all cigarette additives, then they must acknowledge that Winston cigarettes are a significant public health advancement and that R.J. Reynolds has produced a product that significantly contributes toward public health objectives.

On the other hand, if they refuse to acknowledge that Reynolds' Winston cigarettes are a public health advancement, then they are admitting that there is no public health justification for their proposed regulations that would ban all cigarette additives.

Which will it be?

Monday, July 26, 2010

New Study Provides Strong Evidence of Causal Association Between Chantix and Violent Acts Towards Others

A new research study published online ahead of print in the journal Annals of Pharmacotherapy concludes that the drug Chantix (varenicline) is most likely causally associated with thoughts and acts of aggression and violence (see: Moore TJ, Glenmullen J, Furberg CD. Thoughts and acts of aggression/violence toward others reported in association with varenicline. Annals of Pharmacotherapy 2010).

The authors identified 26 cases of FDA-reported adverse drug events associated with varenicline that included acts and thoughts of aggression and violence toward others and met the WHO criteria for possible, likely, or certain association with the drug. This excluded cases involving suicide if there was no violence toward others. In all 26 cases, there were inexplicable and unprovoked acts or thoughts of violence toward others. In 24 of these 26 cases, there was no indication of a prior history of violence. Perhaps most importantly, in 10 of 11 cases in which there was information about the effect of the discontinuation of varenicline, the symptoms resolved in a few days after the drug was discontinued.

The study concludes as follows: "These data contain several characteristics that add scientific weight to the accumulating evidence that varenicline is associated with unprovoked acts and thoughts of aggression/violence toward others. The temporal relationship evidence was strong, with an early and often immediate onset of abnormal dreams and thoughts, and the adverse effects usually resolved with discontinuation of treatment. In the 3 rechallenge cases, the adverse effects reappeared (often in more severe form) when the drug was restarted and disappeared when the drug was stopped again. The patient population of predominantly middle-aged women was typical of those who are trying to quit smoking with varenicline but is an unlikely age group and sex for assault and acts of violence toward others."

The Rest of the Story

It appears that after careful review of the adverse events associated with Chantix that were reported to the FDA, we now have about as strong the evidence that we could possibly have that Chantix is causally associated to sudden, inexplicable and unprovoked acts of aggression and violence toward others in the absence of any prior history of similar events.

Oddly, despite the fact that Chantix has been clearly associated with fatal adverse events, the major anti-smoking groups are not calling for its removal from the market. At the same time, the same groups are calling for another product that is being used for smoking cessation - electronic cigarettes - to be removed from the market even though there have apparently been zero adverse events reported to the FDA.

The logic here makes no sense to me. There are hundreds of reports of severe and even fatal adverse events from Chantix, a drug which fails to produce long-term smoking cessation nearly all the time that it is used (that is, about 88%) but anti-smoking groups want it to stay on the market. At the same time, these groups want to pull from the market electronic cigarettes, which anecdotally appear to be quite effective in achieving smoking cessation and which have no known or reported adverse effects.

Now don't misinterpret this post. I'm not necessarily calling on the removal of Chantix from the market. However, I do think that we should treat electronic cigarettes and Chantix in a manner that is consistent, logical, and sensible.

When a product on the market is benefiting many people and leading to marked health improvement, the burden of proof is on those who want it removed from the market to demonstrate that the product is causing harm. This is why we err on the side of leaving products on the market until they are shown to be harmful. Since electronic cigarettes are already on the market, I feel that the same standard should hold. They should be removed from the market only if it is demonstrated that they are causing adverse effects. The burden of proof is on those who want the product removed.

Thus far, no one has demonstrated that there are adverse effects from electronic cigarettes, nor has anyone so much as offered a plausible hypothesis for how electronic cigarettes could cause harm to users (i.e., pointed to a chemical or chemicals in the product that are known to be health hazards).

Removing electronic cigarettes from the market would, with certainty, cause harm to thousands of vapers. You don't knowingly cause harm to people simply because of the speculation that a product could have adverse effects. Yet that's precisely what the anti-smoking groups want the FDA to do.

Friday, July 23, 2010

University Medical Center in El Paso: Smokers Need Not Apply

The University Medical Center in El Paso, Texas will no longer hire smokers, according to an article in the El Paso Times. According to the article: "'Smokers need not apply,' Jim Valenti, UMC's chief executive officer, said in an interview. 'We care about our associates and their families, and we want to do everything possible to help them have a healthy life. We want to be setting an example.'"

According to hospital spokeswoman Margaret Althoff-Olivas, University Medical Center has a total of 2,310 employees and about 220 - or 9.5% - are smokers.

The Rest of the Story

The rest of the story is that the hospital spokeswoman, who announced the new policy, is herself a smoker and had the policy been in effect when she applied for her job, her application would have been thrown in the garbage.

Is it not ironic that it is a smoker who is announcing to the world that University Medical Center must set an example for the nation by refusing to hire smokers?

By the way, if University Medical Center is so committed to setting a good example and having a healthy workforce, then why is it exempting its 220 current employees who smoke from the policy? Why not just clean house and start with a blank slate of pure nonsmokers? If the only relevant considerations are health care costs and setting a good example, then why retain 220 smokers in your workforce?

Frankly, I don't understand how it sets a "good example" to refuse employment to smokers. In just what way is engaging in employment discrimination a good example? Why is hiring people based on the group to which they belong, when that group membership has no relevance to their qualifications for employment, a good example?

Appropriately, a Texas ACLU spokesperson said: "
We feel that should be a private matter. In general we oppose using what appear to be risky behaviors to make firing and hiring decisions. We feel it should be based on the employee's ability or inability to do the job."

Ironically, it was the smoking spokesperson for University Medical Center who responded: "We're not concerned about it."

How right she is. The University Medical Center is clearly not concerned about civil liberties.

Thursday, July 22, 2010

World Trade Organization to Consider Whether Clove Cigarette Ban Violates International Trade Agreements

The World Trade Organization will consider the issue of whether the ban on clove cigarettes enacted by the U.S. in 2009 violates international trade agreements by discriminating against imported flavored cigarettes (i.e., clove cigarettes) in favor of domestic flavored cigarettes (i.e., menthol cigarettes). The complaint was brought forward by Indonesia, which used to export approximately $15 million of clove cigarettes each year to the U.S.

According to a Reuters article: "Indonesia says the United States is abusing health regulations to shut out clove cigarettes, known as kretek and very popular in the southeast Asian country, while allowing U.S. manufacturers to continue to market menthol cigarettes."

The basis of Indonesia's argument is that flavored cigarettes represent a "like" product manufactured in Indonesia and the U.S. The Family Smoking Prevention and Tobacco Control Act bans clove flavored cigarettes - made in Indonesia - but not the menthol flavored cigarettes manufactured in the U.S.

According to the World Trade Organization: "Indonesia stated that on several occasions it had asked the US to share any studies that demonstrated why clove cigarettes should be banned and not menthol. To date, there had been no response from the U.S."

The primary complaints filed by Indonesia were as follows:

"The Government of Indonesia maintains that banning clove cigarettes in the United States while exempting menthol cigarettes from the ban is inconsistent with the following provisions of GATT 1994:
  • Article III: 4 of the GATT 1994 because the measure provides treatment to an imported product, clove cigarettes, that is "less favorable" than that accorded to a like domestic product, menthol cigarettes.
  • Article XX of GATT 1994 because there is no scientific or technical information indicating that clove cigarettes pose a greater health risk than menthol cigarettes and, as a result, the measure results in arbitrary and unjustifiable discrimination, a disguised restriction on trade, and is more trade restrictive than necessary to achieve a legitimate objective, if one were to exist.
Indonesia also considers the measure to be inconsistent with the following provisions of the TBT Agreement:
  • TBT Article 2.1 because the measure results in treatment that is "less favorable" to imported clove cigarettes than that accorded to a like domestic product, menthol cigarettes.
  • TBT Article 2.2 because there is no scientific or technical information indicating that clove cigarettes pose a greater health risk than menthol cigarettes or that youth smoke clove cigarettes in greater numbers than menthol. As a result, the measure is more trade restrictive than necessary and constitutes an unnecessary obstacle to international trade."
The Rest of the Story

Article 2.1 of the Technical Barriers to Trade (TBT) Agreement states: "Members shall ensure that in respect of technical regulations, products imported from the territory of any Member shall be accorded treatment no less favourable than that accorded to like products of national origin and to like products originating in any other country."

Article 2.2 of the TBT Agreement states: "Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfill a legitimate objective, taking account of the risks non-fulfillment would create. Such legitimate objectives are, inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information, related processing technology or intended end-uses of products."

The central question here is whether menthol and clove cigarettes represent "like products" in that they are both flavored cigarettes. Based on the intent of the Family Smoking Prevention and Tobacco Control Act, there is no question to me that they are like products because they are both flavored cigarettes and there is no qualitative difference relevant to the regulation of the characterizing flavor of a menthol versus a clove cigarette.

If they are like products, then there is no question that the Act treats clove cigarettes less favorably than menthol cigarettes, creates an unnecessary obstacle to trade, and does both of these without any scientific justification. The sole justification for exempting menthol is a political and economic one, not a scientific one. As Article 2.2 of the TBT does not list political or economic considerations as legitimate objectives that would allow a discriminatory trade restriction, it appears that the U.S. is in a difficult position in trying to defend itself from Indonesia's allegation.

Article 3.4 of the General Agreement on Tariffs and Trade (GATT) agreement states that "The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favourable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution or use."

Once again, as long as clove cigarettes and menthol cigarettes are considered to be "like products" by virtue of both being flavored cigarettes under the Act's flavored cigarette provisions, then the Act clearly violates Article 3.4.

Article 20 of GATT does provide exceptions to the above article. Those exceptions include measures "necessary to protect human, animal or plant life or health." They do not include any relevant political or economic exceptions. I therefore cannot see how the U.S. can credibly argue that the Act is not in violation of GATT unless it can point to some scientific or public health justification for the menthol exemption.

As I have argued extensively, there is no public health or scientific justification for the menthol exemption. It was clearly a political compromise that served purely political purposes. In fact, a number of health groups and policy makers have readily acknowledged that the menthol exemption was inserted for political reasons. I have yet to hear any credible scientific or public health justification for such an exemption (which is perhaps the reason why the U.S. has failed to provide any justification to Indonesia).

Even if the U.S. were to argue that the Act falls under the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), I believe the Act still violates that agreement.

Articles 5.4 and 5.5 of the SPS state:
  • "Members should, when determining the appropriate level of sanitary or phytosanitary protection, take into account the objective of minimizing negative trade effects.
  • With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade."
Certainly, banning clove cigarettes while exempting menthol ones doesn't take into account the objective of minimizing trade effects. It actually maximizes trade effects. Furthermore, the Act indeed does make an unjustifiable distinction between clove and menthol cigarettes that results in discrimination.

As I've argued strongly that there is no scientific or public health justification for the menthol exemption, the only possible escape hatch I see for the U.S. is to argue that menthol and clove cigarettes are not "like products." However, I personally disagree with such an assertion because it is clear that under the regulatory framework governing the relevant provision of the Act, clove and menthol cigarettes are qualitatively equivalent as being flavored cigarettes under the law.

The rest of the story, then, is that the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does appear to violate international trade agreements. Specifically, it appears to violate Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures.

Wednesday, July 21, 2010

Wisconsin Medical Society Physician Disseminates Blatantly False Information About Electronic Cigarettes

A physician who is a member of the Board of Directors of the Wisconsin Medical Society and the medical director of the Herrington Recovery Center at Rogers Memorial Hospital in Oconomowoc, Wisconsin has published an op-ed piece in the Milwaukee Journal-Sentinel in which he disseminates blatantly false information about electronic cigarettes.

Not only is the information false, but the true information could easily have been obtained with just about 30 seconds of basic internet searching.

Furthermore, not only is the information false, but it results in material misrepresentation of the true risks of electronic cigarettes.

Dr. Michael Miller writes about electronic cigarettes: "the medium in which the nicotine is vaporized (which is most often ethylene glycol, an ingredient in antifreeze) varies from product to product."

The Rest of the Story

If the medium in which the nicotine in electronic cigarettes is vaporized were ethylene glycol, then electronic cigarettes would be an extremely toxic product. In fact, there would probably have been many reported deaths or serious adverse effects of electronic cigarettes because ethylene glycol is toxic. It is indeed the most common chemical used in antifreeze and as most consumers know, it is toxic.

Fortunately, the medium in which the nicotine in electronic cigarettes is vaporized is almost universally propylene glycol, which is generally regarded as safe as a food additive by the FDA. Propylene glycol is commonly used as a solvent for pharmaceuticals.

Importantly, this false claim by Dr. Miller is not just an irrelevant mistake. It is highly relevant because it in fact conveys a completely false implication: that electronic cigarettes are highly toxic and that vaping is equivalent to ingesting antifreeze. On the contrary, propylene glycol is generally regarded as safe, is widely used in medications, and there is no evidence nor any reason to believe that it presents any safety risk to electronic cigarette users.

What's most troubling about this story is not the simple fact that the physician made a blatant error resulting in public misinformation. What is most troubling is the fact that he apparently was so zealous about making a pre-conceived point that he failed to do even the most basic of research to find out what is in the product he was determined to attack.

When you write an op-ed, you essentially become an authority on the topic you are writing about and you take on the responsibility of researching the topic to make sure that you are providing accurate information. The difference between ethylene glycol and propylene glycol is a huge one. Making such a mistake in giving advice to an individual patient could be fatal - literally. Making the identical mistake in giving advice to a large population of people is highly irresponsible.

Hopefully, Dr. Miller will provide a retraction and correction to this op-ed piece and apologize for misinforming the public about the true relative health risks of electronic cigarettes.

Tuesday, July 20, 2010

If You're Banning Chocolate and Banana in Cigarettes, Then Why Not Licorice, Brown Sugar, Caramel, Lemon Oil, Lime Oil, and Scotch Spearmint Oil?

Yesterday, I argued that the TPSAC, in being asked to evaluate whether or not it made sense to exempt menthol from the ban on cigarette flavorings, must consider the central question of whether menthol enhances the taste, and therefore the appeal of cigarettes, especially to youth. Today, I extend that reasoning by arguing that menthol is not unique and that there are more than a hundred similar flavorings added to cigarettes that enhance the taste and appeal of the product. Based on the reasoning used to ban cigarette flavorings like chocolate, vanilla, and strawberry, each of these other flavorings must also be banned.

R.J. Reynolds, for example, acknowledges that each of the following 130 additives is used as a flavoring agent in some of its cigarette brands to enhance the taste and therefore the appeal of the product.

  • Acetic Acid
  • Acetoin
  • Acetophenone
  • 2-Acetylpyrazine
  • 3-Acetylpyridine
  • Amyl Butyrate
  • Amyl Octanoate
  • Amyris Oil
  • trans-Anethole
  • Anisic Aldehyde
  • Ascorbic Acid
  • Balsams, Peru
  • Beeswax Resinoid
  • Benzaldehyde
  • Benzaldehyde Glyceryl Acetal
  • Benzoic Acid
  • Benzyl Alcohol
  • Benzyl Benzoate
  • Benzyl Cinnamate
  • Bornyl Acetate
  • Brown Sugar
  • Butanoic Acid, 3-Methyl-, 4-Methylphenyl Ester
  • Butanol, 3-Methyl-, Benzoate, 1-
  • Butyl Alcohol
  • n-Butyl Isovalerate
  • Butyric Acid
  • Caramel Color
  • Caramel (Plain)
  • Cardamon Oil
  • Carob Bean Extract
  • Carrot Seed Oil
  • l-Carvone
  • Caryophyllene
  • Caryophyllene Oxide
  • Celery Seed Oil
  • Chicory Extract
  • Cinnamaldehyde
  • Cinnamon Bark Oil
  • Citral
  • Citric Acid
  • Citronella Oil
  • Clary Sage Oil
  • Cocoa (Extract, Powder, Extractive, Tincture, Distillate, Absolute)
  • Coffee Beans, Ground
  • Coriander Oil
  • Corn Syrup
  • Damascenone
  • Davana Oil
  • delta-Decalactone
  • gamma-Decalactone
  • Decanoic Acid
  • Dextrose
  • Diammonium Phosphate
  • Diethyl Malonate
  • 2,6-Dimethoxyphenol
  • Dimethyl Benzyl Carbinol Butyrate
  • Dimethyl Sulfide
  • 3,4-Dimethyl-1,2-Cyclopentadione
  • 4,5-Dimethyl-3-Hydroxy-2,5-Dihydrofuran-2-one
  • 2,5-Dimethylpyrazine
  • Dodecahydro-3A,6,6,9A-Tetramethylnaptho-(2,1-b)-Furan
  • delta-Dodecalactone
  • gamma-Dodecalactone
  • Ethyl Acetate
  • Ethyl Benzoate
  • Ethyl Butyrate
  • Ethyl Caproate
  • Ethyl Cyclotene
  • Ethyl Decanoate
  • Ethyl Heptanoate
  • Ethyl Levulinate
  • Ethyl Maltol
  • Ethyl Methyl Phenyl Glycidate
  • Ethyl Myristate
  • Ethyl Nonanoate
  • Ethyl Octanoate
  • Ethyl Pentanoate
  • Ethyl Phenylacetate
  • 3-Ethyl Pyridine
  • Ethyl Vanillin
  • 4-Ethyl-2-Methoxy-Phenol
  • Ethyl-2-Methylbutyrate
  • 2-Ethyl-3,5(or 6)-Dimethylpyrazine
  • 5-Ethyl-3-Hydroxy-4-Methyl-2(5H)-Furanone
  • 2-Ethyl-3-Methylpyrazine
  • Eucalyptol
  • Fenugreek Absolute/Extract
  • Fenugreek Seed
  • Furaneol
  • Geraniol
  • Geranium Bourbon Oil
  • Geranyl Acetone
  • Glycerides, mixed decanoyl and octanoyl
  • Guaiacol
  • Helichrysum Absolute
  • gamma-Heptalactone
  • Heptanoic Acid
  • omega-6-Hexadecenlactone
  • gamma-Hexalactone
  • Hexanal
  • Hexanoic Acid
  • 3-Hexanoic Acid
  • 1-Hexanol
  • 2-Hexen-1-ol
  • cis-3-Hexen-1-yl Acetate
  • cis-3-Hexenol
  • Hexyl Acetate
  • Hexyl Phenylacetate
  • Hydroxyphenyl)-Butan-2-one, 4-(para-
  • Invert Sugar
  • alpha-Ionone
  • beta-Ionone
  • alpha-Irone
  • Isoamyl Acetate
  • Isoamyl Butyrate
  • Isoamyl Isovalerate
  • Isobutyl Phenylacetate
  • 2-Isobutyl-3-Methoxy Pyrazine
  • Isobutyraldehyde
  • Isovaleraldehyde
  • Isovaleric Acid
  • Jasmine Absolute
  • Labdanum Absolute
  • Lactic Acid
  • Lauric Acid
  • Lemon Oil
  • Lemongrass Oil
  • Levulinic Acid
  • Licorice
  • Licorice Extract Powder
  • Lime Oil
  • Linalool
  • Linalool Oxide
  • Linalyl Acetate
  • Linoleic Acid
  • Lovage Root
  • Maltol
  • Mate Extract
  • para-Mentha-8-Thiol-3-one
  • Menthol
  • l-Menthone
  • 2-Methoxy-3-Methyl-Pyrazine
  • 2-Methoxy-4-Methylphenol
  • Methyl Dihydrojasmonate
  • Methyl Linoleate/Methyl Linolenate
  • 2-Methyl Pentanoic Acid
  • Methyl Salicylate
  • trans-2-Methyl-2-Butenoic Acid
  • Methyl-2-Furoate
  • Methyl-2-Pyrrolyl Ketone
  • 2-Methyl-3((5 or 6)Furfurylthio)pyrazine
  • 6-Methyl-3,5-Heptadien-2-one
  • 6-Methyl-5-Hepten-2-one
  • 4-Methylacetophenone
  • 2-Methylbutyric Acid
  • Methylcyclopentenolone
  • 2-Methylpyrazine
  • 5-Methylquinoxaline
  • 3-Methylvaleric Acid
  • Myristic Acid
  • Myrrh Absolute
  • Myrrh Extract
  • Myrrh Oil
  • Nerol
  • Neroli Bigarade Oil
  • Nerolidol
  • 2,6-Nonadien-1-ol
  • gamma-Nonalactone
  • Nonanoic Acid
  • gamma-Octalactone
  • Octanal
  • Octanoic Acid
  • 1-Octen-3-ol
  • 2-Octenal, (E)-
  • Olibanum Oil
  • Orange Oil
  • Orange Oil Terpenes
  • Orange Sweet Terpeneless Oil
  • Orris Root Extract
  • Palmitic Acid
  • Patchouli Oil
  • Patchouly Absolute
  • omega-Pentadecalactone
  • 2,3-Pentanedione
  • Pepper Oil, Black
  • Peppermint Oil, Terpeneless
  • Peru Balsam Oil
  • Phenyl-2-Propenoic Acid Ethyl Ester, 3-
  • Phenyl-2-Propenoic Acid, 3-
  • Phenylacetaldehyde
  • Phenyl Acetic Acid
  • Phenethyl Acetate
  • Phenethyl Alcohol
  • alpha-Pinene
  • Piperonal
  • Potassium Carbonate
  • Potassium Sorbate
  • Propyl Acetate
  • Rose Oil (Turkish)
  • Rosemary Oil
  • Salicylic Aldehyde
  • Sandalwood Oil, Yellow
  • Sodium Citrate
  • Scotch Spearmint Oil
  • Sucrose
  • alpha-Terpineol
  • alpha-Terpinyl Acetate
  • 5,6,7,8-Tetrahydroquinoxaline
  • 2,3,5,6-Tetramethylpyrazine
  • Thymol
  • para-Tolualdehyde
  • Triethyl Citrate
  • 3,5,5-Trimethyl-1,2-Cyclohexanedione
  • 2,6,6-Trimethyl-2-Cyclohexene-1, 4-Dione
  • 4-(2,6,6-Trimethylcyclohex-1-enyl) but-2-en-4-one
  • 2,3,5-Trimethylpyrazine
  • delta-Undecalactone
  • gamma-Undecalactone
  • 2-Undecanone
  • Urea
  • Valerian Root Oil
  • gamma-Valerolactone
  • Vanilla Oleoresin
  • Vanillin
  • Veratraldehyde
  • Vetiver Oil
  • Violet Leaves Absolute

  • If you look at Camel cigarettes in particular, you'll note that the following flavorings are added to enhance the taste and appeal of the product -- the first four are present in nearly all Camel sub-brands and the remainder are present in certain sub-brands:
    • Brown sugar
    • High fructose corn syrup
    • Cocoa
    • Licorice
    • Honey
    • Sucrose
    • Menthol
    How can it make any sense for the federal government to ban chocolate, vanilla, strawberry, pineapple, coconut, and banana flavorings -- which are almost never used in cigarettes -- but to allow cigarette companies to put sugar, cocoa, licorice, and honey in cigarettes to improve their taste and enhance their appeal to children?

    Certainly, if you're not going to allow banana, then you shouldn't allow honey. If you're not going to allow pineapple, then you shouldn't allow sugar. If you're not going to allow mint, then you sure as heck shouldn't allow licorice. And if you're not going to allow chocolate, then you shouldn't allow brown sugar.

    To be clear, I'm not stating that I agree with the original decision to ban flavorings; however, the regulatory framework set up by the anti-smoking groups essentially asks the FDA to regulate the ingredients in cigarettes that enhance its appeal to youth. Thus, the FDA seems to have little choice but to ban all the additives in cigarettes. After all, there is no way the FDA can justify a ban on pineapple but allow lemon and lime oil, caramel, brown sugar, peppermint oil, vanillin, licorice extract powder, and scotch spearmint oil to be added to cigarettes to improve their taste and enhance their appeal among potential youth smokers.

    Perhaps more potently, a failure to ban lemon, lime, spearmint, and peppermint oil, vanillin, brown sugar, cocoa powder, caramel, and licorice would be completely inconsistent with the public statements made by the FDA and by prominent HHS officials.

    For example, the FDA itself has boasted that: "The Tobacco Control Act prohibits the manufacture, distribution, and sale of those cigarettes [flavored cigarettes] in order to protect our kids...". Well, if a prohibition on flavored cigarettes is necessary to protect kids, then it looks like the FDA has no justification for failing to also ban a host of other flavorings -- particularly since these are flavorings which the cigarette companies actually use.

    Furthermore, the FDA Commissioner stated that: "These flavored cigarettes are a gateway for many children and young adults to become regular smokers." So if flavored cigarettes are a gateway for children to become regular smokers, wouldn't the FDA want to ensure that lemon, lime, spearmint, peppermint, brown sugar, caramel, cocoa, and licorice aren't also added to cigarettes to give them a taste that is more likely to appeal to kids?

    And the icing on the cake is that the Assistant Secretary for Health and Human Services stated: "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily." If flavorings in cigarettes are what attract and allure kids into a lifetime of addiction and breaking that cycle will stop 3,600 young people from smoking every day, then it seems imperative that the FDA ban all flavorings from cigarettes, not just the ones which are not ever used.

    I don't believe for a minute that the Assistant Secretary of HHS, FDA Commissioner, or anyone at FDA is going to recommend a ban on all of these flavorings. Why? Because I don't believe that they are actually sincere about their desire to stop 3,600 kids a day from smoking. I think their statements were a purely political stunt that was not based in reality.

    We'll see. Let's see whether the same policy makers who made those statements about the dire need to get flavors out of cigarettes actually follow through by getting the flavors out of cigarettes. In the mean time, I stand by my statement. I truly believe this is all about politics, and not about science, nor about actually improving the public's health by preventing 3,600 young people every day from starting to smoke. The Family Smoking Prevention and Tobacco Control Act is all about protecting and institutionalizing cigarette smoking, not reducing it.

    Monday, July 19, 2010

    IN MY VIEW: FDA Tobacco Panel is Asking All the Wrong Questions on Menthol, and Wasting Incredible Time and Resources

    In an incredible display of wasted time and resources by a federal bureaucracy, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) is asking all the wrong questions about menthol in its deliberations about whether menthol should be included in the federal ban on flavored cigarettes.

    The background here is essential: The Congress enacted a ban on flavored cigarettes, but exempted menthol for purely political, not scientific reasons. As a last minute compromise to save the bill because the Congressional Black Caucus was threatening to withdraw support over the menthol exemption, the bill's supporters hastily stuck in a provision that would require the FDA to revisit the issue of menthol.

    Surely, in light of this background, the relevant question before the TPSAC is whether or not the same justification that led to the ban on flavored cigarettes also applies to menthol. In other words, the question is whether or not there is a justification for an exemption for menthol cigarettes from the flavoring ban. To look at this issue from any other perspective is ignorant of the legislative history and of the reason why the FDA was asked to look at menthol in the first place.

    The specific reason why the FDA was asked to look at menthol was that the Black Congressional Caucus had questioned the justification for exempting menthol from the flavoring ban. I believe, therefore, that the FDA ought to look at the issue from that precise perspective. Does the reasoning which supports a ban on flavored cigarettes also support a ban on menthol cigarettes?

    To look at the issue from any other perspective is, I believe, inappropriate.

    So let's examine the reasoning that was used to support the ban on flavored cigarettes. The following 5 points are critical:

    1. The ban on flavored cigarettes was not supported by a contention that flavored cigarettes are more harmful than other cigarettes.

    There is no evidence that flavored cigarettes are any more harmful than other cigarettes and I am not aware of any anti-smoking group or policy maker that has made such an assertion. The relative harm of flavored cigarettes simply did not enter the picture and is not part of the reasoning for the ban on flavored cigarettes.

    2. The ban on flavored cigarettes was not supported by a contention that flavored cigarettes are more addictive, or more difficult to quit smoking, than other cigarettes.

    There is no evidence that flavored cigarettes are any more addictive or harder to quit smoking than other cigarettes and I am not aware of any anti-smoking group or policy maker that has made such an assertion. The relative addictive potential of flavored cigarettes simply did not enter the picture and is not part of the reasoning for the ban on flavored cigarettes.

    3. The ban on flavored cigarettes was not supported by a claim that youth are more likely to smoke these products.

    There is strong evidence that the opposite is true: youth are far less likely to smoke flavored cigarettes than the non-flavored cigarettes on the market: Marlboros, Camels, and Newports. Between 2007 and 2010, the market share for flavored cigarettes among youth was dismally small, and no flavored cigarette brand manufactured by any Big Tobacco company was used by youths.

    4. The ban on flavored cigarettes was not supported by a claim that flavored cigarettes are targeted specifically to youth.

    There is no evidence that, since 2007, any tobacco companies have been targeting their marketing of flavored cigarettes toward youth. In fact, the few flavored cigarette brands on the market during this most recent time period appeared to be marketing toward adult smokers. On the basis of marketing patterns, it is the non-flavored cigarettes which would have been the primary concerns, not the few flavored ones.

    5. The one and only one consideration which supported the ban on flavored cigarettes was that these flavorings enhance the taste and therefore the appeal of these products, especially to youth.

    This, in fact, is the sole factual (or "scientific") support offered for the ban on flavored cigarettes. By adding flavors like chocolate, strawberry, coconut, or pineapple to their cigarettes, manufacturers will make their products taste better and therefore be more appealing to consumers, especially youth who are probably more sensitive to any harshness in tobacco.

    Therefore, the central question that comes before TPSAC is not: (1) whether menthol cigarettes are more harmful than others; (2) whether menthol cigarettes are more addictive or more difficult to quit than others; (3) whether menthol cigarettes are more likely to be smoked by youth; or (4) whether menthol cigarettes are specifically marketed toward youth.

    Instead, the central question is simply: does menthol enhance the appeal of cigarettes, especially among youth?

    If it does, then the same reasoning that Congress used in its decision to ban chocolate and strawberry flavorings would also apply to menthol.

    The FDA cannot escape this. If it presents the TPSAC with a different question than whether menthol enhances the appeal of cigarettes, then it is using different criteria to assess menthol than was used to assess other cigarette flavorings. This would not only be inappropriate, but it would be a travesty of justice because it would constitute institutional racism to use a much different and more rigorous standard to make decisions about a flavoring which appeals most particularly to African Americans than about flavorings which appeal most particularly to whites.

    The TPSAC cannot escape this either. If it asks different questions than whether menthol enhances the appeal of cigarettes, then it is using different criteria to assess menthol than was used to assess other cigarette flavorings. Again, this would not only be inappropriate, but it would be a travesty of justice because it would constitute institutional racism to use a much different and more rigorous standard to make decisions about a flavoring which appeals most particularly to African Americans than about flavorings which appeal most particularly to whites.

    Having established that the central question the TPSAC needs to answer is whether menthol enhances the appeal of cigarettes, especially among youth, we are now ready to consider the rest of the story.

    The Rest of the Story

    The rest of the story is that the TPSAC is asking all the wrong questions and that the FDA itself appears to be presenting TPSAC with the wrong set of questions and the wrong data. The information being sought by the TPSAC is largely the wrong set of information. The data being presented to the TPSAC is the wrong data.

    Simply put, the question of whether menthol enhances the appeal of cigarettes, especially to youth, is a near no-brainer. Of course it enhances the appeal of cigarettes! The companies themselves admit that. R.J. Reynolds testified that menthol adds a "cooling sensation" and "minty flavor" to cigarettes. R.J. Reynolds also acknowledges, on its web site, that menthol is used to "impart or help impart, or enhance or modify, a taste or aroma" in cigarettes.

    That menthol is used to, and succeeds in, enhancing the taste of cigarettes is therefore a matter of public record at this point. There is no debate or dispute about the issue. Since menthol enhances the taste of cigarettes, it obviously enhances the appeal of the product. How could it not? It is obvious that people prefer products that taste better.

    So the rest of the story is that the TPSAC is piddling and twiddling around the margins of the central issue, wasting incredible time and resources, when what it clearly needs to do is entertain the focused question of whether menthol, like chocolate, strawberry, vanilla, banana, and pineapple flavorings, enhance the taste and therefore the appeal of cigarettes, especially to youth. This is a matter that could be dispensed with quickly, based on the public record alone, with no speculation or long, two-day meetings and one year of deliberation necessary. No hour long testimony from cigarette companies and tobacco control scientists and researchers is needed. There is no need to waste the taxpayers' money as is being done when the question before the Committee is such a simple one. There is no need for a detailed Agency report and for a review of thousands of pages of research studies.

    By the way, I do not disagree with the tobacco companies' statements to the Committee that the scientific evidence fails to support the conclusion that menthol cigarettes are more hazardous or more addictive than non-menthol cigarettes. But if you ask an irrelevant question, you're going to get an irrelevant answer. Sadly, the Committee has responded by asking for even more evidence regarding these irrelevant questions.

    According to an NPR story: "
    it isn't menthol's taste that is under scrutiny at the hearing." Well it should be! After all, that's why flavored cigarettes were banned and that's why the FDA was asked by Congress to examine the menthol issue in the first place. The issue is precisely whether menthol's taste enhances the appeal of these cigarettes, especially to youth, thus contributing towards the uptake of smoking these menthol brands among new youth smokers. And despite all the collective experience on the Advisory Committee, they don't seem to understand that, as one might say: "It's the taste, stupid!"

    Of course, as I have also argued, there are hundreds of other flavorings which are also used to enhance the taste, and thus the appeal of cigarettes, and so the reasoning behind the Family Smoking Prevention and Tobacco Control Act also supports the elimination of these flavoring additives as well.

    All of this should highlight for you the absurdity of this entire approach to the tobacco problem. You don't address the problem of cigarettes by asking the Food and Drug Administration to develop "safety standards" for a product that kills more than 400,000 people each year. You don't ask the FDA to approve such a product. You don't ask the FDA to deceive the public by pretending that it is setting science-based standards which will result in a safer product.

    In my frank opinion, the FDA should go back to the drawing board. Save the taxpayers the wasted expense of spending so much time and effort piddling and fiddling over issues that are not relevant to the actual question at hand. Examine the scientific literature to identify the tried and true methods of decreasing smoking which we know work. Put the money into aggressive anti-smoking media campaigns, statewide programs, smoking cessation resources and support -- including the Pathways to Freedom guide for African American smokers trying to quit and other culturally specific programs and interventions -- and community mobilization, organization, and tobacco control infrastructure.

    Of course, we know this will not happen. No one in the mainstream of tobacco control is willing to ever admit that they made a mistake. So given that we are stuck with the disaster that is the Family Smoking Prevention and Tobacco Control Act, the least I think the public can ask for is that FDA and TPSAC not participate in institutional racism by using different criteria to assess flavorings that are particularly preferred by African Americans versus white Americans. The least we can ask is that they not waste our taxpayer dollars on asking the exact wrong questions.

    Thursday, July 15, 2010

    FDA Regulatory Scheme is Severely Flawed and Actually Requires that All Cigarette Additives Be Eliminated

    In this post, I explain why the anti-smoking groups and policy makers who crafted and supported the Family Smoking Prevention and Tobacco Control Act have dug a hole for themselves by establishing a regulatory scheme that is based not on science, but on politics. In particular, the ban on cigarette flavorings has established as a criterion for judging tobacco ingredients whether or not a particular ingredient enhances the appeal of the product. There is no evidence that flavored cigarettes are more harmful than regular cigarettes. Clearly, the criteria used to ban these cigarette brands was that no additive should enhance the appeal of the product, especially to young people. As I will show, by this criterion, all cigarette additives now need to be banned. This is an absurd result which will not, I argue, necessarily yield any significant public health benefits. But it does demonstrate the absurdity of this entire approach to tobacco product regulation.

    The Rest of the Story

    Here is the basic argument: Since the criterion being used by Congress in banning flavored cigarettes was that tobacco companies should not add any ingredients to their products which enhance their appeal and help them market the products successfully, especially to youths, I believe that all cigarette ingredients fall into this category. By definition, ingredients are not added to a product unless they ultimately enhance the appeal of the product and improve the bottom line: product sales. It would be a waste of expenditures for tobacco companies to spend large amounts of money purchasing chemicals if the use of those chemical additives played no role in enhancing product appeal.

    Therefore, I believe that the FDA Tobacco Products Scientific Advisory Committee has no choice but to recommend a ban on all cigarette additives. The charge given to the FDA by Congress clearly was to eliminate ingredients that enhance the appeal of cigarettes to consumers. Candy and fruit flavorings are actually the least important of the additives used to enhance product appeal. Cigarette companies use a host of additives to enhance the taste and appeal of their products. Given the regulatory framework of the FDA tobacco legislation and the fact that Congress has banned fruit flavored cigarettes based on a desire to disallow tobacco companies from enhancing the appeal of their products, I believe that there is no justification for the FDA to allow any additives to be used in the production of cigarettes.

    For example, R.J. Reynolds readily acknowledges that it uses brown sugar to “enhance tobacco product quality by balancing sensory attributes and developing certain desired taste and/or flavor characteristics,” and that additives such as butyl alcohol, ethyl vanillin, ethyl phenylacetate, and methyl dihydrojasmonate are “used to impart or help impart, or enhance or modify, a taste or aroma” in some of its cigarettes. This is precisely the same function that R.J. Reynolds cites as the reason for the addition of menthol to some of its cigarette brands. There are literally hundreds of flavorings used by tobacco companies to enhance the appeal of their products. The criterion established by Congress in banning the use of chocolate, strawberry, and banana – that cigarettes should not contain any flavoring that enhances the product’s appeal to young people - applies equally to the hundreds of other flavors that are added to cigarettes.

    I believe that a “scientific” approach to the issue at hand would look broadly at all of the additives used to enhance the flavor and appeal of cigarettes, rather than just at a few hand-chosen ones, in order to develop the most appropriate, science-based policy. And in my view, based on the criteria clearly established in the Family Smoking Prevention and Tobacco Control Act, I believe that the FDA therefore has no choice but to ban the use of all additives in cigarettes, since there are hundreds of additives which the tobacco companies acknowledge play essentially the same role as menthol. All additives are used to enhance the appeal of the product; they would not be in the product if the companies did not think that they enhanced product appeal. Under the regulatory framework set out by the Family Smoking Prevention and Tobacco Control Act, the FDA has no choice but to ban the use of all of these additives.

    I note that the banning of all cigarette additives will not result in a safer cigarette. There are existing cigarettes on the market – such as Winston and American Spirit – which contain no additives. I do not believe there is any evidence to support a contention that the removal of all additives from cigarettes will result in a safer product. In addition to banning all additives, the FDA should therefore conduct a public education campaign to inform consumers that the changes it is requiring in cigarettes will not make these products any safer.

    Finally, I note that the removal of all additives from cigarettes will not necessarily result in any decrease in adult or youth smoking. Winston cigarettes, which do not contain any additives, are still popular among many smokers. Cigarette companies can find ways to alter the tobacco blends and use reconstituted tobacco in ways that produce cigarettes which still appeal to consumers. That the removal of all additives – which I believe is consistent with the approach taken by the Family Smoking Prevention and Tobacco Control Act – will not necessarily produce any public health benefit demonstrates the absurdity of the approach that was taken by the policy makers and anti-smoking groups who supported this legislation.

    Regulation of the content of a product that is inherently deadly is not an appropriate approach to the problem. There is no such thing as a “safety standard” for cigarettes. Until they acknowledge this, the FDA and the anti-smoking groups will lead us down a road of bureaucratic fumbling that may feel good and generate positive public opinion, but it will accomplish nothing in terms of protecting the public’s health. The money being wasted on bureaucratic study of ingredients in tobacco would be better spent on a public education and media campaign, which has been demonstrated to be one of the most effective approaches to reducing tobacco use.