Tuesday, February 27, 2007

Written Statement of Michael Siegel, MD, MPH, Regarding the FDA Tobacco Legislation - Submitted to Senate HELP Committee - February 27, 2007

Written Statement of Michael Siegel, MD, MPH

Regarding the Family Smoking Prevention and Tobacco Control Act

Submitted to the U.S. Senate Committee on Health, Education, Labor, & Pensions

February 27, 2007

Michael Siegel, MD, MPH


Social and Behavioral Sciences Department

Boston University School of Public Health

715 Albany Street, TW2

Boston, MA 02118

I am a Professor in the Social and Behavioral Sciences Department at the Boston University School of Public Health and as a physician trained in preventive medicine and public health, I have been a tobacco control researcher, practitioner, and teacher for the past 21 years. I spent two years at the Office on Smoking and Health at the Centers for Disease Control and Prevention (CDC), and I am quite familiar with the issues involved in federal tobacco control regulation and policy. I was at CDC during Dr. David Kessler's original investigation into the possibility of FDA claiming jurisdiction over tobacco products, and helped advise FDA at that time. I have published more than 60 peer-reviewed articles in the medical and public health literature, most concerning tobacco policy. I have testified as a witness for the plaintiffs in seven tobacco-related lawsuits, including the Engle case which resulted in an unprecedented $145 billion verdict in favor of the plaintiffs. I have testified in more than 50 local and state hearings in support of smoke-free bar and restaurant laws. In summary, I am about as anti-smoking as one can be.

Proponents of the proposed FDA tobacco legislation have argued that this bill would end special protections for the tobacco industry, protect the public’s health, reduce tobacco use, make cigarettes safer, and save lives. However, a detailed analysis of the actual provisions of the legislation makes it clear that quite the opposite is true. The bill would provide unprecedented special protections for Big Tobacco – protections not enjoyed by any other industry whose products are regulated by the FDA. The bill would harm the public’s health at the expense of protecting the financial interests of the largest tobacco companies. The bill would likely increase tobacco use, create a false impression that cigarettes are safer, end the prospects for a truly safer cigarette, and in the long run, result in an increased number of deaths from tobacco use. Supporters of the bill are full of rhetoric, but when you take the time to actually examine the bill and the regulatory framework it establishes, you see that this legislation is in the best interests of the nation’s leading tobacco company – Philip Morris; it is not in the best interests of protecting the public’s health.

1. The Regulatory Scheme Established by the Legislation is Pure Lunacy

The Bill Would Create the Illusion of Safer Cigarettes Without Any Evidence that the Product Is, or Can be Made Safer

The system of tobacco product safety standards set up by the bill is pure lunacy. Although the rhetoric by groups like the Campaign for Tobacco-Free Kids sounds great, the truth is that there is no evidence that these standards would actually result in a safer product.

The problem is that we simply do not know which of the constituents in tobacco smoke, and at what quantities, are responsible for what diseases. So the Campaign for Tobacco-Free Kids can talk all they want about how FDA will be able to reduce levels of certain toxins and produce a safer cigarette, but that's a pipe dream. It would take difficult to conduct, long-term epidemiologic studies, where you'd have to follow smokers of conventional vs. new products for 10-20 years, before you could have an answer to this question. But in the mean time, we wouldn't know what the risks are - or even if the risk could be decreased.

Essentially, the bill gives the FDA a mandate which it cannot carry out. The only way to know whether any particular reductions in specific smoke constituents would result in a safer product would be to carry out long-term epidemiologic studies, using smokers as guinea pigs. Perhaps some would view that as acceptable because the product is dangerous anyway. However, the problem is that smokers are going to naturally assume that these products are safer - and we won't know that is true. This legislation would greatly deceive smokers into thinking that the product is safer, when it may well not be any safer at all, and could potentially be more hazardous.

Unfortunately, we simply do not have any idea whether it is even possible to reduce the toxicity of cigarettes by reducing the levels of specified components.

The entire approach is flawed, because if you want safer cigarettes, you need to use the free market approach to set up competition between the companies for a safer product. This legislation does the opposite. It takes away the free market completely and puts all decisions into the hands of FDA. But it gives the FDA a mandate which sets up impossible standards that could never be met for new products. What it really does is ensure that existing products will be institutionalized and protected from competition. This, indeed, is the reason why Philip Morris supports the bill, and all the smaller companies oppose the bill. What the smaller companies despise is the removal of any serious chance to compete in the market - and largely, the market we are talking about is potentially safer products.

Philip Morris wants to freeze the market as is, so that Marlboro - one of the highest risk products imaginable - will be able to dominate the market, without any serious competition from potentially safer products which could advertise themselves as being safer than Marlboro and thus gain market share among the "health-conscious" segment of smokers who are looking to reduce their risks while still satisfying their demand for cigarettes.

If you really think about it, you'll see that the approach of trying to reduce the levels of specific smoke constituents is complete lunacy. When you have no idea which constituents, in what combination, and at what concentrations, cause which diseases that are associated with smoking, then it is impossible to produce a cigarette that you know will be safer simply by mandating a reduction in the levels of various smoke constituents.

The one thing you will never hear the supporters of this legislation do is estimate the number of lives they think this legislation will save. All they can do is talk about "countless" lives being saved. And they are quite correct. The lives are countless. You cannot count them because they do not exist.

It is estimated, for example, that there are over 60 compounds in tobacco smoke which cause cancer. So what sense does it make to require the companies to take out two or three of them? What if they take out the wrong ones? What if the actual compound which causes most of the cancer is not one of those chosen to be removed? What if smokers believe that this is a safer product and start smoking more? This approach could actually kill people, rather than save lives.

And it could also kill people by reducing youths' perceptions of the hazards of cigarette smoking. If youths are led to believe –correctly - that the FDA now regulates every ingredient of the cigarette and that – incorrectly - because of this, countless lives will be saved, does it not make sense for these kids to infer that cigarettes are not as bad as they used to be? We know for a fact that any decline in the perceived harm of cigarettes results in an increase in youth smoking. So the proposed FDA legislation could well kill more people than it saves.

The bottom line is that there is no point in giving the FDA regulatory authority over cigarettes unless there is evidence that there is something that the FDA could do to regulate cigarettes to unequivocally make the products safer. To start the FDA on a crapshoot where they would choose random smoke constituents to reduce or eliminate in cigarettes makes no public health sense. It will give an FDA stamp of approval to tobacco products, but without actually making them any safer.

2. The Legislation Would Be a Death Knell for the Development of Truly Safer Tobacco Products

The Bill Would Make it Impossible for Tobacco Companies to Market Truly Reduced Risk Cigarettes and Would Eliminate Any Incentive to Develop Such Products

The bill puts a death knell to harm reduction as a strategy. It prohibits the marketing of any newer, safer cigarette, unless it meets FDA approval. But here's the catch - in order to meet FDA approval, you would have to prove that the product improves health, both on an individual and a population level. To do that, you'd have to conduct epidemiologic studies in which smokers were followed for 10-20 years. And you'd have to hope that they stuck with their products (conventional vs. new), without switching, for the entire period. In short, this is impossible. Thus, this legislation would make it impossible to produce and market safer cigarettes. It essentially takes all the incentive away. No cigarette company is going to want to spend millions of dollars on testing and producing a safer cigarette when they know it is going to be virtually impossible for them to ever market it.

And this is precisely why Philip Morris favors this legislation. Philip Morris realizes that the bill sets up an impossible standard for new products. Thus, it ensures that the existing market is basically frozen - obviously, this is a dream come true for the company with the largest current market share, because it stifles competition.

The only way to get safer cigarettes would be to allow the free market to produce them - not by creating this elaborate regulatory scheme.

In fact, if you actually read the legislation [see section 901(g)(1)], you'll see that it is not just virtually impossible to meet the standards required to market a reduced risk product, it is actually impossible. In order to prove that a product reduces health risks as it is actually used, both on an individual and population basis, you'd have to demonstrate the results of a study in which the product is marketed the way it would be marketed in real life - that is, as a reduced risk product. But you can't market it as a reduced risk product until you've proven that it reduced risks.

This is truly a catch-22. You cannot market a product as reduced risk until you've proven it reduces risk, but you cannot possibly prove that it reduces risk until you've marketed it as such.

Thus, the proposed legislation not only represents a de facto end to the prospect of truly safer products - it represents an actual death knell for any meaningful harm reduction strategy.

The critical flaw in the proposed legislation is section 911(g)(1). This is the Modified Risk Product section of the bill.

The Modified Risk Product section of the proposed FDA legislation would make it virtually impossible for modified risk products to enter the market, while at the same time, allowing reduced exposure products to essentially be falsely marketed as reduced risk products (thus institutionalizing the very problem that the health organizations have expressed so much concern about).

Here are the specific problems:

1. The legislation lists several criteria for achieving approval of a modified risk product. The most important are the following: "the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will--`(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and `(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(1)(A), the (A) clause above places an insurmountable obstacle in the path of approval of modified risk products. In order to demonstrate that the product, as actually used by consumers, will significantly reduce the risk of tobacco-related disease to individual users, large-scale, long-term epidemiologic studies are necessary. Even ignoring the requirement under 911(g)(1)(B), the (B) clause above (which itself appears to introduce an insurmountable obstacle), the bill as currently written precludes any harm reduction approach to tobacco control both by making it impossible for such products to meet the conditions for approval and by eliminating any incentive (especially economic) to develop such products. Thus, the bill may have the exact opposite effect that many believe it should have. It protects the existing high-risk products on the market.

It is critical for the public and policy makers to understand the ramifications of section 911(g)(1). In order to market a reduced risk product, a cigarette company would have to demonstrate that the product, as actually used by smokers, would substantially reduce the actual risk of disease among individual tobacco users.

There is only one way to do this. And that is to conduct a long-term epidemiologic study in which one compares the disease risk of the modified product with that of a comparison product over a long time period and among a large population of smokers.

There are all kinds of complications with conducting such a study. First, it would be tremendously expensive. Second, it would take, at a minimum, 10-20 years to follow the smokers long enough to monitor changes in disease. For cancer risks in particular, you would have to follow smokers for about 20 years before you would be able to draw definitive conclusions regarding any reductions in risk.

Third, there are all kinds of research complications that would make it difficult to draw accurate conclusions. The only way to credibly demonstrate a reduction in risk would be to conduct a randomized clinical trial, where smokers were randomized to either smoke conventional cigarettes or the putative reduced risk cigarettes. But conducting a randomized trial of smoking would be unethical; such a study is impossible.

The best that could be hoped for is a natural experiment type of study in which a product is "test-marketed" and that population of smokers (i.e., guinea pigs) are monitored for 10-20 years. But this is a catch-22. How can you test-market the product if you need to obtain FDA approval before you can test-market it? The only way you could do this would be to market the product as a conventional cigarette (not let anyone know that it is a potentially reduced risk product). But to do that, you would destroy the study, because it is your obligation to demonstrate that as actually used by consumers, the product would reduce risk. Smokers might use the product very differently if they believe it is a reduced risk product than if they don't.

In other words, the legislation does not merely make it difficult to market a reduced risk product. It makes it literally impossible.

2. The bill contains a special rule that would allow FDA to approve certain modified risk products that cannot meet the criteria listed under (A) and (B) above. Such products must only claim to be reducing exposure to, or reducing levels of or being free of a particular constituent. Specifically, such products can be approved if "scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1)." In such cases, the major criterion that must be met is as follows: "the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies."

Thus, Section 901(g)(2)(A) essentially allows products that do not claim to reduce risk but merely claim to reduce exposure to or levels of a particular constituent to be approved by simply showing that a reduction in risk is anticipated in subsequent studies. This is a very weak standard. As long as there is any promising preliminary evidence, one could argue that reduced risk is expected if it were to be studied (this is a far cry from demonstrating reduced risk, especially given the many uncertainties including the actual use of the product by consumers and unintended side effects or consequences).

The effect of 901(g)(2)(A), then, is essentially to allow the approval of reduced exposure products and to allow these products to be marketed as such, even though there is shoddy scientific evidence of any health benefit. This institutionalizes the very problem (unsubstantiated health claims) that health groups supporting this legislation have expressed so much concern about. The fact that the bill does not allow these products to represent themselves as reducing health risk is largely irrelevant, because consumers are going to perceive them as reducing risk. How else would someone interpret a claim of reduced exposure?

Of note, the bill does require that there be testing of consumer perception which shows that as the product is proposed to be labeled and advertised, it will not mislead consumers into thinking that the product reduces health risk. However, there are no restrictions on who must do the consumer testing and what the conditions or protocols must be. It would be relatively easy for a company to do consumer testing in such a way that they obtain the result they want to show. Anyone familiar with survey research, focus group studies, or other types of formative research knows that the way questions are asked and the specific protocols used can shape consumer responses substantially. Similarly, post-market surveillance protocols are left to the companies.

The proposed FDA legislation is thus the worst of both worlds. On the one hand, it allows companies to gain a government sanction to market products under the guise of reduced risk by merely calling their product reduced exposure. On the other hand, it prevents companies from marketing products that may truly be reduced risk products by putting an impossible regulatory burden in the path of such products.

Despite all the rhetoric, the proposed FDA legislation would do nothing to save lives, but would instead ensure that the highest risk products remain firmly entrenched in the marketplace, without any competition from what could be life-saving alternatives. Of course, this lack of effective competition is why Philip Morris adores this legislation.

What it comes down to is protecting the profits of the nation's largest tobacco company at the expense of the public's health. That Philip Morris is lobbying for this legislation makes perfect sense, and it is the company's fiduciary responsibility to do nothing less. That the Campaign for Tobacco-Free Kids and other major anti-smoking groups are joining alongside Philip Morris in promoting this legislation is nothing less than a travesty.

3. The Legislation Makes a Public Health Blunder – Asking the FDA to Prevent the Addiction of Kids by Lowering Nicotine Levels, But Preventing the Agency from Eliminating the Nicotine

Due to a Mechanism Known as Compensation, Reducing Nicotine Levels Would be a Public Health Disaster; Smokers Would Smoke More, Increasing Tar Delivery and Deaths from Cancer and Chronic Lung Disease

According to a recent report released by the Harvard School of Public Health,1 cigarette companies steadily increased the nicotine yield of their cigarettes during the period 1997-2005. The report describes the increase as being a total of 11% over the seven-year period 1998-2005, or an average increase of 1.6% each year during that period.

Major anti-smoking groups also hailed the study and told the public that it shows the need for FDA regulation of tobacco products. The Campaign for Tobacco-Free Kids used the study results to call for passage of legislation that would grant the Food and Drug Administration (FDA) authority to regulate tobacco products2:

"A new study released today by the Harvard School of Public Health shows the critical need for Congress to enact legislation granting the U.S. Food and Drug Administration (FDA) authority over tobacco products. The Harvard study expands on and confirms an August 2006 study released by the Massachusetts Department of Public Health that found that tobacco companies have deliberately increased the levels of nicotine in cigarette smoke since 1998. The FDA legislation would require tobacco companies to disclose to the FDA changes in their products and provide FDA the authority to require them to reduce levels of constituents, like nicotine that make them more harmful or more addictive. ... The fact that the tobacco companies have been able to secretly increase nicotine levels in tobacco smoke occurred only because no federal or state agency currently has regulatory authority over cigarettes or what tobacco companies put in cigarettes. ... The proposed legislation would grant the FDA the authority and resources to stop harmful tobacco company practices that continue to addict children... ."

The steady and significant increase in nicotine yields cigarettes over the past eight years or so sounds like a concerning finding. It sounds like cigarette companies are increasing the addictive potential of their cigarettes and harming the public's health in a way that demands passage of the proposed FDA tobacco legislation. At least this is what the major anti-smoking groups want the public to think.

There are, however, two major problems with this.

First, an increase in nicotine yields does not necessarily mean that the public's health has been harmed. It is well documented that smokers compensate in response to changes in nicotine yields to maintain exposure to a relatively constant nicotine dose. This is why "light" cigarettes are not safer products. While the nicotine levels are lower, smokers compensate by simply smoking more; this negates the potential benefits of reduced nicotine and tar levels.

In a similar way, smokers might be expected to compensate by smoking slightly less if nicotine yields increase. This could actually have a marginally positive health benefit if it reduces overall cigarette consumption.

In fact, the report1 acknowledges this important point:

"The increase in smoke nicotine yield does not necessarily signify any change in exposure within the population of smokers, particularly as human smoking behavior is compensatory and will adjust for differences in smoke yield."

If anything, the proposed legislation would actually harm efforts to protect the public's health. By focusing on increases in nicotine yields as if they are necessarily harmful to public health, the legislation implies that decreases in nicotine yields would be a good thing. But the truth is that reduced nicotine yields could be harmful to public health because they would likely increase cigarette consumption (due to compensation), leading to increased tar delivery and higher rates of lung and other cancers as well as chronic lung disease.

If lawmakers are disturbed by the addictiveness of cigarettes, then there's only one thing that can be done - and that's to require the elimination of the nicotine. Short of that, there's nothing that can be done. At least not anything beneficial. Requiring reductions in nicotine levels would be the worst thing we could do, because cigarette consumption would rise due to compensation, causing increased tar delivery and increased disease and death.

Regulating the levels of nicotine to make sure that they don't increase would be absolutely useless. Forcing the levels to come down would be absolutely disastrous for the public's health. There is no point in using the addictiveness of cigarettes to argue for the need for FDA regulation unless what you are calling for is granting the FDA the power to eventually eliminate the nicotine from cigarettes.

If the Campaign for Tobacco-Free Kids and other anti-smoking and public health groups were truly sincere in their public statements that we need to do something to protect kids from cigarette company attempts to addict them through the manipulation of nicotine in cigarettes, then the only viable option is to remove the nicotine. Nothing else would work - and in fact, merely lowering the levels of nicotine would actually harm the public's health.

Let’s face it. This legislation represents a purely political compromise to protect the financial interests of the tobacco companies. Maybe that is the right thing to do, but let’s cut out the rhetoric and simply admit that this is all about politics and not about protecting our children from the addictive nicotine in cigarettes.

On January 17, Senator Edward Kennedy released a statement3 in response to the Harvard University School of Public Health report which concluded that nicotine yields of cigarettes have increased steadily over the past eight years. In the statement, Senator Kennedy condemned Big Tobacco for addicting millions of young smokers due to these rising nicotine levels and called it a travesty for Congress to be an accomplice to this addiction by failing to enact legislation that would allow the Food and Drug Administration (FDA) to prevent this from happening.

Senator Kennedy said3:

“This study is an extraordinary public service by Harvard’s School of Public Health. It’s dramatic new proof that Big Tobacco is addicted to addicting millions of young smokers into lifetimes of illness and early death. Congress has been an accomplice in the travesty because of the success of the tobacco lobby in blocking real reform. Hopefully, the study will be a wake-up call to persuade Republicans and Democrats alike to enact long overdue legislation allowing the FDA to regulate cigarettes and deal with their enormous risks.”

Unfortunately, Senator Kennedy's statement deceives the American public into believing that the legislation which Senator Kennedy has introduced would actually do something to protect our nation's youths from the addictive nature of nicotine in cigarettes.

It turns out that the legislation that is proposed would not do anything to address the problem of the nicotine addiction of our nation's children.

In contrast, the proposed legislation would actually institutionalize the addiction of our nation's children into law, ensuring that the Food and Drug Administration could never address the problem of nicotine addiction of our children by requiring the elimination of nicotine from cigarettes. The legislation would ensure that cigarettes always contain nicotine, and thus always maintain the potential to addict our children, regardless of whether we ever reach a point where social norms change in a way that would otherwise make feasible the FDA's gradual phasing out of nicotine from cigarettes.

Ironically, if you want to give the FDA the power to possibly reduce the harms of cigarettes, the one thing that might actually work would be to mandate very high levels of nicotine in cigarettes.

This would have two beneficial effects: first, it would substantially reduce the intensity of smoking and levels of consumption, reducing tar delivery and lowering cancer and chronic lung disease risks.

Second, it would make cigarettes all but "unpalatable" for kids, ensuring that fewer young people would take up the habit and have it turn into an addiction. But established smokers would still be able to obtain their nicotine.

This proposed legislation would not allow the FDA to mandate increases in nicotine levels in cigarettes. According to section 907(a)(4)(a)(i) of the legislation, the FDA could only require reductions of certain constituents in cigarettes.

4. The Legislation Would Preclude the Single Most Effective Regulatory Action to Protect Health that is Politically and Technologically Feasible

By Precluding the FDA from Requiring an Increase in the Nicotine Yields of Cigarettes, the Bill Eliminates a Regulatory Option Recommended by the Institute of Medicine that Could Produce a Safer Cigarette

It honestly seems disingenuous to me to condemn the cigarette companies for addicting our nation's youths with the nicotine in their cigarettes and then to support legislation that would institutionalize the addiction of our nation's youths by precluding the FDA from removing the nicotine. It seems disingenuous to me to suggest to the public that we need FDA legislation to address the problem of the nicotine in cigarettes, but then support legislation that precludes FDA from doing anything other than reducing the nicotine levels.

The reason? Reducing nicotine levels will not make cigarettes non-addictive. Reducing nicotine levels will not stop kids from smoking. Reducing nicotine levels will not end the problem of the addiction of our nation's youths.

What will reducing nicotine levels do? It will create a public health disaster by deceiving the public into thinking cigarettes are safer. It will lead to compensation by smokers, who will smoke more to maintain their dosage of nicotine. These smokers will therefore be exposed to higher levels of tar, which will lead to more cancer and emphysema. In short, reducing nicotine levels, without eliminating the nicotine, will kill people.

I think it is most reasonable to argue that removing the nicotine from cigarettes is not a feasible solution to the problem of addiction. I would never criticize someone for suggesting that the FDA should not be given the authority to require the elimination of nicotine from cigarettes. However, I find it inappropriate to mislead people by suggesting that the increased nicotine yields in cigarettes demands enactment of the FDA legislation that has been introduced in Congress. If the fact that cigarette companies are using nicotine to addict youths is a travesty and it needs to be stopped, then the only way to do that is to get rid of the nicotine. You can't bemoan the presence of nicotine in cigarettes, suggest that we need legislation to take care of the problem, and then deceive the American people by supporting legislation whose fine print actually precludes the FDA from taking care of the problem.

I can't over-emphasize this fact: reducing the nicotine yields of cigarettes will not take care of the problem.

What is so disturbing about this story is that we, as tobacco control advocates, have condemned the tobacco industry for doing precisely this: reducing the nicotine yields of their cigarettes.

In fact, we have taken the tobacco companies to court and helped to convict them of racketeering and fraud by virtue of the fact that they chose to decrease the nicotine yields of their cigarettes and market the cigarettes as having lower nicotine yields and therefore being "lighter." We have argued, apparently successfully, that marketing low-nicotine-yield cigarettes is fraudulent, because it deceives the American people into thinking that the product is somehow safer when the truth is that it is not any safer.

So why in the world would we propose a regulatory scheme in which we will do to the public exactly what the tobacco companies have done and been convicted of a crime for doing?

Tobacco control groups and advocates who are supporting this FDA legislation are essentially calling on the government to do exactly what the tobacco companies tried to do, but for which they were accused and convicted of racketeering and fraud: to reduce nicotine yields of cigarettes.

Such an action by the FDA would certainly mislead smokers into thinking that the product is safer. The truth, however, is that the product would not be any safer. And it might actually be more dangerous.

The truth is that, short of removing the nicotine, the only effective regulatory action that could actually protect the public's health would be to require increases in the nicotine yields of cigarettes. Greatly increasing the nicotine/tar ratio of cigarettes would allow smokers to obtain the same amount of nicotine dosage while inhaling substantially lower amounts of tar. This could potentially reduce cancer and chronic lung disease rates.

However, the proposed legislation precludes the FDA not only from eliminating the nicotine, but also from requiring such increases in nicotine.

According to section 907(a)(4)(A)(i) of the proposed legislation: "A tobacco product standard established under this section for a tobacco product— (A) shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate— (i) for the reduction of nicotine yields of the product."

So the FDA cannot do the one thing that might actually produce some health benefits from regulation of the nicotine content of cigarettes.

5. The Legislation Would Essentially Transfer the Misrepresentation of the Safety of Cigarettes from the Tobacco Companies to the Government

By Establishing Product Safety Standards for Which There is Not Adequate Evidence of a Health Benefit, the Government Would Be Making Precisely the Same Type of Fraudulent Health Claims for Which Judge Kessler Found the Tobacco Companies Guilty

In her final opinion in the Department of Justice tobacco lawsuit against the tobacco companies, Judge Gladys Kessler ruled that the defendants had engaged in fraud by marketing cigarettes that rated lower yields via machine testing in a way that falsely led consumers to believe that these products offered a health benefit over higher machine-yield products.

A major part of the basis for this decision was a body of literature demonstrating that machine-yields of nicotine and other tobacco constituents have no direct relationship with actual human exposure, and thus with actual health risk, either on an individual or a population level. Machine yields, for example, do not adequately account for changes in human smoking behavior (e.g., compensation) which accompany any change in the yields of cigarettes.

A report published recently in the journal Tobacco Control and written by a group of tobacco control experts confirmed not only that machine-measured toxin yield information is virtually meaningless, but that newer advances in the way in which these yields are measured - which attempt to more closely simulate actual smoking behavior - are inadequate, and even these new methods do not yield information that is of any consumer value.4

"Although each of the testing regimes will help to "characterise" how a product performs under a given set of smoking conditions, none of the smoking regimes "represent" human behaviour in terms of compensatory smoking and none is likely to produce emissions that will be markedly associated with human exposure or risk, either for individual smokers or for population-level differences between brands." ...

"After nearly 40 years—and after great cost to public health—the public health community is now coming around to the realisation that lower ISO emission cigarettes are not lower-risk products. Unfortunately, many regulators fail to understand the distinction between "product characterisation" and predicting human exposure. At the same time as they insist that cigarette emissions are not measures of risk, various regulators continue to use cigarette emissions in ways that assume a link between the machine emissions and human exposure. Many jurisdictions continue to require that quantitative levels of tar, nicotine and carbon monoxide appear on packages. These numbers continue to be misunderstood and misused by smokers, including smokers in the most affluent and highly educated countries in the world. To date, there is no evidence that quantitative emissions constitute effective consumer information, and several scientific bodies have rightly called for the removal of these emissions from packages. ... the tobacco industry should be prohibited from using machine emissions in any of its labelling, advertising or marketing directed at consumers, even if accompanied by "warnings" or disclaimers, such as those that currently appear in the US and Europe." ...

"patterns of use must be examined to understand the interaction between product design and smoking behaviour in humans, and to identify systematic differences across products. Products that deliver fewer toxins for a fixed volume of smoke and also promote greater smoke intake when used by consumers are not lower-risk products. Likewise, products that deliver higher amounts of toxins, but discourage repeated use might potentially be seen as harm reducing compared with conventional cigarettes."

This is the flawed logic that underlies the proposed FDA legislation: We know that measurements of the amounts of various constituents in cigarettes have no demonstrable relationship with actual human exposure or with actual human health risk, so we propose a system to regulate the safety of cigarettes that relies upon reducing the measured levels of various smoke constituents. What an absurd idea.

We attack the tobacco companies for relying upon cigarette constituent measurements in making implied health claims, take them to court, get them convicted for fraud, and then proceed to go ahead and propose to set our own cigarette constituent level regulations, thereby making our own unsubstantiated implied health claims.

Unfortunately, the idea isn't just absurd. It's also damaging. The reason? Because like the machine-measured nicotine yields that we blasted the tobacco companies for relying upon in their communications, these FDA-sanctioned tobacco constituent levels will have no demonstrable relationship to the public's health, yet they will most certainly be interpreted by consumers as conveying an improved degree of safety.

There is no question that by virtue of cigarettes being placed under the regulatory jurisdiction of the FDA and by virtue of FDA promulgating "product safety standards," the public is going to assume that cigarettes have been made to be a safer product. However, those product safety standards are none other than specified reductions in a number of specifically chosen tobacco constituents, whose levels have not been shown to correlate directly with human health risk.

Essentially, what the proposed FDA legislation would do is simply change who is committing the fraud. Right now, it's the cigarette companies doing the dirty work, marketing reduced tar and reduced nicotine cigarettes in a way that deceives consumers into believing that these products are known to be safer. If the FDA legislation is enacted, then it will the government who is doing the dirty work, implying to the public that reduced X and Y cigarettes are known to be safer, when there is absolutely no evidence that such a product would, in fact, be safer.

No wonder why Philip Morris loves this legislation so much. It completely takes away the risk of litigation for fraud, yet allows the tobacco companies to tell consumers that they are complying with stringent product safety standards, assuring a safer product that is produced under the strict scrutiny of the Food and Drug Administration.

This whole thing has the potential to institutionalize the fraud that the tobacco companies have committed, but to put it into the hands of our own government.

The Tobacco Control review article4 points out many reasons why regulation of tobacco smoke constituent levels would not necessarily produce a safer product:

"not all constituents change to the same extent or even in the same direction under different testing regimes—for example, the NNK and benzo[a]pyrene:nicotine ratios decrease under more intense puffing conditions, whereas the nicotine ratio for carbon monoxide increases, as does the overall tar:nicotine ratio. It is unclear to what extent certain emissions can be reduced independently of others. Manufacturers have also shown their skill in substantially reducing machine emission levels through subtle design changes. Recent evidence from the UK suggests that tobacco manufacturers have adhered to the "10–1–10" limits on ISO emissions simply by increasing the level of filter ventilation so that brands provide deceptively low readings under machine conditions. Filter ventilation is the most prominent, but by no means the only design change available to manipulate yields. ... Emission limits will require considerable resources to implement and monitor, resources that may exceed the current capacity of regulators. There are also concerns that emission limits would exempt tobacco manufacturers from liability. Most important, it is uncertain how consumers will respond to emission regulation. Despite clear scientific statements to the contrary, consumers may interpret emission limits as an indication that cigarettes are less harmful—much in the same way that they have interpreted emission reductions in the past. In fact, future emission limits may be even more likely to undermine perceptions of risk than in the past: "new" emission reductions would be based on a "superior" machine method, would be more comprehensive in scope, and may have the formal endorsement of the [FDA]. ... one can also envision how manufacturers might shape consumer response through packaging and marketing. Overall, regulations that achieve modest reductions in smoke toxicity but result in fewer quitters or more initiators are not effective policy measures."

But the most important reason why the product safety standard approach taken in the proposed FDA legislation is a potential disaster is that there is simply no evidence that cigarettes can be made to be a safer product, in actual human practice, simply by mandating a reduction in levels of specified smoke constituents.

We simply do not know which constituents, at what levels, and in what combination, result in what degree of risk of what diseases that are caused by smoking.

Anyone who promises you that they are going to "save countless lives" via these product safety standards (precisely what the Campaign for Tobacco-Free Kids is telling its constituents) would probably also be effective in selling you a bridge in Brooklyn.

In one respect, the Campaign for Tobacco-Free Kids is precisely correct in stating that this legislation is going to save countless lives. It is so unclear that product safety standards will do anything to reduce overall health risks that it is impossible to count any lives that will be saved. Perhaps that's why the Campaign is having trouble counting them.

Ultimately, there's only one way that I think even has the potential to be successful in developing safer cigarettes or other tobacco products. And that's to allow the free market system to work. Free market competition could, possibly, result in a race to see which company could come up with safer products. The proposed FDA legislation, however, destroys the possibility of this free market competition by making it impossible for any tobacco company to market a truly reduced risk product.

What the bill does, on the other hand, is set up a competition to see who can market a reduced exposure product, which, just like reduced-nicotine or reduced-tar cigarettes, is likely to be just as effective in killing people, but which would most certainly be interpreted by the public as implying a reduced health risk.

Essentially, what the proposed legislation does is set up a system of government-administered public fraud in order to benefit the tobacco companies.

6. Rather Than Set Up a Meaningful Scheme for Regulation of Tobacco Products, the Legislation Merely Provides Window Dressing

The legislation that some health groups have been claiming creates an effective public health policy actually does the following:

  • It bans the presence of strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee in cigarettes, but does not inherently disallow the presence of hydrogen cyanide, carbon monoxide, N-nitrosodimethylamine, benzene, radioactive polonium 210, or nitrogen dioxide.
  • It requires FDA to ban any tobacco product that contains a severely harmful chemical defect, but explicitly prevents FDA from doing the same with tobacco products that contain thousands of severely harmful chemicals, so long as those chemicals are ordinarily contained in tobacco products.
  • It provides for stringent regulation to prevent adulterated or misbranded products, but leaves the "pure" and "properly branded" deadly products largely unregulated.
  • It requires that manufacturers report any adverse health effects of its products that are unexpected, but the expected 450,000 or so deaths per year due to these products require no special attention.
  • It expresses grave concern for the tremendous harm to the public health caused by tobacco products that falsely purport to reduce disease risk, but does not seem to find the harm caused by the high-dose products to be of much alarm.
  • It strictly regulates new tobacco products introduced to the market for safety and health, but allows existing products to continue killing hundreds of thousands of Americans each year.
  • It expresses grave concern over youth access to tobacco products and calls for comprehensive restrictions on the sale of tobacco products to minors, but it explicitly prevents FDA from regulating the sale of cigarettes in any specific retail establishments (including malls, grocery stores, restaurants, gas stations, convenience stores, bowling alleys, and even pharmacies).
  • It provides for extremely rigorous and comprehensive (and probably impossible) tobacco company reporting of brand-specific levels of tobacco smoke constituents, but does not require any particular action concerning the more than 4000 constituents that are already known to be harmful.
  • It requires the FDA to establish a series of health standards regarding the nicotine and harmful constituents of tobacco smoke (and no health standard other than finding the cigarette itself to be inherently and unacceptably toxic is rational or defensible), but then prevents FDA from requiring even the gradual elimination of nicotine from cigarettes, or from requiring the gradual shift to a system of prescription-only cigarette access, or from ever requiring even a gradual elimination of cigarette products from the market.
  • It requires the FDA to prescribe labeling requirements for the proper use of the tobacco product. How does one properly inhale thousands of dangerous chemicals and scores of deadly carcinogens?
  • It requires FDA to consider periodically new medical data on cigarette risks, but the existing evidence on the established risks of cigarettes can be largely ignored.
  • It requires notification to all tobacco product users of the substantial health risks of any new tobacco products, but no special notification procedures for the existing deadly products.
  • It requires FDA to recall and ban any tobacco product that contains a manufacturing defect that is not ordinarily present in tobacco products, but a serious defect - such as producing death in one out of every two long-term users - is fine, so long as the deaths are caused by an ordinary constituent of the product rather than a new manufacturing defect.
  • It allows the FDA to prescribe strict regulations to protect the public's health from sub-standard packing and storage, but the fact that what is being packed and stored is inherently dangerous is of little concern. The FDA may prescribe stringent regulations to eliminate any pesticide residues on the tobacco, but the rest of the toxins inside the tobacco are not necessarily regulated.

The fatal flaw of the legislation is the unacceptable degree of restriction of FDA's potential actions which makes it impossible for FDA to act appropriately within the legislative mandate it is given.

Although this legislation eliminates the chocolate in cigarettes and prevents cigarette companies from misrepresenting their new products as being safe, the latter has been happening for more than half a decade, and the dangers of existing "normal risk" products are far more important than anything else. We should be focusing our efforts on addressing the nation's current tobacco-use epidemic, which is killing more than 400,000 Americans each year.

7. The Proposed Legislation Will Be Detrimental to the Public’s Health

By Giving Tobacco Products an FDA Stamp of Approval, the Legislation Will Undermine the Public’s Appreciation of the Dangers of Cigarettes, but Without Actually Ensuring that These Products are Significantly Safer

This legislation is severely detrimental to the best interests of the public's health. While the health groups supporting the bill are arguing that although it's not perfect, it's better than the status quo, a careful analysis reveals that it is not better than the status quo, but instead, would represent a substantial loss for public health.

The three major reasons why this is the case are:

1) The overall regulatory framework of the bill is counter-intuitive to basic public health principles. The bill would protect existing cigarette products by making it nearly impossible for potentially reduced risk products to enter the market. At the same time, it would allow tobacco companies to market products as having reduced levels of certain toxins without having to provide any substantial evidence of a health benefit. Thus, the basic regulatory framework established by the bill as relates to reduced risk products would do two disastrous things. First, it would make it virtually impossible for reduced risk products to enter the market. It would take away any economic incentive for companies to do meaningful research and development of potentially significantly safer products. Second, it would actually institutionalize the problem of misleading health claims regarding reduced exposure products - the very problem that the health organizations keep emphasizing is so unacceptable. But the bill itself creates a regulatory framework by which companies can market their products as being reduced exposure products without any solid scientific substantiation of a health benefit. The public does not consist of scientists. The public is going to interpret a reduced exposure claim as being a reduced risk claim. Thus, the problem of unsubstantiated (implied) health claims about tobacco products will not only remain, it will now be sanctioned and operated through FDA.

2) The bill would essentially put an end to the prospect of any meaningful punishment of the industry, receipt of punitive damages for victims of classes of victims of tobacco-caused death, disease, and personal suffering, or achievement of real industry changes through litigation. In previous litigation, the tobacco companies have successfully used the argument that they are already regulated so there is no need for further steps to deter future bad behavior. They gained tremendous mileage from the tobacco settlement in this regard. But they would gain even greater mileage from FDA regulation. They would then be able to claim that the federal government has assumed jurisdiction over all aspects of tobacco operations, including manufacture, new product introductions, health claims, health standards, ingredients, additives, and smoke constituents, nicotine, advertising, access, and marketing (which would be true), and that there is therefore no need for any further injunctive relief or punitive damages to deter future bad activity - it is all under FDA's control now. And from a public perception standpoint they would be right.

It is important to understand that the important point is not whether the legislation actually gives the companies any immunity or protection from litigation. The important point is simply whether or not the companies can use the fact of being regulated by FDA to achieve de facto immunity by taking advantage of the public perception that the problem is basically taken care of.

3) This legislation is likely to result in increased, not decreased deaths from tobacco products, for the following reasons:

a - It will make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products. It essentially freezes the market as it is and entrenches existing high-risk products into the market. It puts an end to any meaningful possibility of harm reduction as a tobacco control approach.

b - It will undermine current and future litigation: the companies will be able to successfully use the argument that they are already regulated to stave off injunctive relief and substantial punitive damages in litigation by appealing to jurors' perceptions that the problem is "taken care of." The highly exaggerated claims of the positive public health impacts of this legislation that the health organizations are making are only contributing to this perception.

c - It will reduce the public's perception of the inherent harms of cigarettes. By promulgating health standards, FDA will be giving the public the perception that cigarettes are now safer to smoke. The public is not necessarily aware of the 4,000 toxins and 50+ carcinogens in the smoke, nor are they epidemiologists - if they are told that the nitrosamines have been removed, they are naturally going to perceive that the problem is being taken care of, or at least largely taken care of. Since we know that smoking prevalence is directly proportional to the degree of perceived harm from smoking, this will lead to an increase in smoking prevalence (at least compared to what would have occurred in the absence of the legislation).

d - Most importantly, there are no documented mechanisms by which the legislation will save lives. Health groups supporting this legislation have not produced a single solid, evidence-based argument of how this bill will save lives.

There are really only three ways in which this could occur:

First, the bill could save lives if the performance standards reduced the relative risk of smoking-related diseases. There is absolutely no evidence that this is the case - we simply do not know the specific constituents that are responsible for the diseases as well as the relative contribution of each, alone and in combination, nor do we have any evidence for there being a decreased relative risk associated with product changes that eliminate or reduce a single or a few components.

Second, the bill could save lives if it encouraged the research, development and marketing of actual reduced risk products. But in fact, the bill does the opposite. It puts an almost impossible barrier in front of the development and marketing of these potential products. It also puts a virtually insurmountable barrier over other potential harm reduction efforts - such as promoting the use of snus or other less hazardous nicotine-delivery devices.

Third, the bill could save lives if it reduced youth smoking. It has been well documented that youth access restrictions, implemented in actual widespread practice, do nothing to reduce youth smoking. So the access regulations are essentially meaningless. And the three access restrictions that could potentially reduce youth smoking have been precluded (raising the legal age of purchase, restricting the types of establishments that sell tobacco, and phasing in some sort of prescription-access system).

Research has also documented that the kinds of marketing restrictions imposed by the bill are not effective in reducing youth smoking, or even in reducing youth exposure to cigarette advertising. There are simply too many avenues for the tobacco companies to market their products, and anything short of a near total ban on advertising and promotion of tobacco products (which clearly would violate the First Amendment based on the Supreme Court's interpretation) is unlikely to have a substantial effect on youth smoking. A number of articles document that even major changes in policy, such as removing ads completely from youth-oriented publications, does not reduce youth exposure to this advertising to any meaningful (from a public health perspective) degree.

In fact, Central Hudson provides a perhaps insurmountable obstacle to the advertising restriction approach to tobacco control, because of two basically conflicting prongs. First, the restrictions would need to be comprehensive enough so that they have a substantial impact on smoking behavior. Second, the restrictions would have to be crafted as narrowly as is possible to address the relevant government interest. It remains to be seen whether this can be done and if it can result in regulations that have a substantial public health effect. We simply don't have evidence yet that it can be done, and there is no justification for highly touting this bill as being the ultimate answer to curtailing cigarette advertising.

Finally, the bill could save lives if it reduced adult smoking (or youth smoking) by reducing cigarette demand. It won't do that by increasing the competition in the marketplace and it won't do that by increasing the public's perceptions of the inherent risks of smoking.

In summary, there simply is no documented evidence to suggest that (or how) the proposed legislation will save lives. In contrast, there is well-documented evidence (including substantial literature in the fields of tobacco product chemistry, tobacco epidemiology, psychology and public opinion research, framing theory, and mass communications [including marketing and advertising] research) to suggest that the legislation is unlikely to provide any public health benefits in terms of reducing the relative risk of smoking or increasing the use of lower-risk tobacco products, but that it is likely to produce public health harm through its institutionalization of high-risk products, its barriers to the introduction of reduced risk products, its probable effects on litigation, its probable effects on public opinion and attitudes towards tobacco products and towards the tobacco industry, and its probable effects on slowing down the pace of other tobacco control legislative efforts (including what will be a chilling effect on state and local tobacco control legislation).


  1. Connolly GN, Alpert HR, Wayne GF, Koh H. Trends in Smoke Nicotine Yield and Relationship to Design Characteristics Among Popular U.S. Cigarette Brands. Boston, MA: Tobacco Research Program, Division of Public Health Practice, Harvard School of Public Health, January, 2007. (link)
  1. Campaign for Tobacco-Free Kids. Harvard Study Confirms Tobacco Companies Increased Nicotine Levels In Cigarettes, Highlights Need For FDA Regulation of Tobacco. Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids (press release). Washington, DC: January 18, 2007. (link)
  1. Office of Senator Edward M. Kennedy. Statement By Senator Edward M. Kennedy On Harvard Study Revealing Big Tobacco Efforts To Keep Smokers Hooked (press release). Washington, DC: Office of Senator Edward M. Kennedy, January 17, 2007. (link)
  1. Hammond D, Wiebel F, Kozlowski LT, Borland R, Cummings KM, O’Connor RJ, McNeill A, Connolly GN, Arnott D, Fong GT. Revising the machine smoking regime for cigarette emissions: implications for tobacco control policy. Tobacco Control 2007; 16:8-14.

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