Wednesday, July 27, 2005

Campaign for Tobacco-Free Kids Blasts R.J. Reynolds' Claim that Substantial Reductions in Smoke Constituents Reduce Health Risks

The Campaign for Tobacco-Free Kids yesterday blasted R.J. Reynolds for making a claim that a product which greatly reduces levels of a large number of tobacco smoke constituents will reduce health risks.

The Campaign accused R.J. Reynolds of false and deceptive advertising in marketing its Eclipse cigarette as one that might reduce health risks, such as cancer and chronic lung disease. Eclipse is a cigarette that heats, but does not burn tobacco, and which therefore has substantially lower levels of a number of carcinogenic and toxic smoke constituents.

According to the Campaign's statement: "RJR's unsubstantiated claims that Eclipse cigarettes 'may present less risk of cancer' and other serious diseases is just another example of how the cigarette companies have continued to make misleading statements about the health risks of their products. ... as study after study has found, there is no scientific basis for concluding that Eclipse cigarettes or any of the other so-called reduced risk products that have been marketed by R.J. Reynolds or the other tobacco companies have actually reduced the risk of tobacco related disease."

The Rest of the Story

This is an important story, because it documents that the Campaign for Tobacco-Free Kids is admitting that reducing, even by a substantial amount, a large number of carcinogenic and toxic constituents in tobacco smoke does not provide any substantiation that a tobacco product will be any safer.

If this is true, then there is also no substantiation that the performance standards in the FDA tobacco legislation that the Campaign is pushing would make cigarettes any safer, as the Campaign claims. After all, the performance standards would allow FDA to reduce or eliminate a number of the more than 40 carcinogens and more than 4,000 toxins in tobacco smoke. But that is precisely what R.J. Reynolds has done with its Eclipse cigarette!

For example, Eclipse produces mainstream smoke levels of the following chemicals that are between 80% and 95% lower than conventional cigarettes: isoprene, acetone, hydrogen cyanide, toluene, 1,3-butadiene, benzene, acrylonitrile, quinoline, NAT, NNN, catechol, hydroquinone, phenol, benzo(a)pyrene, and 2-aminonaphthalene.

I am not claiming that the Campaign is wrong in its assessment that reducing a large number of tobacco smoke constituents by a great amount does not provide any reason to conclude that a cigarette will be safer, as anyone who has read my previous post on this issue will recognize. But I am arguing that if the Campaign applies this correct reasoning to R.J. Reynolds' claims, then it should also apply the same reasoning to its own claims.

The Campaign, in fact, claims that the FDA legislation (through its performance standards) would "require changes in tobacco products to make them less harmful." This implies that eliminating or reducing the levels of certain tobacco smoke constituents will make cigarettes less harmful, since that is exactly what the performance standards are.

Until and unless the Campaign can provide some evidence that reducing the levels of certain tobacco smoke constituents will reduce human health risks, then it should cease and desist from making what amount to unsubstantiated health claims of its own. Is is not hypocritical for the Campaign to condemn R.J. Reynolds for making unsubstantiated health claims based on an assumption that huge reductions in tobacco smoke constituents will produce a safer product, but to use that very same reasoning to support legislation that it wants to see passed?

The rest of the story reveals that the Campaign for Tobacco-Free Kids - an organization which is relentlessly criticizing the tobacco companies for making misleading claims - is itself making an unsubstantiated claim -- and that claim is based on the same flawed reasoning that R.J. Reynolds is using to argue that its Eclipse cigarettes will reduce health risks. And now, the Campaign has itself admitted that this very reasoning is scientifically inappropriate.

R.J. Reynolds should certainly be held responsible for its misleading health claims, but so should the Campaign for Tobacco-Free Kids, an anti-smoking organization which, by its own admission, agrees that substantially reducing the levels of large numbers of tobacco smoke constituents does not imply any degree of reduced health risk.

5 comments:

Mrs. Non-Gorilla said...

mike, i'm fascinated by the size of the bone you have to pick with TFK. one would be forgiven for thinking your attacks are personal, rather than based in an honest difference of opinion.

being a highly educated health professional, it was undoubtedly a slip of the fingertips when you wrote that giving the FDA authority to "require changes in tobacco products to make them less harmful... implies that eliminating or reducing" certain constituents would do so. i believe what you intended to type is "i infer that TFK is claiming that eliminating or reducing the levels... will make cigarettes less harmful..."

if i'm mistaken, then it is quite a leap you're making from one statement to the next -- not to mention narrow in scope and entirely misrepresentative of TFK's position, which has been clearly articulated in their many statements & releases.

i'm particularly perplexed by your failure to address the real issue raised here -- how tobacco companies should be allowed to advertisse their products -- and your creation of a strawman to lambast TFK. it certainly makes me wonder if your objective with this blog is to enlighten the public (a needed service) or to bash mainstream tobacco control organizations for some personal reason.

in my opinion, your criticism of TFK would be more honest (and in line with your criticisms of ANR's "industry lawyer" paintbrush) if you had taken issue with TFK's bashing of RJR for using a truthful statement to advertise its products. after all, stating that eclipse "may present less risk of cancer" is facially correct. RJR isn't claiming that the product does pose less risk, just that it might. because they've reduced some carcinogenic smoke constituents. if consumers want to take the chance that it might be less harmful, that's up to them. after all (and i'm playing devil's advocate here), what harm could possibly come from giving consumers more information about this new product? shouldn't they be allowed to base their purchasing decisions on as much information as possible? that is the real issue at hand.

by focusing on a fabricated claim that TFK is trying to have it two ways with respect to product regulation, you are doing a disservice to the readers of your blog who may actually be trying to inform themselves about cigarettes, tobacco control, and as you put it, "the rest of the story." your presentation of the issues seriously calls into question your objectivity as a physician and public health advocate.

Michael Siegel said...

It was most certainly not a slip of the finger when I wrote that TFK's claim that the FDA legislation gives FDA the authority to require changes in cigarettes to make them less harmful implies that the performance standards would do so, because if you read the legislation, there is NOTHING ELSE in the legislation that relates to making the product less harmful. It is really the performance standards that are the only regulatory approach by which the product could potentially be made less harmful.

If you are suggesting another mechanism by which the FDA legislation could produce safer cigarettes, then by all means - please educate us about what it is that we are missing in the legislation.

Finally, if you wish to make a claim that the analysis here is not based on a difference of opinion, but on something personal, then you'll need to document that or at least present some credible evidence for the claim. Suggesting it doesn't make it so.

Mrs. Non-Gorilla said...

perhaps i'm reading too much into the legislation, but §907 seems pretty clear to me. specifically:


(3) TOBACCO PRODUCT STANDARDS.—The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This finding shall be determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product, and taking into account—

     (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

     (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

(4) CONTENT OF TOBACCO PRODUCT STANDARDS.—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;
          (ii) for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; or
          (iii) relating to any other requirement under (B);

     (B) shall, where appropriate for the protection of the public health, include—

          (i) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product;
...
          (iii) provisions for the measurement of the tobacco product characteristics of the tobacco product;

§907(4)(A)(iii) pretty much gives the FDA carte blanche regulate all the product characteristics of tobacco products, not just the emissions/constituents. and who knows -- maybe someday researchers will find that changes to the construction of tobacco products will make them less harmful.

also, paragraph (4)(A) REQUIRES that provisions be "appropriate for the protection of the public health." taken together, these pretty much kill your assertion that (a) the legislation only gives the FDA the authority to regulate the constituents and emissions; and (b) the authority to regulate said constituents and emission implies doing so is effective. what the legislation DOES do is give the FDA authority do so IF doing so were appropriate for the protection of the public health. who knows -- perhaps someday scientists will figure out that certain reductions do, in fact, make cigarettes less hazardous.

as for your final paragraph, i'll paraphrase shakespeare: methinks the doctor doth protest too much. why won't you address the real question, which relates to how tobacco companies should be allowed to market their products?

Michael Siegel said...

Jenny,
Thanks for these comments, and especially for citing the specific provisions of the legislation, which makes it much easier to discuss the relevant issues.

Your point that FDA is given authority to regulate not only the tobacco smoke consituents, but also the additives, ingredients, and construction of the product is well-taken and accurate. But ultimately, any changes in additives, ingredients, or construction will ultimately have an effect on health by reducing human exposure to the carcinogenic and toxic substances in the smoke. I wasn't intending to imply that changes in ingredients, additives, and construction were not allowed, and took the liberty of just classifying all these changes as changes which would essentially reduce or eliminate certain toxic or carcinogenic exposures in the smoke, which I think is accurate. But your criticism of my not being detailed and specific enough is quite fair.

As to the bottom line, I quite agree with your assessment: "who knows -- maybe someday researchers will find that changes to the construction of tobacco products will make them less harmful."

AND

"who knows -- perhaps someday scientists will figure out that certain reductions do, in fact, make cigarettes less hazardous."

You're exactly right. SOME DAY, there may be evidence that changes are possible that would make cigarettes safer. But as of RIGHT NOW, I'm not aware of any such evidence. We simply do not understand enough about the specific relationship between each of the toxins to which smokers are exposed and the causation of each of the various diseases associated with smoking.

Therefore, I contend that we do not have, at present, any adequate substantiation to claim that the FDA performance standards will produce a safer cigarette, reduce health risks associated with smoking, and save lives. That's where I think the TFK claims go too far - obviously, it's my interpretation of what the TFK implies. But I think, based on my discussions with huge numbers of advocates in the field, that the TFK claim is being essentially interpreted as implying that cigarettes are going to be safer if the FDA legislation is enacted, and I don't believe there is much of any evidence at all to support such a contention.

The argument you make (that who knows, maybe some day we'll find out that reductions in constituents will reduce disease) could just as easily be made (and probably will) by R.J. Reynolds in defending its "misleading' advertising claims.

This is precisely where I think TFK is trying to have it both ways. They can't, on the one hand, use this reasoning (maybe some day it will be shown to be less harmful) to defend its claim that the FDA legislation is going to make cigarettes safer, but at the same time, deny R.J. Reynolds from using the exact same claim to defend itself in the litigation.

Actually, they could have allowed R.J. Reynolds to make such a claim, but the press release the other day, in my opinion, denies any such claim because it accuses R.J. Reynolds of deceptive and misleading advertising.

I hope that helps to clarify my reasoning and I do apologize if my writing on this issue has not been clear or has caused confusion.

Michael Siegel said...

Jenny,
Since you were kind enough to be thorough and detailed in your comment, let me explain exactly why I think that the TFK claim is inappropriate.

What it sounds like you are saying is that TFK is not claiming that the performance standards will make cigarettes safer, but that they will simply give FDA authority to require changes that WOULD make cigarettes safer IF the evidence some day shows that is possible.

The problem is, that's not what TFK has stated to the public.

TFK has stated that the FDA legislation would give FDA the authority to "require changes in tobacco products to make them less harmful." There is no conditionality in this statement. There is an implicit assumption that if FDA has the authority to require changes in tobacco products to make them less harmful then therefore, there must exist a way for FDA to require changes in tobacco products to make them less harmful.

The claim does not say that the legislation would require changes in tobacco products that COULD possibly make them less harmful." Or that the legislation would require changes in tobacco products SHOULD IT TURN OUT that research shows that such changes would make cigarettes less harmful." Or, even better, that the FDA legislation would require changes in tobacco products to reduce the levels of exposure to certain toxic and carcinogenic substances."

This latter claim would, in my opinion, be the most accurate, and I would have no problem at all if that's what TFK had claimed.

But it's not - they claimed that the legislation gives FDA authority to require changes in tobacco products TO MAKE THEM LESS HARMFUL.

Why couldn't TFK be more accurate and simply state that the legislation gives FDA authority to require changes in tobacco prodcuts that would reduce exposure to certain toxins and carcinogens? Or that the legislation would give FDA authority to require changes that COULD possibly make cigarettes safer? Or that the legislation gives FDA authority to require changes that WOULD make cigarettes safer IF, some day, there is evidence that reducing exposure to certain substances results in a safer product?

Bottom line is that regardless of what I think, I am fairly sure that the TFK claim is misleading many tobacco control advocates, because based on my extensive discussions with large numbers of these advocates, there is a very wide misunderstanding out there in the field, in that advocates seem to think that the FDA legislation ensures that the product is going to be safer, due to the performance standards.