By Clifford E. Douglas
Posted: Friday, April 1, 1994
ARTICLES
Publication Date: April 1, 1994
Introduction
On February 28, 1994, Day One, a magazine show produced by ABC News, aired an expose on the tobacco industry's manipulation of nicotine. The segment (and a follow-up segment which aired on March 7, 1994) resulted from a year-long investigation by Pulitzer Prize-winning journalist Walt Bogdanich, a Day One producer and former Wall Street Journal reporter, and associate producer Keith Summa. The imminent airing of the first segment on a Monday prompted the release the preceding Friday of a remarkable letter by Food and Drug Administration (FDA) Commissioner David Kessler, announcing that in light of the new evidence the FDA would consider regulating tobacco products as drugs. While the FDA reportedly had been interested for some time in pursuing regulatory action against tobacco products, the information obtained by Day One provided the "hook" the FDA felt it needed in order to proceed.
The Day One story and the FDA's own findings illustrate publicly for the first time the extent to which the tobacco industry is capable of and does in fact manipulate the amount and even the presence of nicotine in cigarettes. Before these recent revelations, nicotine generally was perceived to be merely a natural part of the tobacco leaf and an inevitable component of any tobacco product. The potential implication of the new disclosures is substantial.
Background
The presence of nicotine in tobacco products makes them addictive and is the reason many people smoke despite the evidence of the harmful effect of tobacco use.
Nicotine appears naturally in tobacco and is absorbed into the body when tobacco is smoked, chewed or sniffed. Nicotine has always been perceived as an inevitable part of the tobacco leaf. "If you used tobacco, you ingested nicotine."
The role of nicotine in tobacco products has been studied for years. In the early 1980's, a scientific consensus developed that cigarettes are not just habit-forming but addictive in the same way that drugs such as cocaine and heroin are. This research resulted in an entire report by the U.S. Surgeon General devoted to the addictive nature of tobacco products and the central role that nicotine plays in causing that addiction. The release of the 1988 Surgeon General's report silenced any lingering, credible scientific debate about whether tobacco products are addictive and whether nicotine is the substance in tobacco products that makes them addictive. The latest Surgeon General's report on children and tobacco, issued on February 24, 1994, confirmed that the nicotine in tobacco products is responsible for the rapid addiction of up to half of all children who experiment with tobacco.
The FDA regulates nicotine when included in other products but has not regulated it in tobacco products (Favor, a nicotine delivery system produced by Advanced Tobacco Products, was an exception to this rule. It was regulated by the FDA on the basis of its nicotine content).
Federal law gives the FDA regulatory authority over food, drugs and cosmetics. Certainly, tobacco products (cigarettes, chewing tobacco and snuff) are not considered foods. Neither are they drugs as defined by the FDA. To conclude that a product is a drug, the FDA has held that a the product must not only affect the structure and function of the body; in additon, the seller (manufacturer) must intend it to do so. Thus, the FDA has determined that cigarettes which are advertised and sold "for smoking pleasure only" are not drugs.
Even so, the FDA has long recognized nicotine as both an addictive and toxic substance. As a result, the FDA tightly regulates the sale and use of nicotine in all forms and in all products (i.e., nicotine gum or nicotine patches) except when sold for "pleasure" as part of a tobacco product. Until now, the FDA's rationale for not regulating nicotine when sold as part of a tobacco product has been that there is inadequate evidence that nicotine in tobacco products is sold with the intent tohave a pharmacologic effect on the body.
The tobacco industry knows that nicotine is addictive.
Internal tobacco industry documents made public during the trial in Cipollone v. Liggett in the 1980's demonstrate the industry's understanding of the central role that nicotine plays in causing and sustaining addiction. For example, an internal report written in 1972 by William L. Dunn, Jr., a senior scientist with the Philip Morris Tobacco Company, says the following:
"As with eating and copulating, so it is with smoking. The physiological effect serves as the primary incentive; all other incentives are secondary.... Without nicotine, the argument goes, there would be no smoking. Some strong evidence can be marshaled to support this argument: (1) No one has ever become a cigarette smoker by smoking cigarettes without nicotine. (2) Most of the physiological responses to inhaled smoke have been shown to be nicotine-related.
"Why then is there not a market for nicotine per se, to be eaten, sucked, drunk, injected, inserted or inhaled as a pure aerosol? The answer, and I feel quite strongly about this, is that the cigarette is in fact among the most awe-inspiring examples of the ingenuity of man....
"The cigarette should be conceived not as a product but as a package. The product is nicotine. The cigarette is but one of many package layers. There is the carton, which contains the pack, which contains the cigarette, which contains the smoke. The smoke is the final package. The smoker must strip off all these package layers to get to that which he seeks....
"Think of the cigarette pack as a storage container for [a] day's supply of nicotine.... Think of the cigarette as a dispenser for a dose unit of nicotine.... Think of a puff of smoke as the vehicle of nicotine.... Smoke is beyond question the most optimized vehicle of nicotine and the cigarette the most optimized dispenser of smoke."
Moreover, it was not disclosed until March 1994 that Philip Morris Inc.'s own researchers prepared a paper in 1983—five years before the Surgeon General's landmark report on addiction — reporting that nicotine had been found to be highly addictive in rats. The report was peer reviewed and accepted for publication in a respected scientific publication, Psychopharmacology, but then withdrawn on the company's orders. Subsequently, Philip Morris closed the researchers' laboratory.
Despite the evidence of the addictive nature of tobacco and the tobacco industry's awareness of the role of nicotine, neither Congress nor the FDA have yet altered their traditional hands-off role towards regulating tobacco. This may soon change, however, in light of the new evidence. The FDA is considering its options, and Congress is holding hearings and starting to address these issues.
More on the Nature and Extent to Which Tobacco Manufacturers Manipulate Nicotine
While it has been known for some time that tobacco manufacturers have some control over nicotine, new evidence shows that:
* Tobacco manufacturers have the capability to remove all or virtually all of the nicotine from their tobacco products using technology already in existence.
* They currently remove substantial quantities of the nicotine from tobacco, manipulate the extracted nicotine and then apply it to the final manufactured product in carefully controlled, precisely measured quantities. According to sources from within the tobacco industry and independent researchers who have analyzed the contents of leading cigarette brands, as much as 40 percent or more of the nicotine contained in some cigarettes is nicotine previously extracted from tobacco, manipulated and reapplied. A lawyer for R.J. Reynolds (RJR) testified before Congress that approximately 70 percent of the nicotine contained in the company's ill-fated nicotine delivery device, Premier (which some observers inaccurately dubbed a "smokeless cigarette"), consisted of separately added nicotine extract. In addition, information indicates that at least two major cigarette companies are using virtually pure liquid nicotine as an additive in the production of new cigarette products not yet on the market. These contain little if any nicotine other than that which has been added.
* Tobacco manufacturers add substantial quantities of nicotine to their products that they have purchased from other sources, including firms which specialize in extracting and processing nicotine. Firsthand witnesses have described large stainless steel vats containing ill-smelling, highly toxic liquid nicotine in warehouse-size rooms at tobacco manufacturing plants.
In a nutshell, what this means is that while nicotine appears naturally in raw tobacco, it is no longer an unavoidable component of a cigarette product. Today, tobacco manufacturers consciously manipulate nicotine during the manufacturing process. They add nicotine to the processed tobacco and other contents of the manufactured product.
While manufacturers have used a number of euphemisms to describe the role of nicotine, there is widespread agreement in the medical and scientific communities that its primary function is to make the product addictive.
The Tobacco Reconstitution Process
It has long been known that tobacco manufacturers prepare a substantial portion of the contents of their cigarettes through what is called the "reconstitution" process. What has not been known is the extent to which manufacturers could remove all or virtually all of the nicotine and the fact that in some cases the manufacturers are boosting the quantity of nicotine found in the reconstituted tobacco beyond the level which would otherwise be found there.
One reason why tobacco manufacturers use nicotine extracted from tobacco is that in its natural state, the nicotine in the tobacco leaf is distributed in uneven concentrations. By extracting the moisture from tobacco, including nicotine, manipulating it and spraying the extract evenly across the reconstituted tobacco sheet, manufacturers are able to control the precise amount of nicotine and provide a smoother, more consistent drug delivery per puff. This process also saves manufacturers money, in part because it enables them to use substantial amounts of reconstituted tobacco (consisting of tobacco leaf scraps and stems, dry tobacco dust, adhesive, reinforcing fibers, mineral ash modifiers, humectants and other inexpensive material) and less actual tobacco, which is the most expensive part of the cigarette.
LTR Industries, a subsidiary of Kimberly-Clark Corporation, specializes in the tobacco reconstitution process and, as the company says, in helping tobacco companies control their nicotine. The LTR reconstitution process is used around the world. An LTR advertisement published in tobacco industry trade publications states:
"Nicotine levels are becoming a growing concern to the designers of modern cigarettes, particularly those with lower 'tar' deliveries. The Kimberly-Clark tobacco reconstitution process used by LTR INDUSTRIES permits adjustments of nicotine to your exact requirements. These adjustments will not affect the other important properties of customized reconstituted tobacco produced at LTR INDUSTRIES: low tar delivery, high filling power, high yield and the flexibility to convey organoleptic modifications. We can help you control your tobacco." (Emphasis added.)
This process is also described in the tobacco industry's own trade literature, which explains that LTR's process enables manufacturers to triple or even quadruple the nicotine content of reconstituted tobacco, thus substantially increasing the level of nicotine contained in the final manufactured product. In addition, tobacco industry patents, cited by FDA Commissioner David Kessler in testimony before Congress, describe the manipulation of nicotine in tobacco products.
What Policy Options Are Now Available?
The new information about the tobacco industry's nicotine manipulation yields several options. One focuses on the amount of nicotine in tobacco products. Given that the technology exists, it is possible to order, at the state or federal levels, that nicotine in tobacco products be reduced to non-addictive levels or eliminated entirely. Eliminating or restricting the use of nicotine in tobacco products is the most intriguing proposal. This option presents the greatest opportunity for influencing consumption directly. An unresolved question is precisely how much nicotine is necessary for a product to be addictive. What is known is that it is a very small amount.
A second option focuses on potential regulations that restrict the advertising, marketing and manufacture of tobacco products which contain nicotine, such as those proposed in federal bill H.R. 2147 introduced in the 103rd Congress by Rep. Mike Synar (D-OK). The FDA controls what additives may be placed in products that it regulates. The agency also maintains control over the advertising and promotion of those products and, for some, restricts where and to whom the products can be sold. Applying similar rules to tobacco could foster meaningful restrictions that would make it more difficult for minors to purchase these products.
Another option would be for Congress to legislate differential tax rates on tobacco products based on their nicotine content, thus effectively making tobacco products with addictive levels of nicotine more expensive and thus less accessible to children and teenagers. This option would have to be considered quite carefully, since, as noted, even very small quantities of nicotine make a product addictive.
If the FDA determined that the new information is adequate to take jurisdiction over tobacco products as "drugs," it could take a number of actions under its existing authority. While one might assume the FDA will have to assert jurisdiction in light of the new information, actually, the FDA has substantial discretion in whether to exert regulatory authority. In the late 1980's, the FDA failed to act on a petition filed with the agency by health groups calling for regulation of RJR's "Premier," despite the knowledge that nicotine was intentionally added to the non-tobacco portion of the product. Now, however, the letter issued by the FDA's Commissioner Kessler on February 25, 1994, and his subsequent testimony before Congress, signal that the agency is seriously rethinking its stance.
If the FDA nonetheless fails to take sufficient action, Congress could either give the FDA specific authority to act or could itself enact legislation governing the nicotine content of tobacco products, restricting tobacco marketing, etc. In addition, state agencies with regulatory authority similar to that of the FDA could act for their own particular states. Petitions similar to those filed with the FDA also were filed with a number of state food and drug agencies before the revelations regarding nicotine manipulation became public. No action has been taken on any of them. Health groups could now supplement these petitions with the new information or submit new petitions dealing specifically with the need to regulate nicotine in tobacco products.
Litigation Potential
Knowledge of the tobacco manufacturers' deliberate manipulation of nicotine has the potential to change dramatically the product liability scene as it affects smoker death lawsuits.
A number of state laws exempt the manufacturers of those products which are considered to be "inherently dangerous" from product liability. These laws have shielded tobacco manufacturers from liability in a number of cases involving tobacco-related deaths.
Since the new information makes clear that nicotine is not an inherent and unavoidable part of tobacco products, plaintiffs may now be able to argue that the laws preempting litigation involving inherently dangerous products should not shield tobacco manufacturers. Plaintiffs might argue that tobacco products are "inherently dangerous" only if their addictiveness is inherent. The news of industry manipulation suggests that this is not the case. Even if they want to quit, many smokers can't because of their addiction. Hence they continue to be exposed to the numerous carcinogens and other toxins present in tobacco and tobacco smoke. If a plaintiff can demonstrate that he or she became addicted to tobacco products because of the deliberate manipulations of the manufacturer, the manufacturer's defense would be severely weakened.
This cutting-edge legal argument involving nicotine and addiction could thus provide plaintiffs with a tool to overcome some of the existing exemptions in state product liability laws. Four additional legal possibilities suggested by the Tobacco Products Liability Project may also thwart tobacco company defenses.
"Many states hold manufacturers "strictly liable" only for those 'unreasonably dangerous' products for which a safer feasible alternative existed. This limitation, strongly supported by the tobacco industry, was generally supposed to protect it from strict liability. The new revelations suggest that the tobacco industry has known how to make safer cigarettes, but has deliberately made them more addictive to increase their market appeal.
"Tobacco companies defend their products in court by arguing that the use of tobacco is a great American tradition, dating back to the Indians and the first settlers. But, since the Indians and the first settlers did not chemically remove nicotine from — and add nicotine to — their tobacco so as to maximize the customers' addictions, the new revelations may make it harder for tobacco defendants to win juror sympathies.
"Deliberately manipulating nicotine levels to hook their customers, and keep them hooked, is clearly an 'intentional tort.' Unlike negligent or even reckless behavior, intentionally tortious behavior is likely to alienate both judges and jurors, producing punitive damage verdicts which will be upheld on appeal.
"Civil RICO class actions by consumers seeking reimbursement of expenses for breaking their addiction, or even perhaps for servicing their addiction, may now be possible. They may now be seen as furthering a core function of the Racketeer Influenced and Corrupt Organizations Act — to redress financial injuries caused by the behavior of drug cartels!"
Epilogue
What would a society free of almost all tobacco product-related nicotine addiction look like? If the FDA and/or Congress mandate that tobacco manufacturers reduce the quantity of nicotine in tobacco products to non-addictive levels, some addiction experts predict that perhaps 95 percent of all smokers would successfully quit using tobacco in the long term. If we ignore for the moment, the possibility that a black market in nicotine-containing tobacco products might emerge which could influence the ultimate picture (although only in part), we can foresee 47 million of the 50 million people (including children) who currently smoke cigarettes in the United States quitting. Thus, among other potential benefits:
* The number of cigarettes smoked in the United States each year would drop from roughly 500 billion to perhaps 25 billion.
* Since cigarette smoking is directly responsible for the premature deaths of approximately one of every four smokers, at least ten million lives would be saved among smokers now living, and countless additional lives would be protected in the future.
* Tobacco-related health care and economic costs would almost disappear in the long term. (They now exceed $68 billion a year.)
* Sickness and death related to secondhand smoke would be virtually eliminated.
* Injury, death and property damage resulting from cigarette-caused fires would quickly become a historical curiosity.
* More than 40 non-tobacco-producing states would benefit economically if tobacco sales were eliminated or curtailed, according to a recent study by economists at the University of Michigan. Expenditures on tobacco would be redirected into sales of other goods and services. While there would be small losses in retail and wholesale trade and in state and local government employment, there would be substantial gains in the remainder of the economy.
While such remarkable outcomes may boggle the mind, the possibility of accomplishing them has suddenly become real. The "outing" of the tobacco industry's manipulation of nicotine to addict millions has strengthened and emboldened an already thriving movement to control tobacco, protect children and save lives. Advocates, health minded policy-makers and others can take heart that the years of the modern epidemic of tobacco-related death and illness are now numbered — at least in the United States.
Food and Drug Administration and National Cancer Institute Statements on Nicotine Manipulation by Tobacco Companies
"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. The possible inference that cigarette vendors intend cigarettes to achieve drug effects in some smokers is based on mounting evidence we have received that: (1) the nicotine ingredient in cigarettes is a powerfully addictive agent and (2) cigarette vendors control the levels of nicotine that satisfy this addiction."
— Dr. David Kessler (February 25, 1994, letter to Coalition on Smoking OR Health
"The public knows that cigarettes are harmful and many smokers desire to quit. Research has revealed that 77 percent of smokers desire to quit but cannot primarily because of nicotine addiction."
— Dr. David Kessler (February 25, 1994, letter to Coalition on Smoking OR Health
"Although technology was developed years ago to remove nicotine from cigarettes and to control with precision the amount of nicotine in cigarettes, cigarettes are still marketed with levels of nicotine that are sufficient to produce and sustain addiction. In fact, it is our understanding that manufacturers commonly add nicotine to cigarettes to deliver specific amounts of nicotine"
— Dr. David Kessler (February 25, 1994, letter to Coalition on Smoking OR Health
"Cigarettes and other tobacco products have not been previously regulated except under rare circumstances. In effect, cigarettes have been nearly totally exempt from federal regulations which govern virtually all other consumer products in the marketplace."
— Samuel Broder, M.D., NCI Director (in NCI press release)
"Until now, cigarette manufacturers have been free to add virtually anything, in any quantity, to cigarettes and no regulatory mechanism existed which provided even minimal safeguards. Yet tobacco is the only consumer product on the market that when used as intended by the manufacturer, will kill 500,000 consumers this year."
— Samuel Broder, M.D., NCI Director (in NCI press release)
"The National Cancer Institute strongly supports the position of the U.S. Food and Drug Administration that nicotine is a drug and that tobacco products — like all drug delivery systems — could come under the same strict regulatory controls as nicotine drug products used in the management and treatment of cigarette addiction."
— National Cancer Institute press release, "NCI Supports FDA's Position on Nicotine and Cigarettes," 2/28/94
(From Priorities, Vol. 6, No. 2)
