Bliley Lorillard
Questions and Answers Concerning Ingredients
Abstract
Lists questions and answers regarding the ingredients added to cigarettes. Discusses types of ingredients e.g. casing materials, humectants etc. Defends the use of ingredients in the manufacture of cigarettes. Makes case for why "the identity of ingredients" has not been made available to the public. Discusses how the industry will "participate in HHS' scientific review of the list." Addresses the use of ingredients in other markets, particularly Third World markets. Notes ingredient testing and addresses concerns regarding effects on health. Duplicates Bates #2023264652, #2024948396, #2028455982, #2046463097, #2047999331 and #2501152746.
Fields
- Type
- STATEMENT
- Position paper
- Draft material
- Author (Organization)
- Covington & Burling (Tobacco Industry law firm)Tobacco industry law firm. Was involved in organizing the Whitecoat Project.
- Recipient
- Certain Members, O.F. The Joint
- Defense
- Spears, Alexander White, III (LOR President & CEO)Associated with CTR, used as an expert in the Mississippi case.
- Stevens, Arthur Joseph (LOR Sr. VP '89-95 and TI Communications)Served on Lorillard Board of Directors 1985-92, was Senior Vice President from 1989 to 1995, served as General Counsel for Lorillard '93-95. Served on Tobacco Institute Communications Committee.
- Named Organization
- Mother Jones Magazine
- National Toxicology Program
- United States Department of Health and Human Services
- United States Food and Drug Administration
- FEMA
- Flavors and Extracts Manufacturers Association IARC
- Covington & Burling
- Region
- Germany
- Great Britain
- United States
- Additive
- Cloves
- Coumarin
- Eugenol
- Keyword
- Carcinogen
- Exposure
- Federal Cigarette Labeling and Advertising Act
- Generally_Recognized_As_Safe
- Proprietary
- Trade secrets
- Thesaurus Term
- adverse effects
- cigarette additive
- government activity
- government agency
- tobacco industry internal policy
- tobacco industry structure
- cigarette ingredient
Document Images
DRAFT - March 27, 1986
PRIVILEGED AND CONFIDENTIAL
ATTORNEYS' WORK PRODUCT
QUESTIONS AND ANSWERS CONCERNING INGREDIENTS
i. Why are ingredients used?
ANSWER: Some ingredients aid in processing tobacco in
the initial stages of cigarette manufacture; these
ingredients increase the efficiency and yield of proces-
sing operations but remain, in the final cigarette in
extremely small and often undetectable amounts. Other
ingredients are used as casing materials or humectants.
Casing materials help to smooth the taste of cigarettes,
while humectants keep the tobacco in cigarettes moist.
Finally, many of the ingredients are used to give
individual brands of cigarettes their distinctive flavor
and aroma.
2. How long have ingredients been used in cigarettes?
ANSWER: Ingredients have always been used in cigarettes.
Most of the principal processing aids, casing materials,
and hu~ectants, for example, have not changed for decades.
Many of the majo~ flavoring agents have also been in use
for an extensive period. Other flavors have been added
or eliminated from time to time as new products have been
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introduced or existing products have been reformulated~ in
response to changing consumer preferences.
3. Why are so many ingredients used?
ANSWER: A relatively small number of ingredients,
perhaps one-fourth of those on the list submitted to HHS,
are separately added directly to tobacco during cigarette
manufacture. Fifteen of those ingredients comprise over
99% of the total amount, by weight, of ingredients used
in the industry. The other ingredients are used in
smaller amounts, and most of the ingredients on the list
submitted to HHS are used in extremely small quantities
as part of flavor formulations purchased by the cigarette
manufacturers. These formulations often include a number
of ingredients, but typical industry-wide usage of most
of these flavor components is under 1,0 pounds a year.
The flavor formulations used by the companies change
occasionally as new products are introduced or existing
products are reformulated in response to consumer pref-
erences.
4. Are ingredients used in large amounts?
ANSWER: Ingredients do not comprise a significant
portion of the final cigarette. Certain ingredients
which serve as processing aids are used in volume during
the early stages of manufacturing but generally disappear
in the manufacturing process. The residual amounts of
such processing aids in. the final cigarette will be small
and often undetectable. A small number of casing materials,
moisturizers, and major flavors account for the great
bulk o.f ingredients actually in cigarettes.
A larger number of the ingredients are used as
flavors, but these substances are in the final cigarette
in minuscule amounts. Most of the ingredients are
constituents of proprietary flavor mixtures purchased
from flavor suppliers, and usage of most of these ingredi-
ents by the entire industry is under i0 pounds per year.
These ingredients will normally constitute less than one
tenth of 1 percent by weight of the final product.
Haven't the cigarette manufacturers started using more
and more ingredients to compensate for the reduction of
tar and nicotine in cigarettes?
ANSWER: Most of the major ingredients used today have
been used in cigarette manufacture for decades. It is
true that, in recent years, a larger number of flavoring
agents have been used -- in part because of an increased
number of new brands and changes in existing brands.
H, wever, these flavoring ingredients are generally used
in extremely small amounts and, in totality, represent
less than one tenth of 1 percent by weight of the final
cigarette.
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Why hasn't the identity of ingredients been provided to
the public before?
ANSWER: It is common for companies in highly competi-
tive industries to guard specific product formulas.
The
flavoring, agents added to foods and the fragrances
included in cosmetics, for example, are treated as trade
secrets and need not be disclosed on the labels of these
products.
Because they contribute to the taste and appeal of
individual brands, the identities of specific ingredients
in cigarettes are also closely guarded trade secrets.
Disclosure of the ingredients used in cigarette manu-
facture could reveal product formulas that required years.
of research to develop. The Federal Cigarette Labeling
and Advertising Act recognizes the highly confidential
nature of ingredients information by directing HHS to
establish procedures to protect the confidentiality of
the ingredients list.
Even though the ingredients are trade secrets, it
should be noted that prior to the passage of Section 7(a)
of the Federal Cigarette Labeling and Advertising Act in
1984, the industry had voluntarily cooperated with HHS on
the question of ingred~e|,~s. Under an agreement reached
in 1982, the manufacturers had provided HHS with a list
of commonly-used ingredients added to tobacco in the
manufacture of cigarettes. The industry agreed then to
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consult with HHS as it addressed any questions about
specific ingredients.
What specific steps will industry take to cooperate with
the Department of Health & Muman Services in its review
of the list?
ANSWER: The industry plans to participate in HHS'
scientific review of the list. We are waiting for HHS to
complete its initial evaluation of the list before
determining what specific steps should betaken.
Don't consumers have the right to know what is in the
products they buy?
ANSWER: The formulas of any number of consumer products
are not treated as public information. These formulas
often have great competitive value and require substan-
tial time and expense to develop. The law therefore
allows them to be treated as trade secrets. For example,
the flavorings used in hundreds of foods and the fra-
grances used in cosmetics are treated as trade secrets.
o
Why aren't the ingredients used in cigarettes listed on
the package?
ANSWER- As noted above, the identities of specific
ingredients used in a particular brand of cigarettes are
important trade secrets. The taste of a specific brand
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may take years of time and millions of dollars to develop,
and the law recognizes that such valuable information is
entitled to confidential treatment.
i0.
The list of additives which has been supplied to HHS
consists of those substances which are currently added to
cigarettes. Have any substances been phased out of use
in cigarettes since the request for this list was first
made?
ANSWER: Like almost all consumer products, from frozen
foods to breads or soft drinks, cigarettes undergo
constant change as new brands are introduced and old
brands are modified or phased out. Most of the modifi-
cations in the composition of cigarettes affect flavor
constituents used. in extremely small quantities. For
many of these ingredients, the amount used annually is
less than ten pounds for the entire industry. The major
ingredients change less often, and many of them have been
used for years.
The cigarette manufacturers have complied with the
procedures adopted by HHS by submitting an initial list
on April 2, 1986. An annual list will be submitted
starting December 31, 1986. Any future changes in the
ingredienti: used in cigarettes will be reflected in the
lists submitted annually.
Ii.
12.
Are there any substances currently added to cigarettes
sold only in other markets, particularly Third World
markets, which are not used in cigarettes sold in the
United States?
ANSWER: The Federal Cigarette Labeling and Advertising
Act only requires that information be submitted
concerning ingredients used in cigarettes sold in the
United States, and we have not compiled information on
cigarettes sold in other countries. --
Are ingredients added to filters, and if so, what
ingredients are added and what tests have been done to
evaluate their safety?
ANSWER: The Federal Cigarette Labeling and Advertising
Act only requires that information be submitted concerning
ingredients-added to the tobacco used in cigarettes sold
in the United States. We have not compiled information
on ingredients which might be added to other portions of
the cigarette.
13. Are the ingredients used safe?
ANSWER: The companies do not believe that the addition
to cigarettes of the ingredients on the list is harmful
to smokers.
14. What evidence is there that the ingredients are safe?
ANSWER: Most of the ingredients are approved for use
in foods by the Food and Drug Administration and are
included in other lists of approved food, drug, and
cosmetic ingredients in the United States and other
countries. The inclusion of ingredients on these lists
generally reflects a careful review of available data by
scientists. Many of the ingredients are also included on
approved lists of tobacco additives in Great Britain and
Germany. These lists were prepared by scientists familiar
with the uses of ingredients and information on their
safety.
The companies have likewise reviewed available
scientific evidence about the ingredients on the list.
This. includes test data found in the published scientific
literature, as well as the results of unpublished research,
on many of the ingredients. The safety of the ingredients
used in foods and other articles for human consumption is
supported by the available data. The data also indicate
that the presence of ingredients in cigarettes does not
materially affect the chemical composition of cigarette
smoke.
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i'5 o
Are there any substances wh.ich have historically been
used as additives in cigarettes which are now regarded as
hazardous?
16.
ANSWER: In the past, the cigarette manufacturers have
reviewed the questions that have arisen concerning
ingredients. The companies do not believe that the
addition to cigarettes of ingredients formerly or cur-
rently used has been harmful to smokers.
Why ~s there any reason to think that an ing:redient is
safe just because it has been used for a long period of
time?
ANSWER: Longstanding use alone may not establish an
ingredient's safety. However, most of the major ingredi-
ents used in large quantities in the production of
cigarettes are either foods or are approved for use in
foods or in the manufacture of food products. For these
major ingredients, test data are available concerning
both their food and tobacco applications. Despite
extensive use, no evidence has been presented to-estab-
lish that the addition of these ingredients to cigarettes
is harmful to smokers.
17.
What effect do ingredients have on non-s~kers exposed to
cigarette smoke?
ANSWER: As stated earlier, the companies do not believe
that the addition to cigarettes of the ingredients on the
list is harmful to smokers. The companies likewise do
not believe that the addition of ingredients to cigarettes
is harmful to non-smokers who may be exposed to cigarette
smoke.
18.
Have each of the ingredients been tested to ensure that
they are safe?
ANSWER: Since most of the ingredients are approved, for
use in foods, testing to determine their toxicity has
been conducted, and the results have been made available
to FDA. The tobacco companies have.conducted additional
testing on many ingredients and mixtures of ingredients
which attempts to address the conditions encountered
during cigarette smoking. Most of the ingredients used
in the largest quantities and selected components of
flavor mixtures have been tested..
19. What kinds of tests have been done on ingredients?
ANSWER: The need for testing, and the types of tests to
be conducted, depend on a range of factors. There is no
accepted testing methodology for evaluating ingredients.
Nonetheless, depending on the circumstances, the research
conducted includes inhalation studies, mouse skin
painting studies, acute and chronic toxicity studies, and
various in vitro studies. In addition, tests have been
done to determine whether the presence of ingredients in
