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Product Design

Questions and Answers Concerning Ingredients

Date: 02 May 1990 (est.)
Length: 23 pages
2021522009-2031
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Abstract

Lists questions and answers regarding ingredients added to cigarettes. Discusses types of ingredients such as casing materials and humectants. Defends the use of ingredients in the manufacture of cigarettes. Makes case for why "identity of ingredients" has not been made available to the public. Indicates the industry will "cooperate with the Department of Health and Human Services in its review of the [ingredient] list." Discusses testing of ingredients and addresses concerns about their health effects.

Fields

Notes

Similar to Bates #2040857455. Duplicates Bates #2025597501 and #2025597446.

Hypothesis
Design changes over time
Changes in cigarette design over the past half century.
FTC machine testing and ratings
Design changes to achieve altered FTC smoke machine tar and nicotine ratings, with or without measured changes in human intake.
Inhalation Profile
Are cigarettes designed to cater to individual inhalation profiles?
Mainstream constituent yields
Modification of selected mainstream smoke constituents in response to health concerns.
Measuring overall toxicity
Development of scientifically valid protocols and methods for testing the health and toxicity effects of changes in product design.
Smoke constituent testing
Development of methods for measurement of gas and particulate yields in mainstream and sidestream smoke.
Toxicity and consumer intake
Development of scientifically valid procedures for measuring biological activity and neurological effects of nicotine and smoke constituents.
Use of additives
Modification of tobacco products through use of additives and measuring effects on dependence, behavior, and toxicity.
Keyword
Consumer acceptability (Consumer preference)
Delivery modification
Flavor/ Taste (Attribute measure)
Generally_Recognized_As_Safe
Inhalation (Smoke inhalation)
Mildness (Attribute measure)
Satisfaction
Sensory response
Smoking and Health Controversy
Smoothness/Harshness (Attribute measure)
Tobacco taste (Attribute measure)
Additive
Clove 1 (Clove Leaf Oil and Clove Bud Oil)
Coumarin 2
Eugenol
Design Component
Flavorant
Top dressing (Top flavor)
Named Organization
United States Congress
European Council 3
Covington & Burling (Tobacco Industry law firm)
Tobacco industry law firm. Was involved in organizing the Whitecoat Project.
*Department of Health and Human Services
United States Food and Drug Administration
FEMA (Flavors and Extracts Manufacturers Association) (Trade association of flavor ingredient manufacturers)
HHSC (Health and Human Services Commission, Austin, TX)
Health and Human Services Commission, Austin, Texas
Hunter Committee (British committee investigating tobacco issues)
Independent Committee on Smoking and Health (The Independent Committee on Smoking and Health - U.K.)
The Independent Committee on Smoking and Health is in the United Kingdom
International Agency for Research on Cancer ("IARC") (International Agency for Research on Cancer ("IRAC"))
International Agency for Research on Cancer ("IARC")
Mother Jones 4
Subject
additives
Cancer (Health Effects)
Cocoa (Additives)
health effects
Humectants (Additives to maintain moisture)
Licorice (Additives)
Sensory Effects—Taste (Effects)
Smoothness/Harshness (Effects)
Sugars (Additives)
Glucose/Invert Sugar/Fructose/Sucrose
Test/Consumer Preference (Testing)
Test/Smoke Constituents (Testing)
Test/Toxicity (Testing)
Transfer to Smoke (Measures)

Annotations

1. Clove Additive
  • Description:

    additive

2. Coumarin Additive
  • Description:

    additive

3. European Council Named Organization
  • Synonyms:

    EC

4. Mother Jones Named Organization
  • Description:

    Magazine

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Page 1: lmj48e00
QUESTIONS AND ANSWERS CONCERNING INGR'EDIENTS Why are ingredients used? ii 1 i 7 ~II 1 I .1 1 I i 1 ANSWER: Some ingredients aid in processingitobacco ini the initial stages of cigarette manufacture. These ingredients help in the processing of tobacco but remainin the final cigarette in minute quantities, if at all. Other ingredients are used as casing materials or hu¢nectants. Casing materials, such as sugar, help too smooth and balance the taste of cigarettes, while humectaints keep the tobacco in cigarettes moist. Finalliy,, 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 hawe been used for over 1501years. When Europeans first learned about smoking tobacco f'romm the Indians, the tobacco they smoked was flavored with, citrus peels and:other spices and herbs. In the United States, the use of flavorings has been a comnicn practice since colonial times. Most of the principal processing aids:, casing materials, and humectants,, for example, have not changed' for decades. 3. Why are so many ingredients used?' ANSWER: To put thenumber of ingredients in perspective, it is worthwhile to note that there are some
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2 I J I I i I a 1 I 380 different brands and packings of cigarettes sold in the United States'. The ingredients on the HHS list a!re am aggregate of all the ingredients used., Obviously not a_I ingredients are used in every cigarette. Furthermore, twenty of those ingredients comprise approximately 99% of the total amount, by weight, of ingredlients uised in the industry. The other ingredients are used irn smaller amounts, and most of the ingredients on the list submitted to HHS are used in extremely small quantities as part of fLavor formula- tions. These formulations of'ten include a number of ingredients, b~ut~ typicalindius°try-wideusag~eof` many of these flavor components is under 10 pounds a year. This is in contrast with the over 8'million~poyds of 'i~n the United States tobacco employed in cigasettesCold each year. The flavor formulations used by the companies change occasionally as new products are int~roduced or existing:products are reformulated in response to con- sumer preferences. 4. Why are so many ingredients usedlin American cigarettes, when many fewer ingredients are used in cigar'ettesmadein many other countries? ANSWER: The very premise for this question is not true if you are talking about U.S. style cigarettes. This iss because American stylecig&rettes are a blend of' different types of tobacco, some of'which call for more
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- 3 - I i I ] I 1 I ingredients than others. Consequently, where American style blended cigarettes are the norm, there may be only sligiht differences in, the numbers of ingredients used by manufacturers in different countries. However, there are certain countries, such as the U.K. andl its former colonies, where smokers prefer cigarettes which do: not contain, a blend of different types of tobacco but contain only Virginia: flue- cured tobacco. The latter db not require as many ingre- dients to smooth their taste as do some of the tobaccos found,in bl!end~edcigarettes,. Nevertheless, ingredients are used in Virginia style cigarettes as well. 5. Are ingredients used'in large amounts? ANSWER: ewer tha twenty ingredients such as casing materials (which smooth and balance the f'lavor of cigar- ettes), moisturizers, and major flavors (such as ti menthol ), account for • 99t of' -the weight of ingredients actually, found in cigarettes. Certain ingredients that serve as processing a-ids are used in volume during the earlystages° of manufacturing but theixpresence is virtually eliminated in the manufacturing process. Suichh processing aids remain in the finished cigarette in tracee quantities, if at all. A larger number of'the ingredients are used as aroma f'lavo~rs, to give different cigarette~ brands: . their
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- 4 - I I I i I distinctive aromas, but these substances are in the final cigarette in minuscule amouints. Most of the ingredients comprise,these propriet.aryflavor mixtu:res,and uisage~of' many of these ingredients by the entire industry is under 10 pounds per year. 6. Haven't the cigarette manufacturers started~ usi'ng ir-)ree and more ingredients to compensate for the reduction.of tar and'nicotine imcigarettes? ANSWER: Neither t~he~~ numb~er~ nor quan,ti~ty~ of~ cas~ing~~ materials (,which smooth andlbalance the taste of cigar- ettes) nor~ moisturizing agents have changed, asa~ result of the growing:range of~ tobacco~ product&, including the~ introduction of lower "tar" and nicotine brands. Whilee the number of~ f'l~avor~s~ whi~ch~ cons~~titut~e,the specia~l ar~omas s of individual brands may have increased, it is important to~ no~te~~ that~~ flavors are used i.n, minuscu:1e~~ amounts, the total amount of' all flavors,used constituting less than one tenth of one percent by weight of a finished c~i ga~r et t:e ~. 7~. Why hasm' t the i~de~~nt~~i ty of ~ ingredients been,prov~i~died! to~ the public before? ANSWER: Whilr the identity of the ingredients has not been provided to~the public, the U.S. Government has had access to the.list of' all the ingredients usedl by the sixx major U.S. cigarette~ manufacturers.
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5 I I I I ~ I I I 1 I I I It is common for all companies to guard specific product formulas, and Congress recog,nired this, when it passed the Federal Cigarette Labeling and Adver- tising Act. The Act requires U.S. cigarette manufacturers to submit an annual list of their ingredients but guaran- tees protection against d'i,sclosure.of this information. The flavors added to foods, for example, are treated'as trade secrets and need!not be dlisciosed on the labels of these products. Not only have U. S. manufacturers submitted ingredient lists each year since 198'b in full•compliance with the law, but since 1979 the industry has-voluntarily provided KE S with information about ingredients. Under an agreement reached in 1982, the tnanufacturers had provided' B&S with a list of' commonly-used ingredients added to tobacco in the manufacture of cigarettes. The indlustry agreed then to consult with HSS as it addressed any questions about specific ingredients. Consequently, the U.S. government has had access to information about ingredients for over ten years. Because they contribute to the taste and appeal of individual brands, the identities of specific ingre- dients in cigarettes are also closely guarded'trade secrets. Disclosure of the ingredients used in cigarette manufacture could reveal product formslas that required years'ofresea~rch toldevelop. The Federal C'igarette
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Label!ing and, AdvertisingiAct recognizes the highly confidential nature of ingredients information by directing HH!S to: establish procedures to protect the confid'entialityof theingredient&liste i I I I I I 6. What role did the industry have in the prepaxatio.n of' HHS!' ing~redientreport? ANSWEFt: We regret that the industry had no role ine the preparation of the report. This strikes us asparticularly unfair since as early as 1979 the industry has cooperated with IiES'with respect to the ingredient issue. Well.before the legislation that required that annual lists be submitted,'the industry voluntarily provided information to HHS. The industry has informed FiHS' of itswillingness:s to participate in a scientific review of ingredient usage. Despite these repeated offers, the industry was offered no!role in the HHS'review of the ingredient lists. The industry was not consulted about the types,of data that mig;ht•be reviewed, and industry scientists who are pe,rhaps the most knowledgeable persons about the use of ingredients in cigarettes were not called upon by SMS'' to provide information., Th~us,, HSS~ ignored ap°otential source of highly valuable informati,on, and this resulted in numerous erroneous eonclusions. I
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, :ii t I I I 7 I I 9. 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 treatedias public informatiom. These formulass often have great competitive value and require substantiall time and expense to d'evelop. T'he law therefore allows them to be treated as trade secrets. For example, the flavorings used in hundreds of'foods and in fragrances are treatedlas trade secrets. 10. Why aren"t the ingredients used in cigarettes listed on the package?' ANSWER: The identities of specific ingredlients used in a particular brand of' cigarettes are important trade secrets. "The taste of a specific brand may take years of time and!millions of dollars to develop, and the law recognizes that such valua~ble information is entitled to confidential treatment. For example, the flavors used in hundreds of foods.are treated as trade secrets. 11. The list of'additives which has been supplied to HSS consists of'those substances which are currently added to cigarettes. Save any su!bstances been phased out of use in cigarettes since the submission of'annual lists began? ANSWER: Yes. Like almost all consumer products, from frozen foods to breads or soft drinks, cigarettes undergo constant change as new brand's are introduced and~old brands are modlified! or phased out. Mod'ifications in cigarette formulations may be required to compensate for I
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i I ] I 1 I I I I I changes ini tobacco caused by variati!ons in weather patterns, environmental conditions, agricultural practices, as well as in res'ponse to changes in consumer taste. However, most of the modifications in the composition of cigarettes affect flavors which are already in use and which are employed'.in extremely s:nalll quantities, less thanione tenth of one percent by weight of'a final cigarette. For many of'thes'e ingredients, thee amount used annually is' less than ten.po'unds for thee entire industry. The major ingredients change less of'ten, and many of' them have been used for years. 12'. Are there any substances currently addiedo to cigarettes sold only in other mar'Itets, particularly Third Worldi markets, which are not used in cigarettes sold in the United!States? ANSWER 1: The Federal Cigarette Labelingiand 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 soldn in other countries. However, a number of other count'ries regulate the use of ingredients i~n cigarettes, and the companies comply with these regulations wherever they exist. ANSWER' 2': The Act only requi'res that information be submitted concerningiingredients used in ci'lgarettes sold in the United States. However, we can assert that the cigarettes manufactured for export and sold overseas are.
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- 9 - I i ll I I I ~ ] I 1 identical to the~comparable brands manufactured for sale in the U.S. There is no double standard., All _the ingredients used in the manufacture of cigarettes are acceptable in the countries in which they are used. Indeed, many countries regulate the use of ingredients i!n cigarettes and we comply with these regulations. 13. Are ingredients added to filters, and if so, what i'ngre- dlients are added and what tests have been done to evaluate theiz safety?' ANSWER: The Federal Cigarette Labeling and Advertising, Act requires only that information be submitted concerningiingrediients added to the tobacco used in cigarettes sold in the United States. However, we believe that the additiorn of' ingred'ients to filters is not harmful to smokers. 14. Are the ingredients used in cigarettes harmful? ANSWER: There is no legitimate basis for the conclusion that the:addition to cigarettes of the ingredients on the okers Virtuai1 all substances are ~,1'' t h mf 1 t m s are harmf'ul.. 'e:smai quantities of ingredients used in cigarettes 15. What evidence is there that the ingredients are~not harmful? . y is is ar u o toxic at very high 1-evels, but the is no evidence that I
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I i ] I I I I 1 ANSWER: Most i~ngredlients usedlin cigarettes manufactured in the United States are commonly used in foods, have been reviewed by the Food and Drug Admin istrationi (FDA) and are includied~ on the FDA lists of approved food additives or substances "generally recognized as safe" (GRAS), or on the Flavor Extract Manufacturers Association's GRAS list. Furthermore, governmental bodies in other countries, such as Gseat Britai'mand West Germany, have also evaluated ingredients used in cigarettes i!n those countries. The inclusion of ingredients onithese lists reflects a careful review of available data by scientists. For example, the British ingredients list was developed by a medical and scientific committee appointed by the British.government, the Independent Scientific Committee on Smoking and Health. Virtually all of the ingredients used'by the six leading,U.S'. cigarette manufacturers can be found on the accepted listsf of one or more of the following governmentally affiliated or recognized organizations: the U.S. Food and~Drug Administration, FEMA-GRAS, the U.K. Independent Scientific Committee on Smoking and Health (Hunter-Froggatt Committee), and the relevant government departments and'agencies of'Canada, Belgium, Switzerland, France and the Council of Europe. 11 ,

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