Disclosure Of Additives

Since 1981 or even earlier, public health workers had been calling for legislation requiring that manufacturers specify the additives used in tobacco products. In 1984 they received a phantom of what they had

sought. Section 7 of the Comprehensive Smoking Education Act (Pub. L. 98-474), passed in 1984, included the requirement they had been seeking—namely, that manufacturers must disclose the additives to the Department of Health and Human Services—but added conditions that rendered the "disclosure" virtually worthless: the additives were to be shared only as an aggregate list, quantitative information was not required, and the information was to be treated as a "trade secret" and not disclosed to any unauthorized person. The veil of secrecy that this useless provision imposed was partially torn down in April 1994, when the cigarette manufacturers, under public pressure, voluntarily released an additives list. The B&W documents provide some background on the industry's attitude toward additives and their disclosure.

Lawyer Concerns Over Additives

From a legal standpoint, the tobacco industry has had good reason to be concerned about the potential hazards of additives. While it is one thing, in terms of products liability, to provide an essentially "natural" product to a consumer, it is quite another thing to alter that product by adding dangerous chemicals to it. For example, one might compare the difference between cigarettes without additives and those with additives to the difference between an apple that naturally contains arsenic in the core and an apple that has also been sprayed with DDT. The industry has generally defended products liability suits on an "assumption of risk" theory; that is, the smoker knew that cigarettes might be dangerous and assumed that risk in deciding to smoke. With the advent of the cigarette warning labels in 1965, this defense became even more formidable, because juries (who were unaware of the addictive nature of cigarettes) refused to believe that smokers did not know the risks they were encountering. However, those juries might have taken a different view if they had been told that the cigarettes smoked by the plaintiff were not merely made of cut, blended tobacco, but, in fact, contained numerous harmful additives that presented health dangers in and of themselves. There is also, when one considers potential health risks, a difference between an additive in its original state and an additive when burned in a cigarette. An additive that might be totally benign from a human health standpoint when in its original state might, nevertheless, be a serious health hazard when burned in a cigarette in combination with hundreds of other chemicals. Thus, even if the manufacturer of an additive had conducted sufficient testing to ensure its safety, a tobacco company us-

ing the additive in its cigarettes was still faced with the problem of determining the safety of the additive when burned in a cigarette.

Attorneys at B&W actively worked to keep abreast of the latest research dealing with cigarette additives. On December 26, 1978, Ernest Pepples sent a memo {1822.01} to Dr. J. G. Esterle, referring to an attached report (not in the documents) by the National Cancer Institute (NCI) on its bioassay of dl-Menthol for possible carcinogenicity and an attached list (also not in the documents) of chemicals being tested for carcinogenicity in the NCI program. Pepples asked, "When you have had a chance to look over the list please give me a call." Whether or not Esterle phoned Pepples, he did send him a reply memo on January 8, 1979, enclosing "a listing of chemicals which are included in the list of chemicals being tested for carcinogenicity in the NCI program and which are known or we consider likely to be present in cigarette additives" {1822.03}. Two days later, Pepples sent a letter to Fred Panzer at the Tobacco Institute asking him to "track" progress NCI had made in testing the very list of chemicals that Esterle had sent along to him {1822.02}. The list consisted of:

Chemicals Which Are Currently Used
     Benzyl acetate
     Cinnamaldehyde
     Eugenol
     D Limonene
     Safrole (mace)
     Titanium dioxide (filter tow, paper)

Chemicals Which May Be Present in Current Additives
     Allyl isovalerate
     Benzyl alcohol
     2,6 di t Butyl p cresol
     Cinnamyl Anthranilate
     Furfuryl alcohol
     Geranyl acetate
     Gums
     Isophorone
     a Methyl benzyl alcohol
     Propyl gallate
     Pyridine {1822.04}

Among the chemicals listed as being currently used, only cinnamaldehyde was named by the cigarette industry as an additive to

tobacco in 1994 (2). Titanium dioxide is still used as a whitening agent for cellulose acetate filter tow, but it is not added to tobacco.

B&W's Policy On Testing Additives

In 1967 Dr. R. B. Griffith, director of research at B&W, informed a group of USDA scientists and other officials that they must test combustion products of residues in tobacco to be assured of their safety {1302.01, p. 2}. By the 1980s this sensibility is no longer evident in the documents. Rather, concern about the toxicology of combustion products is termed "unscientific" and is projected onto critics and potential regulators.

Dr. J. G. Esterle, manager of smoking and health affairs at B&W, wrote a memo to Dr. R. A. Sanford, vice president for R&D, on September 11, 1981, about a "suggested program for testing biological activity of our cigarette additives" {1314.01}. The proposed program first takes note of B&W's additive policy and a criticism this policy has received.

B&W's policy on cigarette casing and flavoring ingredients is:

"To be used as a casing or flavoring in any of our cigarette products, an ingredient added to tobacco shall meet one of the following criteria:

Adherence to this policy provides B&W with a very favorable position in defense of our usage of flavors and casings. Yet, the regulatory and antismoking agencies have identified, at least from a PR standpoint, a weakness. This is that the additives are potentially altered during smoking which may provide a new health risk to the smoker. However unscientific this attack may be, we should be prepared to respond. The program, described here, is designed to provide that response [emphasis added]. {1314.02, p. 1}

These criteria permitted B&W to use any current additive, since only one of the criteria need be met and the first one essentially grandfathered all existing additives regardless of possible dangers. Moreover, the concerns expressed in the 1960s by a company scientist about the need to examine the combustion products of pesticides for toxicity are now instead attributed to outside, anti-tobacco critics.

The proposed solution was to conduct Ames testing of cigarette smoke from cigarettes, with the test additives added at ten to twenty times the

normal level {1314.02}. The Ames test is a test of mutagenicity which has been used as a screening test to predict carcinogenicity. Other screening tests were considered but discarded as inappropriate. The concern seems to have been focused exclusively on the possible carcinogenicity of pyrolysis products of additives. Esterle suggests that each flavor formula for each brand be systematically tested. The initial wave of testing was to be completed by July 1982. The tone of this proposal is purely defensive. The impression one gets is that the purpose of the test is not to determine whether there might be real problems but simply to obtain data that might be used if the company were forced to describe the toxicology of its additives in connection with a lawsuit or if the federal government were able to require the disclosure of additives.

Internal Debate Over Disclosure Of Additives

Two weeks after Esterle had formulated the defensive strategy for testing additives, J. K. Wells III, B&W's corporate counsel, wrote Pepples a "thinkpiece on the additives issue" {1316.01}. In his memo Wells summarizes discussions at a Committee of Counsel meeting held two days earlier. Representatives of B&W and five other companies attended the meeting and presented their views about disclosure of additives in the face of increasing pressure from the Department of Health and Human Services (HHS) and Congress. Wells describes the positions of the other five companies as follows:

RJR : Continue meetings with HHS at the industry's initiation and two or three meetings from now submit to HHS a list of commonly used casings and flavorings which would include about thirty items.

PM : Submit a list of about fifty items soon.

AMERICAN : Submit a list of the most heavily used casings and flavorings at any time.

LORILLARD : Stall any disclosure by industry as long as possible; industry should immediately appoint an independent panel of reputable toxicologists to review a list of as yet undetermined items.

L&M : Stall disclosure and industry should immediately appoint one independent toxicologist to review a list. {1316.01, p. 1}

Horace Kornegay of the Tobacco Institute indicated that the pressure from Congress was based on the industry's failure to disclose. Stanley Tempko, a lawyer at Covington and Burling, indicated that an industry-sponsored review panel would lack credibility.

The memo lists a series of pros and cons regarding disclosure. In favor of disclosure was the argument that there are no known toxicological problems, only "uncertainty," and that disclosure would solve the problem and reduce congressional criticism. Against disclosure was the argument that this is part of a long-term attack, that "anti-industry activists" would use such a list to their advantage, and that adverse scientific opinion would form around the list.

The pros and cons of an independent panel are also enumerated in the memo. The approach avoids legislation and mandatory disclosure while improving the public image of the companies. On the other hand, "products liability litigation risk is increased because of the possibility that the industry appointed panel might conclude that certain additives have problems," and the panel is "unnecessary because the problem will go away if the industry simply discloses some number of its additives" {1316.01, p. 3}.

Bob Northrip, an attorney from Shook, Hardy, and Bacon, proposed that each company do a critical review of its own additives and discard those with problems:

If company testing began to show adverse results pertaining to a particular additive, the company control would enable the company to terminate the research, remove the additive, and destroy the data. Hopefully, the company testing would be done prior to adoption of an additive, but if tests were made of an additive in current use the additive would be discontinued and eliminated from the C&B [Covington and Burling] list before HHS had the opportunity to make adverse comment [emphasis added]. {1316.01, p. 3}

Such a company-by-company sanitized list could then be channeled through Covington and Burling, the Tobacco Institute's counsel, to HHS.

Wells then puts forth the B&W position:

Key factors in assessing the industry position on additives will probably be:

We cannot argue that there is no increased products liability risk inherent in the B&W position. However, the increased risk must be judged against alternatives forecast for the future. If, following disclosure, adverse scientific comment about currently used additives and the claimed failure of the industry to perform adequate testing prior to usage become major public affairs issues, the result would also be an increase in products liability risk. Is

it feasible to expect each of the companies to do review and testing of its additives and remove problematical additives from usage and from the list? If so, then the risk of adverse finding by industry toxicologists is substantially reduced. If not, then the Northrip scheme to prevent adversity subsequent to disclosure is not available.

There appears to be some confusion that the recommendation of an independent industry panel of toxicologists is primarily for the purpose of developing information about our additives. Of course, this is not the case. The industry panel is a formal mechanism for self-policing as part of an industry strategy to gain HHS sanction. The panel is not intended as a substitute for each company's own review and testing of its additives.

The best pitch for B&W's position on additives might be as follows:

The industry can improve public acceptance of its products through HHS approval of industry self-policing of additives. Self-policing will involve research at some point in the future when the research can be satisfactorily set up; immediately the formal mechanism for self-policing would involve only literature review and opinion. It is assumed that the companies will have done their own private review and research of additives and eliminated any which cannot be defended. {1316.01, p. 4}

One of the interesting aspects of the Wells memo is the weight assigned by Wells to public relations and marketing ("public acceptance of [industry] products"). Indeed, the tenor of the memo is that such considerations were deemed of greater importance than the products liability and regulatory concerns that were the lawyer's professional responsibility. Also striking is the suggestion that a panel might serve as a mechanism for self-policing, without having as a primary purpose the development of information about additives, and would instead limit itself to literature review. The industry panel seems proposed primarily as a means of maintaining the privacy—secrecy—of the past use of additives that "cannot be defended." The lawyers seemed to assume that such additives existed. (Indeed, the memo states that Bob Northrip assumed that four or five additives would have problems, not as his own assumption but "because it had been stated as a probability at the table" {1316.01, p. 3}.) If such additives were eliminated from any list given to HHS, then their past use—and the research on health effects—need not be disclosed. Indeed, the suggestion was that past use of toxic additives be affirmatively concealed by destroying adverse data.

The speculation in 1981 that disclosure would blunt criticism was validated in 1994. Following a crescendo of criticism in Congress and in the press about the "secret" additive list, the cigarette manufacturers released a general, overall list in the spring (2). A few days' worth of press stories followed, but little else came of the disclosure.

In the midst of congressional consideration of the bill that required disclosure of additives to HHS, B&W hired outside consultants to test its additives. The Additives Guidance Panel within BAT was to be excluded completely from the project. It is not at all clear that they would even be informed of the project. A note in the documents summarizes a conversation among E. E. Kornhorst; Dr. I. W. Hughes, a B&W scientist; Ernest Pepples, general counsel; and T. Sandefur, who would soon become president. The note, written by Kornhorst on June 8, 1984, reads as follows:

We are going outside to obtain the best expert in toxicology/biological testing. The purpose of this effort will be:

Ernie Pepples and myself will be the only B&W contacts. Once an initial protocol is developed by outside consultants, we will review the same with BAT, given their high involvement with biological and [toxicological] testing. In addition to standard toxicology, the reaction product of combustion might also be considered.

The current Additives Guidance Panel will not be involved in any way in this activity. {1321.01}

The documents contain no information about this program of toxicological testing, nor does the note indicate what exactly prompted this course of action, although the pending congressional action, as well as the revival of products liability suits at about the same time (e.g., the Cipollone case, discussed in chapter 7), may be more than coincidental.