The Cigarette Papers "d0e5938"

Tobacco Substitutes

In the late 1960s and early 1970s, many in the cigarette industry thought that the use of tobacco substitutes in cigarette blends would substantially reduce the toxicity of cigarettes. Consequently, various possible substitutes were tested for tobacco-like qualities on the one hand and for reduced toxicity—especially for reduced activity in mouse skin-painting experiments—on the other. Products containing tobacco substitutes were briefly marketed in Germany and in the UK, but they did not become established in either market.

Tobacco substitutes posed special problems for American cigarette companies because of the legal environment in the United States. Putting nontobacco material into the blend as a tobacco substitute would likely have raised a variety of awkward questions in the United States. To the extent that the substitute material replaced tobacco in a cigarette, the product would be less a tobacco product and more a drug, an article intended to prevent disease. This substitution, in turn, would have raised the risk of FDA scrutiny and would have drawn the attention of attorneys specializing in products liability matters.

On October 22, 1973, William Shinn of Shook, Hardy & Bacon sent the general counsel of B&W, DeBaun Bryant, a copy of a June 2, 1973, editorial from Lancet , a British medical journal {1124.05}, concerning a tobacco substitute that had been developed {1124.04}. The editorial described New Smoking Material (NSM), a product developed in Britain by Imperial Tobacco Ltd. (ITL) and Imperial Chemical Industries, Ltd. (ICI), as a less toxic, wood pulp–based, tobacco substitute for cigarettes.

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ITL research, as reported in this editorial, had shown that NSM "is less irritant to animal tissues and less carcinogenic for the skin of mice." ITL and ICI were building a factory to manufacture NSM, and the editorial writer speculated that if a government committee found NSM less hazardous than tobacco, the material might one day entirely replace tobacco in cigarettes. While the editorial recognized the importance of nicotine for the appeal of smoking, it did not point out the necessity of adding nicotine to an all-NSM cigarette.

Shinn may have sent Bryant the editorial in anticipation of a meeting between Ed Finch, B&W's CEO, and Malcolm Anson, ITL's CEO, in Louisville in the first week of November. Anson also met with the general counsel for B&W and the company's director of research. Following his return to Bristol, Anson wrote Finch a letter commenting on the concerns expressed by the B&W executives about substitute smoking materials.

You and your colleagues gave me some fairly unmistakeable messages on the subject of substitute smoking materials, and on the more general political and scientific aspects of the smoking and health question. This did not entirely surprise me because I know that American manufacturers approach this matter from a different legal and philosophical background, but it was very helpful to me to be exposed to the arguments at first hand, and I now have a much more vivid picture of the considerations which are upper most in your minds when these issues are raised. This is extremely helpful and I very much hope that we shall continue this kind of dialogue at regular intervals.

I particularly noted the reservations which you expressed concerning the National Cancer Institute [NCI]. I entirely understand your desire for us to be discreet but equally as I explained we shall not wish to forego making what capital we can out of any pronouncements which NCI may produce. {1124.01, pp. 1–2}

While ITL and its competitors did not put cigarettes containing tobacco substitutes on the market until 1977 (awaiting an official blessing of the British government through its Hunter Commission), Courtaulds, a small domestic British tobacco company, jumped the gun by test-marketing a brand called Planet in November 1973. The launch was greeted with substantial criticism in the press questioning whether Planet was "safer" and asking "safer than what?" {1124.03}. The criticism illuminated the potential difficulties that would confront the industry in trying to introduce a "safer" cigarette. The industry's interest is documented in a packet of press clippings {1124.03} that G. C. Hargrove of BAT's Millbank office sent to the CEOs of BAT subsidiaries around the world on November 8, two days after the introduction of Planet {1124.02}.

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The BAT R&D conference at Duck Key, Florida, two months later (January 1974) shed additional light on the thinking within the company about tobacco substitutes. The first conclusions of the conference involved the substitutes.

1.	The decision that B-A.T. would not use non-tobacco materials without a demonstrable advantage on health grounds has proved particularly effective in influencing Amcel [the maker of a tobacco substitute] developments—and since I.T.L. at that time concurred, probably in influencing the development of N.S.M. The interpretation by R. & D. of "demonstrable advantage" was a reduction in specific activity for smoke or condensate by most or all relevant biological tests available. It is now recognised that the development of the non-tobacco materials and their possible "acceptance" by medical authorities may change the position. Also the non-tobacco materials may become commercially very attractive on supply and price grounds.
	It is therefore now proposed that, although reduction in specific activity across the board would be most attractive and reduction in specific activity on key tests desirable, in the absence of significant behavioural differences, reduction in activity per cigarette (in all relevant tests) should now be accepted as sufficient for alternative smoking materials, both tobacco and non-tobacco.
2.	New smoking materials now under development include N.S.M., Cytrel, N.C.F. (Batflake and B. & W. version), Ecusta, Sutton Research, Reemtsma (BASF), Gallahers, Rothmans, Brinkmann and Courtaulds. No information is available on Reynolds and Philip Morris in this field. The front runners are N.S.M., Cytrel, Courtaulds, with Batflake having advantages for taste and cost. Since Courtaulds material is being tested biologically, they appear to have failed so far to make a good cigarette and yet could be on big scale production before any others; B-A.T. should talk to Courtaulds if this can be arranged ...
3.	American Celanese have informed us that the proposed short tests by the Hunter Committee are sebaceous gland, hyperplasia, rat trachea, lung cell activity, macrophage, ciliastasis, mytochondria, mutagenicity, teratology and Goblet cell. Long term tests are mouse skin, rat inhalation, and possibly dog inhalation. It will be interesting (possibly alarming) if this list proves correct when Hunter outlines his proposals to the U.K. industry for the first time on February 8th.
	Estimated cost to cover [test and bring to market?] four Cytel 324 and 361 variants is over $1 million p.a. [per annum] for 5 years. {1125.01, pp. 1–2}

In early 1974, then, tobacco substitutes played a substantial role in BAT's R&D effort, and there was at least some sharing of information among a variety of companies outside of the United States. Reduced toxicity, as measured in a variety of short- and long-term tests, was the goal. While the UK government–sponsored Hunter Committee might insist on a large battery of tests, at the least, BAT agreed with the principle that

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the value of a tobacco substitute was primarily its lower toxicity in such tests in comparison to tobacco itself.

A glimpse at BAT's internal R&D effort for its own version of a tobacco substitute, Batflake, is contained in the summary of a Southampton research report {1127.01}. The document, dated July 2, 1975, relates preliminary results of inhalation toxicology testing of cigarettes containing various proportions of Batflake Mark II compared to British-style cigarettes containing 100 percent flue-cured tobacco.

The study reported here involved preliminary range finding work to fix exposure conditions, a dosimetry experiment, measurements of respiratory function of animals and an extensive pathological examination, particularly of the respiratory system. {1127.01, p. 1}

The report indicates that the exposure system actually delivered cigarette smoke to "all parts of the respiratory system" of the rats and was similar for all the experimental cigarettes. Nasal filtration, often considered an obstacle in rodent experiments, "did not occur to a very significant extent" {1127.01, p. 1}. Carbon monoxide levels were similar in all groups. Smoke exposure led to reduced body weight and to an increase in the weight of heart, lung, and trachea. Lung and trachea weight increase was inversely related to the proportion of Batflake in the cigarette; Batflake also provided some protection against increases in heart weight.

Most rats survived to termination and the inhaled smoke caused:

1.	Squamous metaplasia in the larynx.
2.	Hyperplasia and keratinisation in the larynx.
3.	Goblet cell hyperplasia in the bronchi.
4.	Goblet cell hyperplasia in the nasal cavity.
5.	Increased macrophage activity in the lung. {1127.01, p. 2}

The presence of Batflake in the cigarette reduced the degree of effects 2, 3, and 5 in proportion to the amount of Batflake added. However, squamous metaplasia of the larynx was seen in every rat exposed to smoke, regardless of the proportion of Batflake in the cigarettes. So, by mid-1975 BAT had evidence from its own laboratory that cigarettes made with Batflake as part of the blend were less toxic than conventional cigarettes.

The Hunter Committee, chaired by Professor (later Lord) Robert Hunter, advised the Secretary of State in the United Kingdom on tobacco issues. In particular, its focus was on tobacco product testing and on research on less hazardous smoking. In 1975 the committee gave tobacco substitutes a lukewarm, preliminary endorsement:

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The product may be no more dangerous to health than a similar product containing tobacco only and could prove to be less injurious. (18, pp. 95–96)

In July 1977 Imperial, Gallahers, and Rothmans (other competing British tobacco companies) launched a dozen versions of cigarettes made with tobacco substitutes, either NSM or Cytrel. Health groups and the Minister for Health criticized these products as unsafe because they still delivered substantial doses of toxins. Their sales were minuscule—in part because the public health community criticized them as unproven half measures—and they were withdrawn within a few months (18).

So, in the end, the concerns at B&W about the risks posed by tobacco substitutes were much ado about nothing. However, the episode illustrates the company's fear that steps taken publicly to make cigarettes safer would expose the harmfulness of the basic product and therefore constituted a great risk. The tobacco substitute story also illustrates the fact that the essential ingredient in tobacco products is not tobacco: It is nicotine.