FAWKY ABDALLAH COMPANY, INC. A Suggested Protocol for Studies of Risks of Additives Used in the...

FAWKY ABDALLAH COMPANY, INC.

A Suggested Protocol for

Studies of Risks of Additives

Used in the Production of Cigarettes

American Blended Cigarettes (ABC) Technology


A Suggested Protocol for Studies of Risks of Additives Used in the Production of Cigarettes

A Presentation byFawky Abdallah, Ph.D.

at

An Open Meeting onThe Relative Risk of Non-TobaccoIngredients Added to Cigarettes

Organized by

Life Science Research Office Washington, DC, November 5, 2003



I. DEFINITIONS

II. MANUFACTURING OPERATIONS

III. BLENDING

IV. PROCESSING

V. RECENT DEVELOPMENTS

VI. RECOMMENDATIONS



I. DEFINITIONS

A. Cigarette Smoke

A. Smoke Chemistry

A. Smoke Yield

A. Smoking Qualities

A. Additives



A. Cigarette SmokeThe cigarette is technically a smoke-delivery system.Smoke Formation• The burning cone where the processes of pyrolysis degradation

take place • The thermal gradient zone ahead of the burning cone where

processes of distillation, volatilization, sublimation, cellular eruption, and chemical interactions take place

Nature of Smoke• As MSS travels in the tobacco column, it is subjected to air

dilution through the cigarette paper, tipping, perforation and ventilation, where condensation and re-volatilization take place.

• Cigarette smoke is a dynamic system as evidenced by the different physical, chemical and sensory properties of fresh smoke versus stale smoke or smoke condensate.



B. Smoke Chemistry

• Research and analytical chemists identify the thousands of components in total particulate matter (TPM), commonly called Tar, and in the gaseous phase of cigarette smoke.

• Blenders work on the foundation blend and develop the extenders, casing and flavorings that complement the blend in order to have a total blend cut rag with the target nicotine and sugars while maintaining the desired smoking qualities.

• Process engineers determine the processing parameters and cigarette design configuration that are required to produce the cigarettes with the target tar and nicotine deliveries and acceptable smoking qualities.



C. Smoke Yield

• Toxicologists, biologists and workers on smoking and health are concerned not only with deliveries of tar and nicotine in the cigarette MSS but also its content of specific harmful compounds, such as nitrosamines, benzo-a-pyrine, phenols and carbon monoxide.

• Studies on smoke yield investigate the carcinogenic, co-carcinogenic, antagonistic and other risks of the smoke compounds to test animals in an effort to explore health risks to humans (smokers).



D. Smoking Qualities• Product developers study the physical and chemical

properties of the MSS required for the target cigarettes.

• Sensory analysts refer to smoking qualities as the sensory properties of the “fresh” MSS as determined by flavor (taste, smell and feel), aroma, mildness, after-taste, impact, burning qualities, etc.

• Sensory analysts train and use smoking panels, as a measuring device, to evaluate the smoking qualities of the test cigarettes.

• Marketing specialists conduct consumer tests using focus groups and market surveys to determine overall acceptability of an ABC product in terms of smoking qualities, price, brand identity, etc.


• Casings, flavorings, humectants and any other non-tobacco ingredients added during cigarette manufacturing are collectively called additives.

• Additives cover anything added to tobacco during processing other than water and to the cigarette paper, filter and tipping during making.

• Additives should meet the regulations required by one or more pertinent authorities, such as FDA, IFT, ASTM, FEMA, WHO’s JECFA and CoE.

• Since the actual product consumed is the MSS and not the cigarette per se, the acceptability of certain ingredients for use in food does not necessarily mean approval for use in smoking tobacco products, such as cigarettes.

E. Additives




II. MANUFACTURING OPERATIONS

A. Primary Operation

• Blending and Processing

B. Secondary Operation

• Cigarette Making and Packing


Foundation Blend Flue-cured, burley and oriental

Extenders reconstituted sheet, expanded cut tobacco and cut-rolled expanded stems

Additives casings, flavorings and humectants

Processing six main stages

A. Primary Operation



Cigarette Making Tobacco column: moisture content, weight, density, firmness, filling value, pressure drop, etc.

Cigarette configuration: paper, porosity, filter, tipping, ventilation, perforation, etc.

Cigarette Packing Package design and packaging materials

B. Secondary Operation



A.Why Blending?

B.Basic Principles

C.Deciding Factors

III. BLENDING



No perfect grade• Inherent variations among tobacco types, origins, crops and stalk positions • Incompatibility between elements of tobacco quality

Principle• Each grade has specific traits in terms of quality and value.• The quality of a grade is the degree it contributes to the blend.

Know-how• Good blending is achieved when the quality of the blend is more desirable than the sum of the qualities of the grades therein.

A. Why Blending?



B. Basic Principles


1. Balance Physical, chemical and sensory properties of component grades

2. Categories FF: Full Flavor Grades, MF: Medium Flavor Grades and FG: Filler Grades

3. Criteria No set of criteria fits all types and grades. Different tobacco criteria for each type and within type by origin, crop year and stalk position. Different processing parameters for different blend components, especially burley casing and toasting

4. Philosophy Optimization of quality criteria with cost

availability and continuity


C. Deciding Factors in Blending

1. Blend chemistry Nicotine and sugars

2. Physical properties Filling value and processing ability

3. Smoke chemistry Tar and nicotine deliveries

4. Smoking qualities Sensory properties and burning qualities

5. Economics Cost, availability and continuity of leaf tobacco and extenders



IV. PROCESSING


A.Primary Processing

B.Why Casings?

C.Why Flavorings?

D.Role of Additives


A. Primary Processing


A typical ABC primary operation consists of six main stages:

1. Burley Casing & Toasting (Heat Treatment)

2. Total Blend Casing

3. Expanded Cut Tobacco (ECT)

4. Cut-Rolled Expanded Stems (CRES)

5. Total Blend Cutting, Drying, Cooling

6. Flavorings (Top Dressing)

Option: Top Casing may be applied before cutting.


Casing is an integral part of processing any ABC product.

Ingredients Sugars, licorice, cocoa, fruit concentrates, humectants and water

Benefits1. Sugars improve the overall sensory quality, esp. smoke flavor.

2. Licorice, cocoa and fruit concentrates contribute to basic taste.

3. Humectants improve tobacco processing ability and increase its moisture-holding capacity, thus extending the product’s shelf

life.

4. The casing’s solids act as a cost-reducer, by replacing tobacco in the cigarette rod while maintaining the same puff count.

B. Why Casings?



Flavoring is an integral part of processing any ABC product.

Ingredients Aroma chemicals, essential oils, natural and/or synthetic extracts and commercial flavorings

Benefits 1. Ameliorates off taste and negative flavor attributes usually associated with tobacco smoke

2. Generates a balanced smoke flavor matrix 3. Imparts “signature” pack aroma and smoke flavor

that are unique to each particular ABC product

Formula There is no formula or ratio that fits all ABC products. Each ABC product requires a formula and ratio that

complement the particular blend.

C. Why Flavorings?



• Additives should be used with care in order to complement, not overpower, the basic tobacco characters, and positively contribute to processing ability, smoking qualities and safety.

• The increase in demand to produce “safer” cigarettes with lower yield and acceptable smoking qualities led to efforts to develop new additives and application techniques.

• Additives can be used to enhance the signature flavor matrix and pack aroma of the “safer” cigarettes with reduced yield.

Additives’ Golden RuleUse a minimum number of components at lowest possiblelevels that can provide maximum positive effects on physicalproperties, smoking qualities and overall smoke chemistry interms of safety, while preserving the ABC product integrity.

The Use of Additives



V. RECENT DEVELOPMENTS


A.New Target and New Direction

B.Sensory Testing

C.What “Tar”?

D.Acceptability and Safety

E. Review of Literature



A. New Target & New Direction

Target Development of “safer” cigarettes with MSS that has:- Lower-tar and nicotine deliveries

- Reduced yield of harmful compounds - Acceptable smoking qualities

Direction Work on breeding and cultural practicesMake blend changes in the grades of each sub-blendAdjust extenders: recon, ECT and CRESReview additives: casings, flavorings and humectants Modify cigarette design: Tobacco rod’s weight, filling value, density, etc., and Cigarette’s paper, filter, tipping, plug wrapper, ventilation, perforation, etc.


B. Sensory Testing• There are many studies on the chemistry and biological

activity of cigarette smoke; however, the most advanced chemical devices cannot “sense” the qualitative aspect of MSS and its sensory properties as perceived by the smoker.

• Recent efforts to develop “safer” ABC products with lower yield and acceptable smoking qualities have revitalized the important role of sensory testing.

• Adequate smoking panels should be used as a measuring device parallel to the chemical and physical testing devices now being used in product development.



C. What “Tar”?• The total particulate matter (TPM) of the cigarette MSS is

commonly called “tar”, a term that is oftentimes misleading.

• The tar delivery per se does not necessarily reflect specific sensory properties or indicate a certain safety factor.

• Many ABC brands have similar tar delivery but differ greatly in smoking qualities as reflected by acceptability in the market place.

• This presumably reflects qualitative differences between tars that may also reflect differences in the degree of safety, in terms of the level of harmful compounds such as benzo-a-pyrene, nitrosamines, phenols, CO, etc.



D. Acceptability and Safety

Besides acceptability in terms of smoking qualities, the safety of MSS in terms of deliveries of tar, nicotine and other harmfulcompounds should also be considered.

Complexity Acceptable smoking qualities are oftentimes incompatible withlow tar and nicotine deliveries in the MSS.

Solution Adequate application of technology and know-how throughproduct development programs in two major areas:

• Blending and processing• Cigarette design configuration



Role of Blending and ProcessingBlend. Replace some of the high-yield FF grades with lower yield MF grades while maintaining acceptable smoking qualities.

Extenders. Increase the inclusion of recon in order to reduce thetar delivery while preserving the smoking qualities. Also, increasethe ratio of expanded cut tobacco and/or CRES to reduce tar.

Additives. Adequately adjust the formula and application rate ofthe casings, flavorings and humectants to enhance the flavorattributes of the ABC product with reduced yield.

Processing. Develop techniques that can improve processingability and increase filling value and moisture-holding capacity ofthe cut rag with reduced tar.



Role of Cigarette Design• Although blending and processing play an important role in

developing lower-yield cigarettes with acceptable smoking qualities, cigarette design configuration plays an equally important role.

• For many years the reduction of tar and nicotine in MSS washandled mainly through cigarette design, using advances in paper porosity, filter, tipping, ventilation, perforation, etc. This

led to gradually reducing the average deliveries in MSS of all cigarettes sold in the U.S. by about one half over the last 40 to 50 years.

• Further reduction should be undertaken through coordinationbetween blending and processing and cigarette design; otherwise, the resulting lower-yield cigarettes will have undesirable smoking qualities.



E. Review of Literature

Following are the main recent publications and on-goingstudies on the evaluation of the health effects and relative risks of non-tobacco ingredients added to cigarettes

during manufacturing:

• JTI’s Paschke et al 50-year review 1952-2002

• PM’s Carmines et al 4 parts 2002

• RJR’s Rodgman et al 2 parts 2002

• BAT’s Baker el al on-going 2003

• LSRO’s independent on-going 2003



Results of Studies

• To date, almost all studies indicate that the commercially used ingredients do not change the toxicity of smoke as measured in specific assays.

• The added ingredients have no effect on the levels of most smoke constituents that are known to be relevant to smoking- related diseases.

• Neither flavoring nor casing and humectant ingredients added during today’s cigarette manufacturing in the USA increase the toxicity of cigarette smoke.



Controversies

• A large number of studies reveal scientific controversies about the risks of cigarette ingredients.

• The controversies are due to the diversity of test materials, test conditions and test procedures among investigators.

• The complexity of studying the role of ingredients in the health risks of cigarette smoking is also due to the lack of:• Standardized procedures to test “fresh” smoke • Ethically- accepted methodologies to employ human

subjects (smokers) to participate in the required tests



VI. RECOMMENDATIONS

A. Concept of “Safer” Cigarettes

B. Suggested Protocol

C. Parallel Programs

D. Smoking Behavior



• Recent research and product development studies indicate that it may be possible to make “safer” cigarettes with reduced yield of tar, nicotine and harmful compounds, but the outcome most probably will be of undesirable smoking qualities.

• The current challenge is to develop the “safer” cigarettes with reduced yield while maintaining acceptable smoking qualities.

• Developing a “safer” cigarette with inferior smoking qualities does not contribute to safety if no one smokes it.

• It is the obligation of the cigarette industry along with pertinent state and national institutions to join efforts in order to meet this challenge.

A. Concept of “Safer” Cigarettes



To support the ongoing efforts to develop “safer” cigarettes withacceptable smoking qualities, the health effects and relative risks

ofadditives should be investigated.

I suggest that this should be done through an aggressive andprogressive multi-disciplinary working arrangement, or Protocol,reflecting the joint efforts of the cigarette industry, covering:

• Blending & Processing• Cigarette Manufacturing• Product Development• Smoke Chemistry• Biology and Toxicology• Sensory Testing• Market Research • Data Processing

B. Suggested Protocol



C. Parallel Programs• The use of additives, as a tool in the development of “safer”

cigarettes with acceptable smoking qualities, represents a serious challenge.

• This challenge should be addressed through coordinated research studies by all concerned, instead of separate and unrelated studies that oftentimes lead to contradictory results and unnecessary recriminations.

• I suggest that, along with the industry’s collective effort, or Protocol, similar efforts or Parallel Programs, should be carried out by the pertinent state and national institutions.



D. Smoking Behavior• Besides the possible health risks of additives per se, the

safety of the lower-yield cigarettes depends on how and to what extent the smokers actually smoke the cigarettes.

• Studies on smoking behavior play an important role in the ongoing effort to develop “safer” cigarettes with

acceptable smoking qualities.

• The behavioral aspects and sensory responses of the prospective smokers will determine the degree of safety that each reduced-yield cigarette is actually providing.



Thanks for your attention.

I will now entertain yourquestions or comments.

Fawky Abdallah


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