Friday, December 21, 2012

In Ironic Twist, Campaign for Tobacco-Free Kids Argues that Some Cigarettes Convey Reduced Risk, While Tobacco Companies Emphasize that All Cigarettes are Equally Hazardous

It used to be that the cigarette companies tried to convince the public that their brand - which was slightly different from other brands on the market - was safer than those other brands. Anti-smoking groups pounced on the tobacco companies, arguing that no cigarette was safer than any other cigarette, even though cigarettes differ in terms of ingredients, additives, flavorings, and smoke constituents.

In 1998, Philip Morris introduced Accord, a cigarette that heated rather than burned tobacco. Because of the absence of combustion, the cytotoxicity of the smoke produced was substantially lower than that of conventional cigarettes. Philip Morris was attacked by the anti-smoking groups, which argued that even though the Accord product was completely different in technology,  it still delivered tobacco-derived smoke and was therefore just as harmful as the company's other products.

That was in 1998.

When Winston advertised that it contains no additives (without making an explicit reduced risk claim), R.J. Reynolds was attacked by the anti-smoking groups, which placed pressure on the FTC. The Commission eventually forced R.J. Reynolds to put a disclaimer on Winston packages and advertisements emphasizing that the lack of additives does not convey any reduction in health risk.

That was in 1999.

The Rest of the Story

In 2012, the Campaign for Tobacco-Free Kids is arguing to the FDA that despite very slight differences in product design, brands of cigarettes that are not identical raise substantially different issues of public health. The Campaign is arguing that despite these very minor differences, cigarette brands that are not identical are substantially different in terms of the public health risk that they pose. Thus, the Campaign argues that such products should not be deemed substantially equivalent.

This is the opposite of the position that the Campaign and other anti-smoking groups have traditionally taken. Previously, when faced with drastic differences in product design (Winston had no additives; Accord involved no combustion), the anti-smoking groups argued that despite these drastic differences, the products were substantially equivalent with regards to the public's health.

Now, all of the sudden, even minor differences render cigarettes substantially different in terms of public health risk.

How did it come to be that major differences in cigarette design used to be of no substantial public health consequence, while today, even minor differences are of substantial public health consequence?

Quite simply, the difference is that in 2009, the Campaign for Tobacco-Free Kids and other anti-smoking groups were successful in convincing Congress to enact the Tobacco Act, and so those groups are now under pressure to make it seem like the Act is going to accomplish something in terms of public health protection. So those groups are trying to convince the public that by strictly regulating very minor changes in cigarettes, the FDA is providing enormous protection to the public's health.

In other words, the Campaign for Tobacco-Free Kids and other anti-smoking groups have reversed their public positions because it is now politically advantageous to make the opposite argument that they made previously.

In an irony of epic proportions, the tobacco companies, in responding to the FDA's proposed guidance on the interpretation of "substantial equivalence," argued that all cigarettes are equally hazardous because all involve the combustion of tobacco and so minor differences in design are not going to render any particular cigarette brand substantially safer than any other brand.

In other words, the tobacco companies adopted the precise argument that the anti-smoking groups used to make.

How ironic that there was a complete, 180-degree reversal in position:

The anti-smoking groups used to insist that even major changes in cigarette design have no appreciable impact on the public health risks of a product. Now, they argue that even minor changes result in substantially different issues of public health risk.

The tobacco companies used to imply that changes in cigarette design rendered a product safer. Now, the companies are telling the truth and acknowledging that minor changes in cigarette design are not going to have any substantial impact on protecting the public's health.

(Note: The arguments provided to the FDA by the Campaign for Tobacco-Free Kids and the tobacco companies are summarized in the following article, which I used as a source for this post: Greenwold ME [senior consultant to the Campaign for Tobacco-Free Kids]. What standards should FDA apply in ruling on applications for substantial equivalence for tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009? FDLI Food and Drug Policy Forum. Volume 2, Issue 18. September 26, 2012. Washington, DC: The Food and Drug Law Institute.)

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