Is Philip Morris Driving the FDA Regulation Train?

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Philip Morris (PM) is a sophisticated company that runs at least ten years ahead of public health authorities in devising strategies to shape its destiny and preserve its future markets. PM knew that sooner or later push would come to shove and public pressure would make the U.S. government try to regulate its products and corporate behavior, especially after the U.S. Department of Justice found PM guilty of 50 years of conspiracy to defraud the public about the dangers of its products. True to form, in 1999 PM started an internal project called the Regulatory Strategy Project to enact Food and Drug Administration (FDA) regulations on the company's own terms. During the project, in 2000, PM generated a "Privileged and Confidential" document listing what the company would require in what it sees as "sensible" FDA regulations.

The document is heavily edited by John Holleran of Philip Morris Management's Legal Department, and states, "We [PM] support strong but sensible FDA regulation of cigarettes based on five core principles."

The first principal is that FDA "not infringe on the right of adult Americans to choose to take the risks of smoking" and that FDA be prohibited from banning cigarettes and having the power to alter cigarettes to make smoking unpalatable to smokers. This principal would both preserve a market for cigarettes and assure that cigarettes remain available.

The second requirement is that FDA regulate cigarette design and manufacturing processes "to assure that no additives increase the inherent risks of smoking" and that cigarette ingredients be "fully disclosed to FDA in a framework that protects trade secrets." The simultaneous requirements of full disclosure and maintaining trade secrets seem contradictory, since "full disclosure" means the absence of secrets.

The third principle says that "The long-range goal of FDA regulation should be to reduce the risks of smoking by encouraging industry innovations," and that "FDA should set standards that allow products to be certified as 'reduced risk' and marketed as 'reduced risk.'" This measure would appear to have a goal of transferring liability for tobacco products onto the FDA.

The fourth principle PM requires is that FDA "assure continuous, updated disclosures to smokers as science evolves so that people continue to be fully informed of the risks of smoking." As it is written, this measure presumes that smokers are already fully informed about the risks of smoking, and places the burden of public health education about tobacco products onto FDA and takes it off the manufacturers.

Two alternatives are listed for the fifth requirement, which nominally claims to address youth smoking:

"5. (Alternative 1) In the area of youth smoking prevention, FDA should set policies that acknowledge the significant changes created by the MSA (Master Settlement Agreement) and, like the MSA, recognize the legitimacy of marketing communications to adult smokers..."

The first alternative further says that, "Marketing to adults...should not be regulated by the FDA." Instead of addressing youth smoking as the introduction suggests, this principle appears to be aimed at protecting marketing to adults.

The second version of principle number five says, "FDA should NOT be given a specific regulatory responsibility regarding how cigarettes are marketed and sold. Through the [Master Settlement Agreement], states have a strong legal framework for preventing tobacco marketing to youth. The FDA's mission is and should be scientific in nature -- focusing on the products and its risks." The document threatens to embark on a Constitutional legal challenge if FDA makes any effort to regulate tobacco marketing. This version also says, somewhat haughtily, "There is no need for the FDA to use its scarce resources on youth smoking prevention. That is best left to others."

This paper represents the starting point for laying out the elements of what PM wants in its preferred FDA regulation. Taken as a whole, the document indicates that PM's goals in pressing for FDA regulation are:

1) To assure a future market for cigarettes,

2) To preserve the company's ability to make cigarettes that appeal to their market,

3) To safeguard the ability to market cigarettes without restrictions,

4) To keep FDA from engaging in smoking prevention efforts, particularly among youth,

6) To prevent FDA from obtaining any authority to restrict the marketing and promotion of cigarettes,

7) To give FDA the responsibility of fully informing the public about the dangers of tobacco use, rather than the manufacturers,

8) To transfer legal liability for the safety of tobacco products onto the FDA, while allowing cigarette companies to continue to design and market cigarettes as they see fit.

Of course, all the principles PM laid out in this document serve to protect the cigarette business rather than public health. While the major health groups and Philip Morris currently are the only groups that are privy to the text of the recently-introduced Kennedy/Waxman bill to regulate tobacco, it would be prudent when the bill becomes available to see how many of PM's Core Principles are in it. If they are, the bill will benefit Philip Morris, and be detrimental to effective future regulation of tobacco.