Ashes to Ashes (145 page)

To base the policing powers of the FDA on manufacturers’ stated intentions in marketing a product instead of on its measurable effects on customers’ health was absurd on its face. By the same logic, the state ought to have been denied the right to press charges against a drunk driver who ran over a pedestrian or against a robber who killed a store clerk, because neither of them had intended to take a life. Forty years of scientific investigation had documented the systemic pathological impact of smoking on the “structure and function of the body,” regardless of the cigarette manufacturers’ avidly advertised intention to provide pleasure only—pain was never mentioned. Yet historically the FDA itself insisted that the agency had no power to intervene so long as the cigarette companies made no explicit health claims.

No way out of this legalistic bind was formulated until 1988, when Matthew Myers of the Coalition on Smoking or Health filed a pair of petitions with the FDA urging it to regulate all low-tar cigarettes as well as the new Reynolds “smokeless” brand, Premier, on the premise that these modified products were clearly
intended
to mitigate or prevent disease formation, as 1935 Senate committee language required. The Coalition’s argument was not easy to ignore, for in marketing lower-yielding cigarettes—and, indeed, all filter-tip brands—by manufacturing innovations for more than a third of a century, the tobacco industry could have had but two purposes: (1) to respond to health
charges, essentially dose-related, by reducing the toxicity and widely reported pathological effects from the use of their product, or (2) to satisfy consumers’ perception that purposely weakened cigarettes were less hazardous—or might well be, as Rose Cipollone had testified to be her belief when switching to lighter brands. It was a distinction without a difference; either way, the manufacturers’
intention
was to market a product that did in fact, or appeared to, mitigate or prevent disease and thus qualified under law as suitable for FDA regulation.

But the Coalition petitions were left on the table as the FDA stalled, partly because, as a dependency of the HHS Department, rather than an independent agency like the FTC or FCC, it was beholden to the antiregulatory policies of the Reagan-Bush White House, and partly because, if the Coalition’s logic was applied closely, only low-tar, filtered, and otherwise modified forms of cigarettes would qualify for FDA regulation while the old, filterless, and unaltered high-yielding brands might escape the regulatory net. Thus, the question stood on hold in 1990 when Bush appointed thirty-nine-year-old pediatrician David A. Kessler, a newcomer to government bureaucracy, to administer the FDA as its one-man commissioner. He was an odd choice for a President who had been a paragon of passivity in addressing the social ills and health needs of the nation.

A Phi Beta Kappa graduate of Amherst, with a medical degree from Harvard and a law degree from the University of Chicago, the bearded, brilliant Kessler had served six years as hospital administrator at New York’s Albert Einstein College of Medicine before being tapped for the top FDA post. Reputedly instilled with high scruples and a sincerity that political infighting was sure to challenge, Kessler inherited an understaffed and underfunded agency charged with regulating products that registered a trillion dollars in sales annually. Hopelessly backlogged with applications for approval of new drugs and devices, the FDA had lately been further demoralized by a scandal over lax oversight of generic drugs. Kessler shortly showed that the FDA might no longer be a toothless tiger when he made an example of Procter & Gamble by fining it for selling orange juice labeled “fresh” when it was in fact made from concentrate; he then banned nearly all breast implants as a health hazard and began to implement a new and complex set of food labeling regulations. There was too much else on his plate for Kessler to address the cigarette question, which, at any rate, was hardly a priority with the Bush people.

But the new, young commissioner assigned several dozen scientists, lawyers, and other agency staffers to look into the FDA’s power to regulate tobacco products, and cigarettes in particular as a drug-delivery system, even if the manufacturers did not admit that was their intention. The subject, though under continuing scrutiny, was left on hold until a new—and antismoking—president took over.

When Kessler finally felt it was timely to act, his tactic was fresh but the claim of its sudden availability as a weapon was in effect a shrewd contrivance. Instead of worrying about the entire product, the FDA commissioner dwelled on the known habituating effects of its chief druglike ingredient, nicotine, which, in turn, allowed the long-term pathological effects of smoking to develop. In a February 25, 1994, letter to Scott Ballin, by then chairman of the Coalition on Smoking or Health, Kessler asserted, “Evidence brought to our attention is accumulating that suggests that cigarette manufacturers may intend that their products contain nicotine to satisfy an addiction on the part of some of their customers,” and it was the FDA’s further understanding that the companies “commonly add nicotine to cigarettes to deliver specific amounts of nicotine.” If his agency made a finding to this effect and could prove it in court, “it would have a legal basis on which to regulate these products. …”

That nicotine was the ingredient in tobacco that induced a habitual craving for, dependency upon, or addiction to smoking cigarettes—call it what you will—had been common scientific knowledge for much of the twentieth century. That manufacturers had been controlling or manipulating the amount of nicotine their customers ordinarily derived from their cigarettes had been known for forty years, ever since the introduction of filter tips, to students of the subject, and to any portion of the public that thought for a moment about it. Independent tests run by Consumers Union and
Reader’s Digest
starting in the 1950s had revealed the variations in tar and nicotine yields by brands—surely not random or accidental but the result of technological advances by their makers. From 1967, the FTC had tested and regularly reported on these varying yields, and since 1971, every cigarette advertisement had been required to disclose the nicotine and tar yields of its brand. Plainly, the manufacturers had
intended
to vary the delivery levels of nicotine, with its body-altering effects, and on this premise, the FDA could at any time in the preceding generation have claimed that cigarettes were a drug as statutorily defined and gone to court to defend the agency’s right to regulate it. But it would have needed a determined commissioner, ready to confront a powerful industry with die-hard support in Congress, and a President likewise committed. And there had been neither until now.

On February 28 and March 7, just after Kessler went public with his nicotine stratagem, the ABC News television program “Day One” presented what it called the tobacco industry’s “last best secret … never before disclosed to consumers or the government”—that manufacturers were “spiking” or “fortifying” their cigarettes with extraneous nicotine for the express purpose of keeping their customers hooked. The closest the ABC programs came to documenting the spiking charge was an on-camera interview with an unidentified (and unidentifiable) former RJR manager, who said, “They [Reynolds] put
nicotine in the form of tobacco extract into a product to keep the consumer happy.” The clear implication was that this nicotine dosage exceeded what came naturally in the tobacco plant and that this seemingly sinister power to control the nicotine content was immoral if not downright criminal. Nowhere was a hint given that various strains of tobacco and indeed different leaves from the same plant, depending on their location on the stalk, naturally contained different amounts of nicotine and had long been blended by the manufacturers to vary the nicotine level—or that the artificial and mechanical means of lowering that level had been no secret for decades. Instead, “Day One” put on skilled smoking control advocate Clifford E. Douglas, then an ACS lobbyist, who said, “The public doesn’t know the industry manipulates nicotine—takes it out, puts it back in, and uses it as if it were sugar being put in candy. They don’t have a clue.” Clues, though, they had aplenty, unless smokers elected to believe that the wide variance in reported and advertised nicotine levels was merely one of Mother Nature’s dubious little gifts to mankind. The only legitimate question, really, was whether the tobacco companies were turning out
unnaturally
nicotinized cigarettes—juiced up, that is, beyond what grew in the fields,
even if
the government-tested yields had long been reported to the public.

To justify their assertions that the industry was or might be spiking cigarettes, ABC and the FDA pointed to the companies’ use of reconstituted tobacco leaf (RL), developed more than forty years before, long disclosed in books and articles, and described in the 1979 Surgeon General’s report. RL was salvaged as an economy measure from stems, lower in nicotine than the leaves, and scraps that had broken off during curing and were reconfigured in paperlike sheets that, after shredding, composed about one-third of the modern cigarette. During the RL process, solubles including nicotine were extracted from the mostly cellulose fibrous parts of the leaf; the nicotine was then returned to the reconstituted leaf along with some flavorings, preservatives, and a moisturizing agent. But according to one company, Philip Morris, which quickly filed a $10 billion defamation suit against ABC, “no nicotine whatsoever not found in the original natural tobacco materials is introduced in the production of reconstituted tobacco sheets,” which “contain approximately 20 to 25 percent less nicotine” than the natural materials because of what was lost during the extraction process “and is not replaced” (underscoring in the original text). The company’s complaint added flatly, “Philip Morris never had, and does not now add, any nicotine whatsoever in the process of manufacturing cigarettes. To claim that these processes constitute ‘spiking’ or ‘fortifying’ of cigarettes with nicotine to ‘hook’ smokers, to ‘keep people smoking’ is an egregious falsehood. To the contrary … the only adjustment of the nicotine content of cigarettes that is involved in the manufacturing process is the
reduction
of nicotine levels” (emphasis in original). Would it have been justifiable to claim that a dairy company was spiking natural milk with fat because it knew how to process skim or 1 percent milk but did not limit its output to those reduced fat varieties, a PM publicist asked as the suit against ABC neared the trial stage. It was a persuasive argument, which, coupled with the absence of hard evidence that the manufacturers were juicing up the product beyond what nature wrought—except by genetic experiments to develop nicotine-rich strains of tobacco leaf, often with help by Department of Agriculture scientists (the resulting yields of which, at any rate, were reported by FTC testing and not hidden from the public)—caused the TV network to recant in August 1995 with two on-air apologies and pick up PM’s legal expenses to get it to drop its slander suit. That ABC’s parent, Capital Cities, was about to be acquired by the Disney organization to form the world’s largest entertainment conglomerate no doubt helped speed the settlement.

The “spiking” charge might have carried more weight if it had been informed by disclosures just two months after the ABC-PM settlement by
The Wall Street Journal
, in a page-one October 18, 1995, report based on Brown & Williamson documents it had received from whistle blowers. These claimed that Philip Morris’s, and particularly Marlboro’s, dominance in the cigarette business stemmed in large part from the skillful admixture of ammonia compounds to its tobacco that served to intensify the potency of the nicotine in its brands without measurably increasing the quantity. According to a 1991 B&W “handbook” for its leaf blenders and product developers and a second analysis a year later on Marlboro’s runaway success, the additions of ammonia, a substance occurring naturally in tobacco, served as an “impact provider” by quickening the rate at which nicotine was absorbed in smokers’ systems—a finding corroborated, according to the
Journal
, by a number of top non-industry pharmacologists who contended that the quicker the nicotine absorption, the more satisfying and reinforcing its psychological (and, by extension, its addicting) effect. Other cigarette makers were also said to have adopted the practice.

In response to the
Journal
disclosures, tobacco company officials denied that the ammonia additives, which they readily acknowledged, were intended to increase the
amount
of nicotine smokers absorbed—but that had not been the charge, of course. PM scientists said the main value of the ammonia added was to keep the reconstituted leaf in its brands’ blends from falling apart by generating the release of gluelike pectins. Reynolds spokesmen said their primary task in developing cigarettes was “to sell sensory impact,” not addiction, as the public-health community was now charging, and the ammonia additives helped RJR brands to “smoke smoother.” But a former associate director of the Council for Tobacco Research, John Kreisher, may have come much closer to the truth when he remarked to the
Journal
, “Ammonia helped the industry
lower the tar and allowed smokers to get more bang with less nicotine. It solved a couple of problems at the same time.”

Thus, the industry may not have been precisely “spiking” the tobacco in its cigarettes with more nicotine, but it may well have been performing prodigies of chemical engineering to reduce the carcinogenic potency of cigarette smoke (i.e., through lowered tar yields) without comparably modifying its addicting properties, as the reduced nicotine yields measured by FTC-approved smoking machines plainly implied. In short, this would not have been an entirely good-faith effort by the cigarette makers to modify their product. Even if the newly revealed B&W documents were creditable, though, no one was saying just how much more potent the ammonia made the nicotine, probably because the impact was largely subjective and possibly beyond the reach of scientific calibration.