The Director of the FDA's Center for Tobacco Products said last week that due to the Agency's new regulations, consumers will finally know the constituents of the tobacco smoke that they are inhaling. The rules require tobacco companies to disclose any changes to the ingredients in their products. The Tobacco Act itself requires tobacco companies to provide a list to the FDA of the ingredients, additives, and known constituents in cigarette smoke.
According to an article in the New York Times: "Federal regulators on Wednesday outlined rules for the tobacco industry that for the first time require disclosure of any changes to their products, and that detail how to seek permission to market new products under the sweeping tobacco control law signed by President Obama in June 2009. “Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming,” Dr. Lawrence R. Deyton, director of the Center for Tobacco Products of the Food and Drug Administration, said in a conference call with reporters."
Dr. Deyton's point was further emphasized in an article in Internal Medicine News, which quoted him as stating: "The ingredients of these products have not ever been known to those people who consume them."
According to an article in the Los Angeles Times, the Campaign for Tobacco-Free Kids called this new rule one of the most important actions the FDA can take on tobacco regulation: "'This may be one of the most important actions the FDA takes on tobacco regulation,' said Matthew Myers, president of the Campaign for Tobacco-Free Kids. 'They're going to get the chemistry. They've never had that before.'"
According to the Internal Medicine News article, Dr. David Ashley - director of the FDA's Center for Tobacco Products' Office of Science - stated: "The standard we work under when looking at these products is a public health standard. That is at the center of all the decisions we are making."
The Rest of the Story
In asserting that "up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," the FDA Center for Tobacco Products implies that now (after implementation of the new rules and disclosure of ingredients), users will know what they are consuming.
This assertion is incorrect and is based on a misunderstanding of tobacco science.
The rest of the story is that even after the FDA rules are implemented, consumers will still largely have no idea what is in the cigarette smoke that they are inhaling. And furthermore, the rest of the story is that right now, we know just about as much as we will after the implementation of the law about the constituents of cigarette smoke.
The law will add virtually nothing to our understanding of the constituents in cigarette smoke and after its implementation, consumers will still largely have no idea what is in the cigarette smoke that they inhale.
Why? Because of these two facts that the FDA's Center for Tobacco Products has overlooked:
1. We already know about 8,400 of the chemicals in cigarette smoke, but that knowledge does nothing for our ability to make a difference in smoking-related disease. The tobacco companies' disclosures will add very little to this list that we already have.
2. While only about 8,400 of the chemicals in cigarette smoke have been identified, there are as many as 100,000 chemicals in the smoke. Thus, even after the tobacco company disclosures, we will still only have identified about 8.4% of the chemicals in cigarette smoke. Thus, consumers will still essentially have no idea what they are inhaling.
According to an authoritative textbook on the chemical components of tobacco and tobacco smoke written by two eminent R.J. Reynolds analytic chemists, consumers will never know what is in the smoke they are inhaling because there are as many as 100,000 chemicals in the smoke -- most of which have not even been identified (see: Rodgman A, Perfetti TA. The Chemical Components of Tobacco and Tobacco Smoke. Boca Raton, FL: CRC Press, 2008).
Perhaps we should all chip in and buy a copy of the book for the FDA's Center for Tobacco Products. It's only $273.38 on Amazon, and it ships free with Super Saver Shipping. If 100 readers are willing to put in two bucks each, I'll throw in the other $73.38. Only three are left in stock so we better act quickly.
In the book, Rodgman and Perfetti review and catalog over 8400 tobacco and tobacco smoke components (this is substantially more than the 4,000 chemicals number that is typically cited). According to these R.J. Reynolds scientists, cigarette smoke alone contains more than 5300 chemicals: "The number of identified components in cigarette tobacco smoke has increased almost 100-fold from the fifty definitively identified tobacco smoke components listed by Kosak to the more than 5300 components identified to date and cataloged by RJRT personnel."
Importantly, however, these R.J. Reynolds chemists note that the actual number of constituents in tobacco smoke is most likely much higher, because for every identified chemical, there are probably many more unidentified ones: "Despite the identification of over 5200 additional smoke components since the 1954 listing by Kosak, various investigators have estimated from gas chromatographic scans that for each component identified in tobacco smoke there are five to twenty components present at extremely low per cigarette yields that have not yet been identified."
In fact, Rodgman and Perfetti cite gas chromatographic evidence that the true number of constituents in tobacco and tobacco smoke is probably more than 10,000 and may even be as high as 100,000: "Gas chromatographic scans indicate there are many more, probably over ten thousand, possibly even a hundred thousand tobacco smoke components."
The most important implication of the science of tobacco smoke is that it exposes the absurdity of the FDA's tobacco regulatory approach. The best the FDA can do is to regulate the levels of a few of the 100,000 chemicals in tobacco smoke. Moreover, the overwhelming majority of the chemicals in tobacco smoke have not even been identified. So how can the FDA hope to improve the safety of the product by removing or lowering the levels of just a few of the identified components? We don't even know what the majority of the chemicals in tobacco smoke are and we have no idea what role these unidentified chemicals play in the health effects of cigarette smoking.
When you have a product with as many as 100,000 chemical constituents, regulating the levels of a select few of these constituents is simply not a reasonable, sensible, science-based approach to the problem. The Tobacco Act is not a science-based policy. It is a pure political maneuver, designed to have the appearance of being a bona fide health measure, but in reality being a complete scam that institutionalizes cigarettes, creates an FDA seal of approval for cigarettes, and protects existing cigarette products from competition from potentially safer ones.
A second important implication of this science is that it makes absolutely no contribution to the public's health to require the cigarette companies to disclose the components of cigarettes. Consumers will not be informed about the exact constituents in the smoke they are inhaling. In fact, they will not be aware of most of the components in the smoke. There will remain as many as 96,000 or so chemicals in their smoke about which they are not informed. The cigarette companies do not even know most of the constituents in tobacco smoke.
But more importantly, what possible use is it for consumers to have this information? Frankly, the information is already available. Anyone interested can just read Dr. Rodgman's and Dr. Perfetti's excellent book. The known components are beautifully and exquisitely cataloged.
But what difference does this make? How does it change anything? How does it contribute in any way to the protection of the public's health? The whole idea makes no sense.
This is what makes so comedic the Campaign for Tobacco-Free Kids' statement that this is the most important regulatory action that the FDA can take. In reality, this action is a waste of time. It does nothing to protect the public's health. All that it accomplishes is to give the public a false sense of security about the safety of cigarettes.
The ultimate absurdity is the Center for Tobacco Products' statement that "the standard we work under when looking at these products is a public health standard." What kind of crazy public health standard says that as long as you have a product that includes the same chemical mix that is already killing hundreds of thousands of Americans each year, you're fine to continue marketing and selling them? What kind of public health standard accepts 400,000 deaths per year and is designed simply to make sure that the number doesn't increase?
Clearly, I must have missed that lesson during my public health training. That must have been the day I climbed out the window and skipped class.
The FDA's regulatory approach to tobacco products is a joke. It would be funny if not for the fact that hundreds of thousands of Americans will continue to die each year from the products which this Agency is now going to officially approve for marketing and sale in the United States.