What Philip Morris Seeks in FDA Regulation: Preservation of the Status Quo

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A 23-page, formerly "privileged and confidential" company discussion document outlines Philip Morris' thinking behind its 180-degree turn from strongly opposing U.S. Food and Drug Administration (FDA) oversight of cigarettes to in fact driving such regulation. It clues us in to the company's logic in proceeding down this path and what the company hopes for and fears most in FDA regulation. It was written by Mark Berlind, who was Assistant General Counsel of Philip Morris Worldwide Regulatory Affairs in 1998.

Berlind recaps PM's history of opposing FDA regulation and recommends that PM USA advocate for regulation as a way to maintain the status quo, or "perpetuate the existing framework's philosophy that adults continue to be permitted to assume" the inherent risks of cigarette smoking. Berlind supported the:

...enactment of a new regulatory regime that would (a) permit the federal government to assure itself that the industry's design and manufacturing processes do not exacerbate the inherent risks of cigarette smoking and (b) perpetuate the existing framework's philosophy that adults should continue to be permitted to assume — without governmental interference — those risks so long as they have been adequately informed of them. In addition, [this paper] will recommend that the company continue to support federal measures legitimately aimed at reducing youth access to cigarettes, and oppose proposals that would infringe on its First Amendment rights without its consent.

Berlind compares potential regulatory regimes for cigarettes to consumer safety regimes that have been applied to other risky products, such as high fat foods, guns, alcohol and gambling. Among these Berlind finds "no instance in which the government has established a regime that would permit unelected agencies to either ban the product or mandate significant design changes intended to reduce consumer risk." Berlind concludes that rather than banning products, the FDA's role instead has been "on labeling and ensuring that consumers are not misled." He points out that the gun industry is "largely unregulated," and that the few restrictions placed upon guns were created by legislative action and not regulatory action. He states with respect to guns that "current law largely leaves it to consumers to discern the riskiness of the products by themselves."

Berlind also observes that gambling laws

are not directed nearly as much at trying to discourage gambling as they are at ensuring that only state-sanctioned (or sponsored) gambling occurs, and that the revenues are directed through the proper channels. The view that gambling is addictive and socially destructive does not, however, seem to have dampened official enthusiasm for perpetuating the practice.

With regard to alcohol, Berlind states that while many laws exist regulating misleading brand names, posting of health warnings, prohibitions on false statements, etc., "there are no regulations whatsoever on product design or manufacture of alcoholic beverages either at the state or federal level. No agency is charged with the responsibility of attempting to reduce alcohol consumption by adults. ... The prevailing philosophy appears to be that ... even though the product allegedly can impair health and has been characterized as addictive, the consumer should be left along to decide to consume alcohol or not, in accordance with his or her individual preferences."

After these comparisons, Berlind says the FDA's "safe and effective" requirement for regulated products would be "troubling," saying that FDA is required to ban any drug or medical device not found to be safe and effective. "Unless the law is amended, FDA jurisdiction over tobacco products could ultimately lead to a new Prohibition." Berlind concludes that "sensible regulation would continue to permit adults to assume the inherent risks of smoking, while allocating to the government the twin tasks of ensuring that manufacturers don't create additional risk though their design and manufacturing processes, on the one hand, and continuing to conduct appropriate research about the nature of the inherent risks and keeping consumers informed of them, on the other."

These limited parameters for regulation appear to be the broad goals PM seeks in FDA regulation. It intends that regulation will generally preserve the status quo of "adult choice" about smoking; assure that cigarette manufacturers don't create any more risks than their products already pose; place FDA in charge of informing citizens about the risks of smoking; and prevent FDA from getting any authority to reduce or eliminate any naturally-occurring harmful constituents in cigarettes (by relegating this power only to Congress).

In the 50 or so years since science unequivocally determined that tobacco smoke causes disease and death, smoking rates in the U.S. have only dropped by about half. If the currently-proposed bill to have FDA regulate tobacco preserves the status quo, then smoking rates will continue to fall at a painstakingly slow rate. That will be bad for public health, but great for Philip Morris.