Saturday, May 07, 2005

Campaign for Tobacco-Free Kids Continues to Mislead the Public about Flawed FDA Bill; This Time, University of Minnesota Report is the Stimulus

In a press release issued Wednesday, the Campaign for Tobacco-Free Kids used the results of a University of Minnesota report on potential reduced exposure products (PREPS) to support the current FDA tobacco legislation that is pending in Congress. The Campaign relied upon two key findings of the report -- its conclusion that there is no evidence any current PREPS actually reduce disease risk and its assertion that regulation of tobacco products is necessary to prevent unsubstantiated health claims regarding PREPS -- to support its promotion not only of the idea of regulation of tobacco products, but specifically its promotion of FDA regulation of tobacco under S.666 and H.R.1376.

In the release, the Campaign states: "this legislation would prohibit any health claims about tobacco products unless the FDA determines both that these claims are scientifically substantiated and that they would not discourage current tobacco users from quitting or encourage new users to start." The Campaign also states that the legislation would give FDA the authority to "crack down on tobacco marketing and sales to kids," and "require changes in tobacco products to make them less harmful."

The Rest of the Story

What is most interesting about the Campaign's press release is not what it says, but what it hides from the reader.

First, the Campaign claims that the FDA legislation would prohibit health claims about reduced exposure products unless the FDA determines that these claims are scientifically substantiated. However, if one reads the actual bill, it is clear that reduced exposure products can make health claims without scientific substantiation of actual health benefits. The legislation (under section 901[g][2][B]) merely requires that two criteria be met:
  • "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);" and
  • "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."
The first criterion, that scientific evidence is not available, will almost always be the case, as suggested by the University of Minnesota report, which emphasizes that "we do not know the extent of toxin exposure reduction that is necessary to result in reduction of disease."

The second criterion, that a tobacco company must anticipate that a product would, in the future, result in a health benefit, is equally easy to meet. After all, the word "anticipate" is defined in this context as "to expect." So all a tobacco company has to do is state that it "expects" a health benefit in the future and it has basically met this criterion. How easy is it going to be for a public health group to demonstrate that in fact, a tobacco company does not expect a health benefit?

The problem is that the Campaign for Tobacco-Free Kids is relying upon one small provision in the legislation that dictates reduced risk claims (section 901[g][1]), but largely ignoring a separate provision that applies to reduced exposure claims (section 901[g][2]). In fact, 901(g)(2) allows reduced exposure claims to be made with little, if any, substantiation of a health benefit.

Second, the Campaign claims that the FDA legislation would allow reduced exposure health claims to be made only if they "would not discourage current tobacco users from quitting or encourage new users to start." But the actual legislation (section 901[g][2][B][iv]) requires merely that: "approval of the application is expected to 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."

Thus, a tobacco company merely has to show that the benefits of a potentially reduced risk product in terms of future health are expected to outweight any costs related to smokers being less likely to quit or youths being more likely to start because of the reduced risk product being available. NOWHERE in the legislation does it state that such a health claim can be made only if the claim would not discourage smokers from quitting or encourage youths to start.

The Campaign has completely pulled that out of the blue, and they are using it to try to pull the wool over the eyes of the public as well as their own constituents. This is not only inaccurate and misleading, but it is disingenuous and does a disservice to thousands of tobacco control and public health advocates who are relying on the Campaign for some semblance of an accurate and objective accounting of the legislation.

Third, the Campaign claims that the legislation would give FDA the power to crack down on marketing to youths. However, the Campaign fails to inform the public that the Supreme Court of the United States has made it clear that any broad advertising regulation, such as would be necessary to "crack down" on marketing to youths, is likely to be viewed as violating the freedom of speech provisions of the First Amendment to the United States Constitution.

I find it misleading and disingenous for the Campaign to make promises about the power this legislation is going to give to FDA to curtail advertising when the truth is that there is likely very little substantial impact that FDA could have on such advertising given the limitations of the Supreme Court's holdings. Unless the Campaign can either change the United States Constitution or change the interpretation of Constitutional law, then it should cease and desist from making claims to the public and to public health advocates that are simply not reasonable.

Finally, the Campaign claims that the legislation would give FDA authority to "require changes in tobacco products to make them less harmful." However, the Campaign has failed to suggest even one change that it would recommend and to provide any evidence that such a change would actually result in a safer product. Until and unless the Campaign can provide some evidence for the health impact of a specific recommended performance standard it should cease and desist from making what amount to unsubstantiated health claims of its own.

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 a continuing string of misleading, inaccurate, unsubstantiated, and disingenous claims about what the FDA tobacco legislation does.

What possible credibility will the Campaign have to question the misleading claims of the tobacco industry if it continues its pattern of widespread deception of the public and of its own constituents about the FDA tobacco legislation?

I suggest it will lose all credibility, unless the Campaign immediately ceases and desists from its continued misleading, inaccurate, and disingenuous claims about this harmful and severely flawed FDA tobacco legislation.

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