As Nicotine Dose Increases, So Must Awareness of the Pitfalls of FDA Regulation

Share this

The Harvard School of Public Health released a study [11] Thursday revealing that the amount of nicotine in cigarettes has increased significantly since the major American tobacco companies signed the Master Settlement Agreement (MSA) in 1998. Predictably, Philip Morris [12] (PM), in a media release available at their web site [13], denies the study results. The U.S. Surgeon General in 1988 [14] warned that nicotine is as addictive as heroin and cocaine, but these drugs don't have decades of sophisticated R&D behind them aimed at heightening their addictiveness. Cigarettes, among the most highly engineered consumer products in the world, deliver nicotine into more people's bodies more times every day than aspirin. Still, they remain unregulated by the U.S. Food and Drug Administration [15] (FDA).

Senator Edward Kennedy (D-Mass) is reviving legislation to give the FDA regulatory authority over cigarettes, presumably in response to the Harvard study (the second such study to show increased cigarette nicotine levels since August 2006). FDA regulation would sound like a great idea, if it wasn't first conceived and pushed by Philip Morris itself.

In a weird twist, PM has eagerly sought FDA oversight of cigarettes for years. Why? A 2001 strategy memo [16] titled "Campaign to Achieve FDA Regulation of Tobacco" reveals PM's plans to drive the institution of FDA oversight of the tobacco industry. The memo was written by John Brady of Direct Impact [17], a public relations [18] company PM retains for campaigns like organizing the company's "Options" program (which pushed ventilation as the solution to secondhand smoke). It reveals that FDA oversight is a PM corporate goal that stands to enhance PM's image and distinguish it from other tobacco companies. In a section titled "A Public Relations Opportunity," the memo states,

Though the nature of the FDA regulation issue does present some challenges for Philip Morris, we believe that is also opens an important opportunity for the company to enhance the Philip Morris corporate image...

The memo points out how the pursuit of FDA regulation will help PM by complicating tobacco issues for the public (thus graying PM's traditionally black corporate hat), and giving PM a strategic PR advantage over other tobacco companies by giving the appearance that PM is being a "good corporate citizen." The memo says,

Unfortunately for the industry, the tobacco debate in recent years suffered from oversimplification, perpetuated by media coverage that depicts tobacco-related issues as 'black and white,' with tobacco companies playing the predictable role as evil corporate giant...

It continues,

The debate over FDA reform has the potential to complicate this portrayal in a manner that will specifically benefit Philip Morris. The simple fact that other tobacco companies will likely come out on the opposite side of the issue — against FDA regulation — provides Philip Morris a chance to distinguish itself from its competitors as a good corporate citizen. Positioned appropriately, the campaign can actually serve two purposes: achieving Philip Morris's goal of instituting regulation of the tobacco industry while also realizing significant public affairs benefits.

Still another document, an internal PM email [19] from 2001 titled "FDA Research Results — Communications Testing," shows that PM has carried out focus group testing to determine whether pursuing FDA regulation will improve PM's image in the eyes of the public. The testing showed a positive result. The email states,

Impact [of pursuing FDA regulation] on PM Image: knowing PM supports FDA and after hearing reasons moves overall views of the company in the positive direction. Total 'unfavorable' drops 15%, total 'favorable' goes up 5% and 'neutral' increases 16%.

Taken together, these documents show that PM's dogged pursuit of FDA regulation is analogous to how the company has operated in the past: seizing the initiative on potentially damaging issues and carefully crafting a process to turn the issues to their favor. Based on this information, we must conclude that:

1. Philip Morris, not public health authorities, is driving the current push towards FDA regulation. This is similar to PM's past strategy of pushing its "Accommodation Program [20]" wherever possible to head off effective regulation of public smoking.
2. PM is pursuing FDA regulation according to a well-strategized plan. PM's "proactive" activities are normally well-strategized as PM tends to run approximately 10 years ahead of public health authorities. For example, the basic tenets of the Master Settlement Agreement were actually dawn up in 1991 in anticipation of a push in the U.S. for a total ban on tobacco advertising in the U.S.
3. PM is pursuing regulation at least in part for the positive public relations benefits that will accrue from such action. This tactic is similar to the motivations that previously prompted PM to institute "youth smoking prevention" programs for their public relations and legislative benefits. These programs have improved the company's standing so much that, according to the PM web site, it now has such programs in place in more than 90 countries.
4. Pursuit of FDA regulation gives PM — the largest tobacco company in the United States — a strategic image advantage, particularly among legislators, by enabling it to distinguish itself in a positive way from its competitors, who will likely oppose the regulation.
5. PM is using other strategies they have used in the past on other issues:
   • Broadening and complicating the issue (as they did with secondhand smoke) to deflect regulator's and the public's focus.
   • Tailoring messages to appeal to specific audiences (as they have done in working to defeat tax increases).
   • Using the "white hat" strategy to blur the lines between tobacco and public health.

Bottom Line: Any proposal to institute FDA regulation must be carefully scrutinized and pass a tough "smell test" by public health authorities knowledgeable about Philip Morris' clandestine activities to make sure the regulations advantage public health and not tobacco companies.