News: Senator Kennedy and the FDA Page 1

By Jonathan On Jul 5, 2017

When it turns out their purported solution would actually institutionalize the very problem at hand, I think it’s time to do more than simply ask questions.

Newest Articles At: Senator Kennedy and the FDA Page 2

All for Philip Morris
Politicians stand up to Big Tobacco by protecting the leading cigarette maker.

Jacob Sullum
February 21, 2007

“The days of Congress doing the bidding of the tobacco industry are over,” Rep. Henry Waxman (D-Calif.) declared last week. “This long overdue legislation would give FDA broad powers to regulate tobacco products and protect Philip Morris.”

Actually, Waxman said “protect public health,” but I’ve taken the liberty of decoding the phrase for you. The bill to which Waxman was referring, the Family Smoking Prevention and Tobacco Control Act, has the enthusiastic backing of Philip Morris, which thinks regulation by the Food and Drug Administration will help shore up its position as the leading cigarette manufacturer. Take that, Big Tobacco!

Waxman’s bill, which has bipartisan support and a good chance of passing now that the Democrats control Congress, shows that politicians are happy to help big corporations hobble their competitors, as long as they can claim to be acting in the interests of consumers. This trick is especially easy in the case of tobacco, since its consumers are considered irrational by definition and therefore do not get to judge their own interests.

Waxman’s bill would codify the advertising and promotion regulations issued by the FDA in 1996, when the agency was pretending it already had the authority Waxman wants to give it. (The Supreme Court disagreed.) Among other things, tobacco ads in publications read by minors would be limited to black text on a white background, as would tobacco signs in stores open to minors.

By impeding brand competition, advertising restrictions help keep market shares the way they are, which is fine—if you’re Philip Morris. As an R.J. Reynolds spokesman put it, “If you eliminate ways to communicate with…consumers, that certainly benefits the market leader and makes it difficult, if not impossible, for those who aren’t the market leader to compete.”

As the biggest cigarette maker and the one that has been pushing and preparing for FDA regulation, Philip Morris is also best positioned to comply with the federal government’s reporting requirements, manufacturing standards, and approval process for new products. Those demands will weigh more heavily on smaller companies, especially upstart competitors.

Even the more obscure provisions of Waxman’s bill seem tailor-made for Philip Morris. For example, the bill permits menthol cigarettes, which Philip Morris sells, but prohibits various flavorings used by R.J. Reynolds.

The promise of improving “public health” by limiting competition should sound familiar. It was the rationale for the agreement that resolved state lawsuits against the major tobacco companies by creating a government-backed cigarette cartel designed to funnel money into state treasuries.

Under that deal, the top five cigarette companies—including the ones that are now complaining about Philip Morris’ efforts to protect its market share through FDA regulation—agreed to give up some marketing techniques (including billboards and promotional clothing) and to pay the states billions of dollars every year. They funded the payments by raising their prices, secure in the knowledge that the states would prevent nonparticipating companies from gaining market share by underselling them.

Higher prices due to reduced competition were counted as a benefit of the agreement, encouraging smokers to quit and deterring teenagers from picking up the habit. The fact that smokers themselves might prefer cheaper cigarettes did not matter to the attorneys general who negotiated the deal.

Likewise, Waxman’s bill pays no heed to smokers’ preferences regarding cigarette flavors, prices (which the regulatory burden and limits on competition would tend to drive up), nicotine levels (which the FDA would be empowered to reduce), safer cigarettes (which the FDA could keep off the market if it thought they would encourage people to continue smoking), or information on the relative hazards of different tobacco products (which the FDA would be authorized to censor). While he seems determined to make Philip Morris happy, Waxman does not seem to care what consumers want. Or rather, he cares, but he wants to make sure they don’t get it.

Long legal precedent is against FDA regulation of cigarette sales
Any restraints have traditionally been in Congress’ hands

By Richard Craver, JOURNAL REPORTER
February 16, 2007

The U.S. surgeon general first warned consumers about the risks of smoking cigarettes nearly 43 years ago.

Despite many health studies connecting tobacco with cancer and other diseases, and increasing opposition to smoking in public places, the industry remains free from federal regulation and subject only to congressional restrictions.

As the latest bill aimed at putting tobacco products under Food and Drug Administration oversight was introduced in Congress yesterday, some health-advocacy groups believe that the political climate is ripe for regulatory control this year.

FDA regulations would further restrict tobacco marketing as the industry already struggles with a declining smoking rate. Adding graphic health warnings similar to those in other countries could make selling tobacco products even tougher, while banning the sale of candy- and fruit-flavored cigarettes could hamper the industry’s ability to attract young adult consumers.

Reynolds American Inc. has long opposed federal regulation of tobacco products because of concern that it would further restrict its ability to market to adults.

Federal regulation also could affect the 27,460 North Carolinians whose jobs depend on the tobacco industry, including 11,900 in manufacturing, according to the U.S. Bureau of Labor Statistics. Reynolds American, based in Winston-Salem, and its subsidiaries have 4,200 employees in the state.

Yet, analysts said that proponents of federal regulations face an uphill battle even in a Democratic-led Congress.

That’s because:

• Congress has preferred to place restrictions on the tobacco industry, starting in 1965, over allowing a federal agency to have oversight.

The last significant push for FDA oversight came in 2004 when it was attached to a bill on the $10.1 billion tobacco-quota buyout. The provision was removed to ensure votes from tobacco-state senators.

A similar removal of legislation occurred in 1998 before 46 states and the major tobacco companies agreed to the $206 billion Master Settlement Agreement.

• Congress created the FDA to ensure that products are safe and effective in their intended use. A product documented as unsafe, such as cigarettes, would not be allowed, according to FDA rules.

“Congress, however, has foreclosed a ban on such products, choosing instead to create a distinct regulatory scheme focusing on the labeling and advertising of cigarettes and smokeless tobacco,” according to the majority opinion of a 5-4 vote by the U.S. Supreme Court in March 2000.

In its failed bid to assert jurisdiction over tobacco, the FDA said it could regulate the marketing and sale of tobacco products because it considered nicotine as a drug and tobacco as a device for delivering the drug.

• Tobacco manufacturing still plays a crucial role in the economies of such politically pivotal states as North Carolina.

According to the U.S. Census Bureau, the tobacco industry’s estimated economic impact on the country’s gross national product is more than $64 billion. The industry’s economic impact in North Carolina is estimated at more than $7 billion.

The majority opinion from the Supreme Court stated that Congress’ reason for exempting tobacco from FDA regulation was “to protect commerce and the national economy while informing consumers about any adverse health effects. Thus, an FDA ban would plainly contradict congressional intent.”

Sen. Elizabeth Dole, R-N.C., who opposes the new proposals, said this week that other federal agencies are “much better suited to administer any new regulations on the industry.”

Health-advocacy groups said they hope that Congress will allow state and local governments to apply their own restrictions to tobacco marketing.

“We hope Congress keeps in mind the industry’s sordid history when it comes to marketing its product,” said Edward Sweda Jr., the senior attorney for the Tobacco Products Liability Project at Northeastern University’s School of Law in Boston.

The groups cite the “Frank Statement to Cigarette Smokers” ad that appeared in 448 U.S. newspapers in 1954 and was paid for by the Tobacco Industry Research Committee. Included were the statements “we believe the products we make are not injurious to health” and “there is no proof that cigarette smoking is one of the causes” of lung cancer.

In 1994 seven chief executives of U.S. tobacco companies testified before Congress that nicotine was not addictive.

The health groups also point to Reynolds’ Joe Camel ads that propelled the brand’s popularity to new heights, but eventually were banned in the 1998 Master Settlement Agreement.

“The industry may say it doesn’t target minors,” Sweda said. “But putting smoking in a favorable light in its advertising is crucial in getting the next generation to try tobacco products.”

Michael Walden, an economics professor at N.C. State University, said that Congress has to be careful not to overreach with any intent of federal regulation over tobacco products.

“Economic history shows if regulation is too severe, particularly in the availability of a product in strong demand, there’s the risk the market for the product will go underground and be controlled by illegal suppliers,” Walden said.

What’s Fraud for Big Tobacco Is Regulation for Big Government

February 14, 2007
Jacob Sullum

A new article in the journal Tobacco Control details the difficulties in using machines to predict the levels of toxins and carcinogens to which a given person will be exposed when he smokes a particular brand of cigarette. Smoking machines are used to produce the misleadingly precise tar and nicotine “yields” on cigarette packages, which may have little or no relationship to the health hazards associated with a given brand. The main problem (as I’ve mentioned before) is that people, unlike machines, engage in “compensatory behavior” to achieve the dose of nicotine to which they’re accustomed. They adjust the number of puffs and the degree of inhalation to compensate for changes in the nicotine content of the smoke. They also tend to cover the filter ventilation holes that help cigarette manufacturers achieve lower tar and nicotine ratings. The authors of the Tobacco Control article note that the standard method of generating these numbers, which uses puffing parameters that “systematically underestimate smoking behaviour in humans,” is “widely recognised to be inadequate.” They consider four alternative standards, all of which involve more-intense smoking, and conclude that they would not be significantly more reliable in predicting actual human exposure.

Two other approaches discussed in the article look more promising. One is to measure the amount of a given toxin or carcinogen per milligram of nicotine. Unfortunately, this ratio is not constant for any given brand; it varies with the intensity of smoking, which in turn varies across smokers, depending on the level of nicotine they like. Complicating things further, there are many potentially dangerous chemicals in cigarette smoke, and their levels may move in different directions when cigarette design or smoking behavior changes. Still, for some of these chemicals, there are large differences in levels per milligram of nicotine across brands that probably do translate into differences in actual exposure.

The other approach that tries to take compensatory behavior into account uses a machine protocol designed to achieve a particular dose of nicotine regardless of a cigarette’s design. Differences in toxin yields across brands measured by this method presumably would signify differences in actual exposure, at least at a given level of nicotine intake. Such measurements would be far from perfect, but they would be a more reliable guide than the current numbers. Even if a better method of predicting exposure to particular smoke constituents can be found, there remains the question of how changes in levels of specific toxins affect disease risk.

Meanwhile, the uncertainty surrounding these numbers not only casts doubt on the tobacco companies’ marketing of “low-yield” cigarettes as a supposedly safer alternative to regular cigarettes. As Michael Siegel notes on his tobacco policy blog, it also highlights the silliness of complaining about a slight increase in the machine-measured nicotine yields of major cigarette brands that may or may not have occurred in recent years. More important, it reveals the irrationality of existing and proposed government regulations. It is the federal government, after all, that requires cigarette companies to advertise the misleading yield numbers. And as Siegel points out, a bill that would give the FDA regulatory authority over tobacco, backed by Philip Morris as well as leading anti-smoking groups, would extend the use of questionable yield numbers and add to their perceived credibility. Under the bill, the FDA would have the authority to set maximum levels for specific components of tobacco smoke, based on the same sort of machine-generated numbers that public health officials and anti-smoking activists roundly condemn as not only inaccurate but fraudulent.

“This whole thing is a huge hoax in the making,” Siegel writes. “It has the potential to institutionalize the fraud that the tobacco companies have committed, but to put it into the hands of our own government.” He also argues (as I have) that the regulatory regime created by the bill would make it virtually impossible to introduce genuinely safer tobacco products. “Ultimately,” he says, “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.” To make that possible, the government would have to stop requiring misleading product comparisons, permit the introduction of new products without pharmaceutical-style regulatory review, and allow companies to make truthful statements about the potential health advantages of those products, holding them liable for fraud but not for the voluntary choices of informed consumers.

New Study Casts Doubt on Significance of Harvard Nicotine Yield Report and Wisdom of FDA Tobacco Legislation

2/13/07
By Michael Siegel
A new study published in the current issue of Tobacco Control concludes that machine-measured yields of nicotine and toxins in cigarettes are virtually meaningless, having no association with actual human exposure on either an individual or a population basis.

In the study, researchers reviewed a number of technologies used to measure nicotine and toxin emissions from cigarettes. The purpose was to assess how well these machine smoking regimes: “1) Represent human smoking behaviour, 2) Reduce the potential for industry exploitation, particularly in the area of risk communication, and 3) Serve as suitable measures for product regulation.”

In terms of the first goal, the researchers concluded that none of the machine measurement methods had any meaningful association with actual human exposure or risk of disease, either on an individual or a population level:

“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.”

In terms of the second goal, the researchers concluded that the use of machine-measured nicotine or toxin yields leaves open the door to serious distortion of smoking risks in communications to the public:

“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.”

In terms of the third goal, the researchers concluded that because of the general lack of a relationship between machine-measured emissions and actual exposure, and because of the fact that smokers will change their behavior in response to varying constituent yields, these emission measurements are not currently suitable as measures for product regulation:

“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. Measures of realistic puffing behaviour and inhalation patterns are, therefore, important for understanding different chemical and biological profiles associated with products.”

The researchers go so far as to conclude that because these machine-measured nicotine and toxin yields are so meaningless, they should be removed from all cigarette labeling and that communicating this information to the public is inherently misleading, deceptive, and likely to create an erroneous impression of the actual health risks of tobacco products, even if the statements are accompanied by disclaimers.

The Rest of the Story

If you’re paying attention, and you think about it for a minute, you will realize that what this means (if the researchers’ conclusions are valid), is that the Harvard nicotine yield report was essentially meaningless and that despite the report’s disclaimer at the end, it was inherently misleading to the public about the public health risks associated with lower or higher nicotine products.

This new review article concludes that machine measured yields – including nicotine yields – have no meaningful association with actual human exposure, either in individuals or on a population level. It concludes that nicotine yield differences between brands are also meaningless in terms of actual exposure.

Well if that’s true, then there is no significance to a report which concludes that machine-measured nicotine yields have increased slightly. It simply has no implications for drawing conclusions about either individual or population-based exposure in actuality.

The Harvard report did acknowledge this point, noting that “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.”

However, as the Tobacco Control article points out, this disclaimer alone is not enough to prevent the public from being widely misled – as has happened.

This article also makes it clear that the FDA tobacco legislation, as currently proposed, will not only fail to protect the public’s health, but will likely lead to government deception of the American consumer. The government, instead of tobacco companies, would (under the proposed legislation) control the machine-measured yields of various constituents, giving consumers the false impression that this regulation of machine-measured yields has any relationship whatsoever to human health.

In other words, what we as tobacco control practitioners have taken the tobacco companies to court over would now be something practiced by the U.S. government.

There are 2 very strange aspects to this story, which, for the life of me, I cannot figure out.

1. First, after concluding that machine-measured nicotine and toxin yields are essentially meaningless and have no relationship to actual exposure or actual health risk on an individual or population level, and after concluding that this information has no consumer value and should be taken off cigarette labeling, the authors of this paper conclude: “We strongly endorse the need to make information on cigarette emissions public to advance the evidence base for effective product regulation.”

That makes no sense whatsoever. They just got through describing in detail why this information is meaningless, and they went so far as saying that the information must be taken off labeling so as not to mislead anyone. They also just got through saying that merely by providing this information, the tobacco companies are committing fraud and deceiving consumers about the true risks of their products. So how do you get from there to a conclusion that there is a “need” to make this information available to the public?

2. Second, in the Harvard nicotine yield report itself, after noting that “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,” why do the authors nevertheless go ahead and draw their conclusions as if the increase in nicotine yields does necessarily signify a change in exposure within the population of smokers?

I seem to really be missing something here. Maybe it’s just advancing age, but the logic of the policy analysis that is going on in tobacco control right now is evading me completely.

Senator Kennedy Joins Campaign for Tobacco-Free Kids in Pulling Wool Over Eyes of American People; Integrity Impossible to Find

2/12/07
By Michael Siegel
On January 17, Senator Edward Kennedy released a statement in response to a 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 said: “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.”

A day later, the Campaign for Tobacco-Free Kids issued a press release in which they argued that the increasing nicotine levels signaled the need for legislation that would grant the FDA the authority to reduce nicotine levels in order to protect the public’s health by preventing companies from addicting children with their nicotine.

The Campaign stated: “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. … These studies demonstrate that what the tobacco industry knows and what consumers don’t, can kill us. … Legislation to allow the FDA to regulate tobacco should be given a high priority and scheduled for action early this year. The proposed legislation would grant the FDA the authority and resources to stop harmful tobacco company practices that continue to addict children, mislead consumers and devastate the nation’s health.”

The Rest of the Story

Today, I am revealing my opinion that Senator Kennedy’s and the Campaign for Tobacco-Free Kids’ statements were little other than public relations and propaganda ploys, which greatly deceive the American public into believing that the legislation which Senator Kennedy is introducing and that the Campaign for Tobacco-Free Kids is supporting would actually do something to protect our nation’s youths from the addictive nature of nicotine in cigarettes.

It turns out that the addiction of millions of our nation’s kids by nicotine in cigarettes is apparently not such a travesty, as Senator Kennedy and the Campaign would have us believe. Nor would the legislation that they are proposing do anything to address the problem of nicotine addiction of our nation’s children.

In contrast, Senator Kennedy and the Campaign are supporting legislation that 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.

According to information released by Bill Godshall, Executive Director of Smokefree Pennsylvania, Philip Morris has issued a statement confirming that the legislation to be introduced this week by Senator Kennedy would indeed preclude the FDA from eliminating the nicotine in cigarettes.

According to the tobacco company’s summary of the bill to be introduced: “The product standard section explicitly provides that only Congress could … require ‘the reduction of nicotine yields of a tobacco product to zero’. … In addition, a performance standard may not have the effect of … reducing nicotine yields ‘to zero.'”

In other words, Senator Kennedy and the Campaign for Tobacco-Free Kids were full of crap.

They told the American people one thing, but did exactly the opposite.

They deceived the American people in their public statements, which turned out to be little more than public relations propaganda to make them sound concerned about the rising nicotine levels that apparently are addicting our children.

But when it really came down to it, they were not only not willing to do anything about that problem, but they did the opposite of what needed to be done. They permanently institutionalized nicotine addiction of our nation’s children into the statutes of the United States (or at least they are trying to do so – not so fast, people like me and Bill Godshall aren’t going to let them get away with this quite so easily).

Now before I get criticized for calling on the elimination of nicotine from cigarettes, let me make it clear that what I view as crap is not the idea that right now, it would not be feasible for the FDA to eliminate nicotine from cigarettes and therefore that it makes sense to preclude FDA from doing just that.

That’s just an opinion about an appropriate strategy for dealing with the nicotine problem, and Senator Kennedy and the Campaign are certainly welcome to their opinions. I happen to think that it is not feasible at the present time and it would not be advantageous to eliminate nicotine from cigarettes at the present time. However, my personal opinion is that it doesn’t make sense to tie the FDA’s hands and place decisions about this issue into the realm of politics rather than science and public policy. I think one could easily avoid the problem by simply requiring the FDA to make a determination that its regulations are feasible and to consider the potential for social disruption, black markets, etc. in promulgating any regulation that would eliminate or phase out nicotine. Thus, FDA would have the authority to take such an action if it ever made sense, but would not be required to take the action.

What is crap, however, is telling the American public that the addiction of America’s children by increasing nicotine levels is a travesty that we are going to address through FDA legislation and then to go back on one’s word by not addressing that problem in the legislation, but rather, doing the opposite and making sure that the specific problem you stated was the need for the legislation will be codified into the laws of the United States.

That’s about as low a level of integrity that I can imagine. It’s worse than simply misleading the American public by making them think you’re going to do something and then not doing it. It’s worse, because you are actually making the public think you’re going to do something and then doing the exact opposite.

And to make matters worse, not only are you doing the opposite, but you are ensuring that the original action you said you would take can never be done.

For Congress to amend the tobacco legislation once it is enacted is almost unfathomable. Congress only enacts tobacco legislation to begin with every 30 years or so. Once this law is enacted, you can put a fork in it – we’re not going to see a revision of the legislation any time soon.

It’s not like I didn’t make an effort to warn Senator Kennedy and the Campaign about this. In addition to contacting both of them, my op-ed published last Sunday in the New York Times exposed the problem, and made it clear that merely reducing nicotine levels would not solve the problem. It would not eliminate the addictive potential of cigarettes and in fact, it would make cigarettes potentially far more harmful: smokers compensate to make up for reduced nicotine delivery; the increased tar delivery would increase rates of cancer and chronic lung disease.

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.

It is not actually clear yet whether the bill to be introduced by Senator Kennedy would even allow the FDA to mandate increases in nicotine levels in cigarettes. But if the legislation is similar to that introduced in the past two sessions of Congress, I do not believe it would allow this approach.

According to section 907(a)(4)(a)(i) of that legislation, the FDA could only require reductions of certain constituents in cigarettes.

In fact, in my suggested revisions to the legislation which I sent to Senator Kennedy’s office, I pointed out this problem. Specifically, I suggested the following revision:

“Section 907(a)(4)(a)(i) – Tobacco Product Standards: Tobacco Product Standards: Change the word ‘reduction’ to ‘regulation.’ This would allow FDA to regulate the overall cigarette design in terms of nicotine/tar ratios, rather than just reduce the nicotine, which would lead to compensatory increases in cigarette consumption. For example, a high nicotine/low tar cigarette could provide substantially reduced risk, as cigarette consumption might fall somewhat in combination with a reduction in carcinogen intake.”

It’s not clear to me exactly what the most reasonable and advantageous regulatory approach would be to reduce the harms of tobacco-related disease. And I would not be criticizing Senator Kennedy so harshly had he simply introduced the bill as it is. I am not criticizing him for failing to mandate the removal of nicotine from cigarettes or even for failing to grant the authority to FDA to do this. I am criticizing him for saying one thing and doing the opposite.

While I don’t necessarily call for the removal of nicotine from cigarettes, I also don’t put out press releases stating what a travesty it is that Big Tobacco is increasing their nicotine levels, showing how this demonstrates a need for FDA regulation, and promising to introduce or support legislation to address this problem, and then go out and make sure, behind the public’s back, that the legislation contains language that precludes the FDA from addressing the problem.

It’s quite interesting that Philip Morris apparently had detailed knowledge of the provisions of the bill before any of us in the public. Philip Morris was at the negotiating table that produced this deal in the first place a couple of years ago. And apparently, their support of the legislation (i.e., assured financial stability and increased market share) is far more important to those supporting it than the integrity and honesty in public statements and the actual health protection of the public.

In summary, what’s very clear to me is that those who are pretending to take the responsibility for the public’s health onto their shoulders and protect us from the hazards of cigarettes do not have a clue about the real scientific and public policy issues involved with the regulation of cigarettes – something I have personally been studying for the past 21 years and think I have a little bit of expertise in.

Not only that, but in pretending to be protecting us from the travesty of the addiction of our nation’s children with the use of nicotine in cigarette products, Senator Kennedy and the Campaign for Tobacco-Free Kids are pulling the wool over the eyes of the public. They are saying one thing, and doing precisely the opposite.

That’s not public health protection. It’s not clarity and transparency and full honesty and disclosure. But most importantly, it’s not the kind of integrity that I think we deserve from our public health organizations and our policy makers – especially when those organizations and policy makers take it upon themselves to tell us that they have the very solution to the problem they are bemoaning.

When it turns out their purported solution would actually institutionalize the very problem at hand, I think it’s time to do more than simply ask questions.

Campaign for Tobacco-Free Kids’ Campaign of Deception on FDA Legislation is Working; Public Has No Clue About Nicotine Policy Considerations