The Untold Story of How & Why Philip Morris is Pushing for FDA Regulation

Congrats Philip MorrisIt may seem incongruous to the average person why Philip Morris (PM) would back legislation to restrict its business, yet that is what PM seems to be is doing by supporting S. 625, the "Family Smoking Prevention and Tobacco Control Act," the bill that would give the U.S. Food and Drug Administration (FDA) authority over tobacco products. After all, PM has a corporate mandate to increase profits for its shareholders, so PM would not support this legislation if it wasn't going to benefit its bottom line, and it is practically an axiom in public health that whatever benefits PM's bottom line is going to be bad for public health. That's what makes this bill especially troubling to people who study tobacco industry documents; it is clear that PM had a hand in crafting it. That alone sounds like a lot, but PM's efforts to enact it are clearly delivering the company a hefty side-benefit of causing dissent within the tobacco control community over its passage.

Neither the content of the bill nor the strident disagreement about it among tobacco control professionals is happenstance.

PM's efforts to both weaken the tobacco control community and pass FDA legislation slanted in its favor started in the mid-1990s. A 1995 PM report titled simply "Mission," states that "Because some form of [legislated] restriction is inevitable, it's better to shape the agenda than to stand pat and fight." The report indicates that PM believed that it had just two alternatives: "Fighting inch by inch against every initiative launched by the other side, or try an end run/proactive initiative, because the next 'firestorm' could cause a major meltdown."

Believing the "end run" option was the only viable escape for the company, PM employees started developing a comprehensive, 10-20 year strategy to "hold the line" on tobacco regulation and preserve the social acceptability of smoking.

Industry documents make it clear that PM fears specific legislative or regulatory measures that:

  1. accelerate the decline in the social acceptability of smoking, for example laws that restrict smoking in public places or reduce modeling of smoking by celebrities on TV and in the movies;
  2. end tobacco company advertising and sponsorship, because this would end tobacco company access to powerful third parties who, heavily dependent upon tobacco funds, reliably defend the industry's interests;
  3. limit branding and packaging distinctions, because cigarette companies rely on ad imagery and package design to sell certain brands to different market segments. For example, Marlboro and Camel are targeted at men, Virginia Slims and Misty are targeted at women, a marketing strategy called "segmentation" that benefits sales;
  4. treat tobacco like an addiction, for example by mandating free nicotine cessation treatment be made available to all users, or that make nicotine-containing products available by prescription only;
  5. make cigarettes unpalatable or unaddictive, because then people would be able to more easily stop using them; and
  6. address the additional harmful "externalities" of smoking, like litter and cigarette-caused fires, since the industry does not want to draw attention to these additional wholly negative and costly aspects of smoking.

The FDA legislation PM is now pushing to enact will likely harm the company little if at all, and is quite likely to benefit the company in the long run. For example, industry documents show that PM seeks provisions that

  1. put the burden of disclosing the health hazards of smoking onto a third party (which takes liability off the companies);
  2. put the burden of reducing the risks of smoking onto a third party (which also takes liability off the companies);
  3. involve self-regulation (because then they won't);
  4. emphasize unenforceable or minimally enforceable voluntary agreements, like the Master Settlement Agreement, which has had little if any appreciable effect on reducing smoking;
  5. force regulators to consider the economic impact of their actions on tobacco companies and their associated businesses; and
  6. reinforce the notion that smoking is a free choice and not an addiction-enforced activity.

The proposed FDA regulations hand PM many, and probably most, of its preferred measures.

PM's Project Sunrise: PM's Plan to Weaken Tobacco Control Forces by Dividing Them

In 1996 PM carried out a "visioning exercise" called "Project Sunrise," in which employees of Philip Morris Corporate Affairs and other departments considered a panoply of future regulatory and social scenarios, each increasingly grim. The grimmest scenarios were assigned names like "Avalanche" and "Blade Runner." Through this "visioning" exercise, PM concluded that the company had to deal with "the antis" (public health advocates) by weakening their credibility and dividing their ranks.

Sure enough, an additional bonus of PM's pursuit of FDA regulation is that its efforts are fracturing the tobacco control community, just as PM planned.

Public Health Advocates are The "Anti-Tobacco Industry"

The same year PM engaged in Project Sunrise, it also developed its "Anti-Tobacco Industry Plan" (or "ATI Plan"), a long-term strategy designed to hobble public health efforts to reduce smoking. PM sought to position the company as being reasonable and responsible while minimizing the other side's ability to engage in efforts to reduce smoking. PM's ATI plan states,

Our Fourth Strategy focuses on efforts to cause dissention [sic] within the ATI [Anti-Tobacco Industry]:

1) As the tobacco company that is seeking "reasonable solutions to complex problems" we want to reach out to members of the ATI where we can potentially establish Common Ground -- such as on the issue of preventing youth access to tobacco products.

2) We also want to enhance internal conflicts that already exist within the ATI -- and possibly encourage some new ones.

Josh Slavitt, PM's Director of Policies and Programs, described PM's tactics in more detail:

Form relationships with anti-tobacco groups that are the most amenable to this company's positions in order to enhance our credibility by demonstrating our ability to seek realistic solutions on tobacco-related issues. In addition, build relationships with so-called "moderate" anti-tobacco groups in order to disrupt the ATI's cohesion and create opportunities to focus attention on prohibitionists.

Equating tobacco control advocacy with prohibition in the public mind is a longtime tobacco industry tactic to weaken public health, and was the aim of a long-running national campaign by R.J. Reynolds called Project Breakthrough.

PM's efforts have tracked closely with its ATI plan. PM approached the National Campaign for Tobacco-Free Kids (CTFK) seeking input to formulate its preferred FDA regulations. As the Plan mentioned, PM found common ground with CTFK on the youth smoking issue, and engaged CTFK in its Regulatory Strategy Project to craft FDA regulations in its favor.

Now CTFK is helping PM stump for passage of a bill that many highly experienced tobacco control people and organizations consider deeply flawed in many respects. An article in the October 5, 2004 edition of Roll Call, the newspaper of Capitol Hill, titled "How Philip Morris, Tobacco Foes Tied the Knot," describes the uncomfortable first meeting between Matt Myers, President and Chief Executive Officer of the Campaign for Tobacco Free Kids, and Mark Berlind, Associate General Counsel of Philip Morris, and the subsequent secret negotiations the two parties carried on without notifying others in the tobacco control community:

Thanks to separate but equally calculated decisions by Philip Morris and the Campaign for Tobacco Free Kids, each has broken ranks with their typical allies, formed a secret alliance and met clandestinely to iron out key sticking points on the legislation...The face-to-face negotiating sessions and conference calls were so sensitive that Philip Morris and the Campaign for Tobacco Free Kids refused to tell even their closest allies...Unbeknownst to their allies in the public health community, representatives of the Tobacco Free Kids spoke with Philip Morris lobbyists several times and met at least once to iron out language that both sides could accept...

Dr. Michael Givel of the Department of Political Science at the University of Oklahoma, in a July 2007 editorial about FDA legislation published in the of the international medical journal Tobacco Control also mentioned how the negotiations were carried on in secret:

The beginning of this highly unusual effort by Philip Morris [to implement its FDA policy goals] began in November 2001 when secret negotiations, of which many public health advocates were unaware, were initiated between Philip Morris and the Campaign for Tobacco-Free Kids.

That the current FDA bill was created through secret negotiations apparently orchestrated by PM certainly seems to be the case. No other public health entities with exceptional experience in tobacco control were asked to participate in formulating the proposed regulations -- no current or former Surgeons General, no one from the American Association of Public Health Physicians, none of the many prominent longtime public health advocates around the country with decades of experience fighting the tobacco industry, and no public health advocacy groups that have detailed knowledge of tobacco industry strategies or the best track records of success in reducing public smoking, like Americans for Nonsmokers Rights or the state Groups to Alleviate Smoking Pollution (GASPs). No scholars in tobacco industry documents or tobacco policy were invited. The amount of valuable tobacco control expertise and knowledge that was summarily excluded from the negotiations to create the bill is amazing -- and highly suspect.

CTFK ducked questions about the "secret negotiations" claims and instead steered us to "FDA" section of their Website and suggested we contact the Senate sponsors of the bill for comment. The American Cancer Society, which has been fighting tobacco for decades, declined to comment when asked how they felt about being excluded from the negotiations.

Worrisome as well is the fact that the tobacco industry has a long record of turning regulation and settlements to great advantage. As with the 1968 law mandating warning labels on packages, the 1971 law ending cigarette ads on TV, and the 1998 Master Settlement Agreement, over and over PM in particular has shown that it knows very well exactly what concessions can be made that will do little harm to tobacco companies while benefiting the industry in the long run.

Giving up TV advertising freed cigarette companies to spend more money on other beneficial and diverse forms of advertising and promotion, like ads in newspapers and magazines and on public transport. Agreeing to put "Surgeon General" warnings on packs handed cigarette companies a shield against liability, since then they could claim that after a certain date everyone had been warned of the hazards of smoking. In the 1998 Master Settlement Agreement, the industry gave up advertising on billboards, public transport and ads within a certain distance of schools, but then concentrated money on targeting young adults en masse through "bar nights," sponsorship of musical bands, and other novel promotions. By now we know that the elusiveness and creativity of tobacco companies is unparalleled; they simply cannot be expected to abide by the spirit of a law.

Who's Making the Big Concessions?

The currently-proposed FDA regulations may sound good to those not steeped in the tobacco industry's behavioral history or long-range strategies, but predictably, given PM's involvement in crafting it, the bill is riddled with loopholes that clearly will benefit the tobacco industry, and leave protection of public health in the dust.

The bill would assign the task of chemically modifying cigarettes to the FDA, which not only turns FDA into a de facto Research & Development arm of the tobacco industry, but virtually assures that only minor changes will take place in cigarettes, if at all, over a long period of time. After all, tobacco industry documents show that the industry itself has engaged in secret research to try to make cigarettes safer by removing specific chemicals from smoke. They never published the results of their research in peer-reviewed journals, so FDA likely cannot benefit from it. Evidently tobacco companies were not very successful in this endeavor, either, since over 400,000 people still die each year in the U.S. from using their products. So if the tobacco industry can't make cigarettes safer through chemical alteration, then how can FDA be expected to do it?

The proposed law also presents a bureaucratic and funding nightmare to FDA, an agency already heavily influenced by corporations and that already has a remarkably poor track record of protecting consumers. Under the bill, even the date that the legislation goes into effect must be timed to minimize economic loss to, or disruption of the cigarette trade -- another example of how the bill elevates the needs of tobacco companies above the need for effective and immediate action to reduce nicotine addiction.

CTFK and the other voluntary health groups supporting this bill -- American Lung Association and the American Heart Association -- need to answer the question, "How does passing legislation that is in the best financial interests of the largest, smartest and most aggressive tobacco company in the U.S. serve the public health agenda?" The answer is that it doesn't.

Looking at the whole picture, it appears that not only has the current FDA-Tobacco situation been engineered by Philip Morris in a far-reaching plan to enact its own preferred regulations while fracturing the cohesion of public health groups, but it seems that Congress accepts that it must kowtow to Philip Morris to get anything done.

A bill to regulate tobacco products needs to be crafted solely with public health in mind, and done in a way that assures that it will advantage no tobacco company over the long or short haul. It should implement a comprehensive strategy aimed at eventually winding down and ending commercialized nicotine addiction. In effect, such a bill should be an End-game strategy. The keys to what would be effective for this are contained in the industry's documents: simply look at what tobacco companies fight tooth and nail to avoid. At a minimum, legislators and voluntary health associations should work to enact measures that PM doesn't want, instead of measures it does want. Government shouldn't be in the business of advancing tobacco companies' best interests. The regulations that PM works behind the scenes to avoid are the ones that will truly benefit public health.

Comments

Anne - the best and clearest analysis I've seen on this. Many thanks. The objective of 'FDA regulation' has been a long standing call, but when you look at exactly what the FDA (or any regulator) can actually do - let alone will feel empowered to do or bold enough to do, it wont amount to much. It will tie up campaigning resources in the obscurities of smoke chemistry, additives, titration and the physics of irrelevant devices that will be used by virtually no-one, but will create the appearance of progress. Of course, the one big regulatory opportunity - in skewing the market towards non-combustible tobacco at the expense of cigarettes - is going to be squandered for inexplicable reason that no-one backing the bill can explain despite being repeatedly asked. I don't expect you'll get an answer to the questions you put. The organisations that you addressed them too are way to arrogant, mighty and unaccountable to bother with critics, however well informed. Clive

I'm not sure that regulations that PM wants to avoid will help public health as much as people wanting to quit smoking or choose not to smoke in the first place. Increasing taxes has not dramatically stopped smokers from smoking. In the states that began banning smoking in public places such as bars, clubs, restaurants the smokers just went outside and are fine with it. PM knows smoking is addicting and most regulations they help with certainly wont change the minds of all the smoking addicts out there. I used to smoke went cold turkey and haven't touched a cigarette since. How and why people choose to ignore smoking as an addiction is beyond me. I personally think more drug treatment centers should begin including cigarette addiction as part of their treatment programs the same as any of the other drug abuse problems they help people with every day. But when people are going to try and quit on their own then they go out have a drink and a cigarette or a friend had one so they did, how on earth can they attempt to quit when smokers are all around us all the time.

I strongly feel that the tobacco industry really needs to be dealt with severely and hope that PM really goes all the way in dealing with tobacco. "5) make cigarettes unpalatable or unaddictive, because then people would be able to more easily stop using them; " This one caught my eye. I can't believe that tobacco companies could get away with making cigarettes so addictive for so long. Also, another point I want to raise. It makes me angry that the more we stay away from smoking in the West, the more that these tobacco companies prey on third world countries who don't know the dangers of smoking. Tobacco companies are no better than drug dealers!

I always enjoy reading about public health twits lamenting about what they always say they want. Because in reality, the lives of these activists must be so low that they simply have try to control how other people want to live. Case in point: tobacco. In the 1960's the public health community insisted that tobacco companies come up with cigarettes with reduced tar and nicotine and create a testing method, administered by the government to prove that these cigarettes contained less tar and nicotine. 40 years later, these same activists came up with the argument that smokers actually compensate for the reduction in nicotine and tar by holding the cigarettes in such a way as to make them just as potent as so-called full-flavor (i.e. higher tar and nicotine) cigarettes. What are these public health dimwhits smoking? Have you ever seen anyone smoking a cigarette in some weird way where they actually squish the tube so that it can somehow create more tar and nicotine? It's assinine. When that wasn't good enough, it was time to simply discount the whole concept of light and ultra light cigarettes when any smoker can tell you that there really is a difference in the amount of tar and nicotine in a full-flavor cigarette vs. a light cigarette. Then of course, we have FDA regulation: When David Kessler wanted to circumvent the Food Drug and Cosmetics Act and simply assert jurisdiction over tobacco as a "drug delivery device," like a I.V. bottle or syringe, that was all well and good. When the tobacco industry actually approached Congress about creating a revision to the FDCA to include tobacco in a balanced approach that was BAAAAAAD. See, public health advocates would rather have tobacco users die of cancer than actually admit that people are going use tobacco products which should therefore be regulated by the government so that legitimately safer products are sold rather than the current variety. Then of course, we have the entire pharmaceutical industry that is making an absolute mint off of selling smoking cessation devises that of course are expensive and don't really work, so they want to perpetuate the status quo as well. And let's not forget the trial lawyers who have made billions suing tobacco companies because consumers chose to use a product that they knew what bad for them, were consistently warned about the health affects and then ultimately contracted diseases. So, yes, of course, let's maintain the status quo. And of course, it's far easier for a medical researcher to get a nice fat $50,000 grant out of federal and state health agencies to research the affects of tobacco "advertising" on kids (has anyone actually seen a tobacco ad recently, since the Master Settlement Agreement went into affect in 1998?), than it is for the a researcher to get a grant to study various potential cures for cancer itself. So plenty of researchers have gotten quite fat off of doing inane studies that try to predict just how many kids won't smoke if you raise the price of a pack of cigarettes to the same price as a used Volvo. This whole thing boils down to money and control. A bunch of lazy public health advocates, rather than letting people live their own lives their own way, want the government to tell people what to do and along the way, well of course it wouldn't hurt to have a little cash roll their way. Ask Stanton Glantz, or Dicky Daynard how much money they have made on this issue and they clam up. So of course, FDA regulation of tobacco was a bad idea. It upset the status quo of bitchers, whiners and carpet baggers.