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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction 4 Products for Tobacco Exposure Reduction Several tobacco-related products have been introduced recently with potential exposure reduction properties. Two classes of pharmacutical products approved for smoking cessation are also potential exposure reduction products. The chapter describes these products and concludes with a review of regulatory strategies currently in place. TOBACCO AND TOBACCO PRODUCTS At first glance, cigarettes seem very simple in construction and design. Typical cigarettes contain a tobacco blend, flavorings and other additives, filters, and cigarette paper. The impression of simplicity of cigarette construction wanes as each component is taken into consideration. There are various combinations of tobacco blends, filter types, and ventilation methods. Manufacturers have used various means of modifying their products to capture and shape the smokers’ preference and acceptability of popular brands. Some modifications have had the potential for harm reduction. This section describes current tobacco products, including the curing and processing of tobacco, design features (both historical and contemporary) with exposure reduction potential, and currently available potential reduced-exposure products (PREPs). Conventional Tobacco Products There are a wide variety of tobacco products in the United States including cigarettes, cigars, cigarillos, bidis, kreteks, and different types
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction of smokeless tobacco. The most common form of a tobacco product in the United States is the manufactured cigarette. A cigarette is considered to be any roll of tobacco wrapped in paper or in any substance not containing tobacco. Cigarettes can be either manufactured or individually constructed. Cigarettes are lit, and the burning process allows smoke to be inhaled at the other end. Cigarettes are approximately 8 mm in diameter and 70 mm to 100 mm in length. A cigar is a roll of tobacco wrapped in leaf tobacco or in any substance containing tobacco. There are four main types of cigars: little cigars, small cigars (sometimes called cigarillos), regular cigars, and premium cigars. Little cigars contain air-cured and fermented tobaccos. Little cigars are wrapped either in reconstituted tobacco or in cigarette paper that contains tobacco and/or tobacco extract. Some little cigars have cellulose acetate filter tips and are shaped like cigarettes. Cigarillos are small, narrow cigars with no cigarette paper or acetate filter. Regular cigars are available in various shapes and sizes and rolled to a tip at one end. The dimensions vary from 110 to 150 mm in length and up to 17 mm in diameter. Regular cigars weigh between 5 and 17 grams. Premium cigars vary in size, ranging from 12 to 23 mm in diameter and 12.7 to 21.4 cm in length. Bidis are made by rolling dried leaf into a conical shape around approximately 0.2 grams of sun-dried, flaked tobacco and securing the roll with a thread. Bidis are used extensively in India, the rural areas of several countries in Southeast Asia, and some parts of the United States. There have been no scientific studies or assessments of the physical characteristics and pharmacologic properties of Indian bidis. In comparison, American versions of bidis were shown to have higher percentages of tobacco by weight (94% vs. 42.5% respectively) and lower levels of nicotine (16.6 mg/g vs. 21.2 mg/g) than Indian bidis. Kreteks are a type of small cigar containing tobacco, cloves, and cocoa, which gives a characteristic flavor and ‘honey’ taste to the smoke. Kreteks are indigenous to Indonesia but are also available in the United States. Smokeless tobacco includes tobacco that is sniffed, dipped, or chewed according to the type and constitution of the tobacco. Smokeless tobacco products are made from dark or burley-leaved tobacco. Smokeless tobacco is often referred to as oral tobacco or spit tobacco. Snuff is a cured, finely ground, flavored tobacco product that is sold in tins or cans and is available in two main types: dry and moist. Dry snuff is fire-cured powdered tobacco and is sniffed. After initial curing, the tobacco is fermented further and processed into a dry powdered form. It has a moisture content of less than 10%. Moist snuff is a granulated tobacco product that is made from both air-cured and fire-cured tobacco and multiple additives. Moist snuff is used by placing a pinch (or “dip”)
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction between the lip or cheek and gum. Moist snuff consists of tobacco stems and leaves that are processed into fine particles or strips. It has a moisture content of up to 50%. It is sold in both loose form and ready-to-use pouches (also called packets or sachets) that contain about 0.5 grams tobacco. Moist snuff is available in two varieties, according to the size and consistency of the tobacco: long cut and fine cut. Moist snuff is by far the more prevalent form of snuff used in the United States. Chewing tobacco is a coarsely shredded, flavored tobacco that is sold in pouches of tobacco leaves or in “plug” or “twist” form. Chewing tobacco is chewed or held in the cheek or lower lip. Curing, Blending, and Processing The genus Nicotiana is indigenous to the Americas. A member of the family Solanaceae, Nicotiana contains more than 64 species. In the United States, the tobacco used in cigarettes, cigars, and smokeless products comes from the species N. tabacum and can be categorized by the three traditional methods used in curing or by the geographic region in which it is grown. These are distinguished by important differences in sugar, nicotine, and nitrogen content (Browne, 1990). Flue curing uses high heat to speed the curing process and control humidity. The principal chemical change is conversion of starch to sugars. During the aging of cured tobacco, enzymatic oxidation of amino acids and carbohydrates takes place. The water content, acidity, and concentration of malic and citric acids increase. There are other, undefined chemical changes that occur, resulting in increased aroma and a less bitter taste. Flue-cured tobacco is also called Bright (also known as Virginia) tobacco. These plants are grown in sandy soils from Virginia to Florida, but their agriculture is centered in North Carolina. These tobaccos generally have low-nitrogen, high-sugar content. The smoke from Bright is acidic with a light aroma. Bright tobacco has medium nicotine content. Air curing uses heat only to maintain temperature and humidity, not to speed the curing process. The primary chemical changes that occur during air curing are protein degradation, polyphenol formation, and a change in the composition of organic acids. Air-cured tobacco consists of Burley and Maryland tobacco. These plants are grown in silt loams in Kentucky, Tennessee, and western North Carolina and in sandy loam soils in southern Maryland. These tobaccos have very low-sugar content and are more heavily fertilized with manure and artificial fertilizer than the flue-cured products. Air-cured tobaccos have an alkaline smoke, fuller aroma, and high nicotine content. Maryland tobacco also has the quality of continuing to burn on its own, making it less likely to self-extinguish. Sun-cured or oriental tobaccos (Oriental) require a Mediterranean
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction climate and come mostly from Turkey, Greece, Yugoslavia, Bulgaria, and Russia. They are cultivated with little fertilizer. Oriental tobaccos have mild, aromatic smoke and low nicotine content. Cigarettes, cigars, and smokeless products use blended tobaccos. The largest component of most cigarette blends in the United States is Bright tobacco (Browne, 1990). Blends are made to achieve specific pH, taste, burning characteristics, and nicotine content. The type of tobacco blend found in cigarettes significantly affects the pH, nicotine content, and toxicity of the smoke produced. The blend can be manipulated by a choice of 60 species and 100 varieties of tobacco. Almost all commercial tobacco products, however, use N. tabacum species and a small amount of N. rustica in some specialized tobacco products. Cured tobacco lines can contain between 0.2 and 4.75% nicotine (depending on plant genetics, growing conditions, and place of harvest from the stalk; NIH, 1996). In addition to tobacco leaf, reconstituted sheet tobacco is also used in most commercial products. Cigarettes primarily made with reconstituted tobacco deliver lower smoke yields of tar, phenols, and benzo [a] pyrene (NIH, 1996). Reconstituted tobacco sheet is also used for economic reasons and for the introduction of additives that change various characteristics of the cigarette. Reconstituted tobacco results from a process that combines stems, leaves, and tobacco scrap into a slurry or from making a tobacco “paper,” which is cut (Browne, 1990). Another alternative to leaf tobacco is puffed, expanded, or freeze-dried tobacco (Hoffman and Hoffman, 1997; NIH, 1996). Less tobacco is therefore needed to fill a cigarette while still providing a sensation of fullness and substance in the smoke. While tobacco is being cured, it loses some of its integrity through water loss. Expanding tobacco increases its filling capacity in the final tobacco column of the cigarette by primarily restoring the original cellular structure. This process is performed by expanding the cells with water, steam, and various organic or inorganic fluids depending on the manufacturers patent (David and Nielsen, 1999; NIH, 1996). The pH strongly influences the concentration of free nicotine in tobacco smoke. The pH is influenced by the type of tobacco used, as well as by the addition of ammonia to the manufacturing process. Free nicotine has a greater effect on the sensory nerves in the mouth and throat than protonated nicotine, which contributes to the impact or strength of the cigarette. Free nicotine is absorbed more rapidly than protonated nicotine across mucous membranes. The phenomenon of more rapid absorption of nicotine at higher pH has been documented in people using different brands of smokeless tobacco. Free nicotine is absorbed through the mouth from alkaline pipe, cigar, and dark cigarette smoke, but not from acidic smoke of blonde tobacco cigarettes. Free nicotine may be absorbed more
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction quickly from the lungs of cigarette smokers as well, although this has not yet been demonstrated experimentally in smokers. The nitrate content influences the carcinogenic potential of smoke. Nitrogen oxides formed during pyrolysis are free-radical precursors of the polycyclic aromatic hydrocarbons (PAHs). As nitrate concentration in tobacco increases, the synthesis of benzo[a]pyrene (BaP), a carcinogen, is inhibited. Air-cured tobaccos have higher content of nitrates than sun-cured or flue-cured tobaccos and, therefore, lower BaP content. However, the higher the nitrate concentration, the higher are the levels of tobacco specific-nitrosamines (TSNAs), also a known carcinogen. Hundreds of additives are used in the manufacturing of cigarettes. Several additives are known to have toxic properties. For example, glycerol is a humectant used in cigarettes. Glycerol may lead to the formation of acrolein, a ciliotoxic agent, and diethylene glycol can be converted to ethylene oxide, a carcinogenic compound (Hoffmann and Hoffmann, 1997). Eclipse, that heats but does not burn tobacco, uses glycerol particles as the carrier for nicotine. The glycerol level in smoke from this product is much higher than in conventional low-yield products. As described above, some additives can influence other tobacco constituents (e.g., the role of ammonia in nicotine protonation and TSNA formation). Although some additives have toxic potential, the concentration of these compounds is low (other than those listed above) and their relative contribution to overall toxicity compared to compounds such as TSNA, BaP, and carbon monoxide (CO) is not definitively known. The toxicity of individual ingredients is sometimes well described, but little is known about how toxicants affect the body when smoked in combination (U.S. DHHS, 2000). The current emphasis on additive disclosure focuses on the consumer’s right to know and on understanding better which additives are used to increase the acceptability (e.g., by improving taste and smoothness) of the product to the consumer. Menthol is a common additive used for flavor and customer acceptability. Early advertisements for menthol products claimed a “soothing” effect on irritated throats. Menthol can be added to cigarettes in several ways including addition to the tobacco shred through an ethanol spray and addition to the filter or packaging. Approximately 3 mg of menthol is added per cigarette. The rest is lost through the filter, sidestream smoke, and in packaging (Browne, 1990). Because menthol is an anesthetizing agent, it has been hypothesized that it may be easier to inhale deeper when smoking a mentholated cigarette. This might also help explain why there are higher rates of lung cancer among blacks despite their lower daily cigarette consumption than whites, who tend to not smoke mentholated cigarettes. Various studies, however, have produced mixed results on the subject (Carpenter et al., 1999; Clark et al., 1996; Gaworski et al.,
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction 1997; Kabat and Hebert, 1991; McCarthy et al., 1995; Sidney et al., 1995; Women who smoke menthol cigarettes have greater nicotine exposure, 1999). Cigarette paper is second to tobacco as the most variable component in producing cigarettes. The degree of ventilation allowed by the paper can be manipulated in the production process. More porous cigarette paper has been shown to reduce smoke yields of CO and tar as well as volatile nitrosamines, TSNAs, and BaP through dilution. Increased permeability does not reduce the low-molecular-weight gas-phase components in smoke however (NIH, 1996). For a more detailed discussion of the toxicology of smoke, see Chapter 10. A new paper has been introduced for Merit cigarettes, which claimed to decrease the smoldering of cigarettes when dropped onto fabric. The new technology consists of a modified wrapping paper that reduces the amount of oxygen entering the cigarette, therefore slowing the rate at which it burns. This could decrease the 25% of fatal residential fires started by smoldering cigarettes (Meier, 2000). New York became the first state to pass legislation imposing fire safety standards on cigarettes (Cigarettes-fire bill, 2000). Smoke Yields The procedure for measuring the tar and nicotine yields of mainstream smoke (i.e., the “smoking machine”) is standardized for consistency between laboratories and from product to product. There are two methods in widespread use: the Federal Trade Commission (FTC) method and the International Standards Organization (ISO) method. Differences between these two are minor, and puff volume, duration, and interval are common to both standards. Particulate matter is collected on Cambridge filter pads as what is called “wet total particulate matter” (Davis and Nielson, 1999). Tar is a generic term for the total particulate matter minus the nicotine and water. The material that passes through the filter is called the vapor phase. This is described in more detail in Chapters 10 and 11. Tar yields are influenced primarily through filtration, ventilation (tip ventilation holes and paper porosity), and the choice of tobacco processing and blend. As with any agricultural product, there is natural variation from year to year. In the interest of manufacturing a consistent product, prepared tobacco is blended with stock of crops from previous years to maintain a uniform product line. Finally, the burn rate of cigarettes has been proven to influence smoke yields. The faster the burn rate, the lower the tar yields will be, according to FTC measurements. Shredded tobacco can facilitate a faster burn rate (Davis and Nielsen, 1999), as can the use of accelerants.
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction The FTC test does not account for the wide range of smoking behaviors and compensation that occurs naturally among smokers, thus, the standardization has come under great criticism. Human smoking behavior can greatly influence the tar, nicotine, and CO levels to which smokers are exposed. The yields of so-called light and ultralight cigarettes have changed over the years but have produced similar nicotine levels across yields. These terms are not official government designates and are often part of the trademarked name of a product. In general, however, ultralights have less than 6 mg of tar, light cigarettes have between 6 and 15 mg of tar, and “regular or full-flavored” cigarettes have more than 15 mg (NIH, 1996; Sweeney et al., 1999). Although there is not a standard nicotine classification, a study by Byrd et al. (1995) comparing measured and FTC-predicted nicotine uptake in smokers described nicotine levels in products they categorized as 1 mg tar, ultralow-tar, full-flavor low-tar, and full-flavor cigarettes. The mean FTC nicotine yields were 0.14, 0.49, 0.67, and 1.13 mg per cigarette, respectively. FTC measures, particularly for low-tar cigarettes or for cigarettes with filter ventilation holes, do not, however, reflect true exposures in humans. Cigarettes are positioned in the smoking machines in a manner that allows air to enter the perforated filters. These holes are often covered by the lips or fingers of smokers (Hoffman and Hoffman, 1997). In addition, smokers of low-yield products compensate by inhaling more deeply, holding a puff in the lungs for longer periods, or puffing more frequently. Conventional and Historical PREP Technology Two cigarette design features that reduce toxin yields as measured by the FTC are dilution and filtration. Dilution is achieved primarily with ventilation, although paper porosity can also increase smoke dilution. Cigarette holders popular in the 1930s provided ventilation. Ventilation is achieved today with small holes around the filter. The primary means of toxin reduction however is the addition of a filter component on the mouth end of the cigarette to trap certain components before they are released from the cigarette in the form of smoke. The majority of cigarettes sold in the United States today have cellulose acetate filters. Most cellulose acetate filters reduce tar and nicotine yields by 40–50% compared to nonfiltered cigarettes (Davis and Neilson, 1999). Because filter materials influence tar and nicotine smoke yields as well as taste to differing degrees, filter preference has become regionalized. Filters that contain charcoal provide selective removal of a range of vapor-phase smoke constituents and are more popular in Japan than in the United States. Although Japanese and American smokers smoke a
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction comparable numbers of cigarettes per day there is a lower incidence of lung cancer in Japan (NIH, 1996). Many factors play a role in the differences in cancer rates between countries. It is speculated that along with diet, genetics, epidemic patterns, and other life-style factors, charcoal filters and tobacco processing may contribute as well (Hoffmann and Hoffmann, 1997). Traditional cellulose acetate filters treated with certain plasticizers can reduce some additional volatile and semivolatile compounds in smoke. The addition of charcoal particles in the filters reduces volatile smoke constituents such as ciliotoxic hydrogen cyanide, acetaldehyde, and acrolein. It can also reduce some volatile aromatic hydrocarbons, such as benzene and toluene, in the first puffs of a cigarette but becomes less effective in later puffs (NIH, 1996). Segmented filter systems, like charcoal-containing filters, provide a multitude of options. Charcoal, for instance, is available in a variety of activities depending on its surface area and pore volume. The amounts of material used in filters, filter length, and particulate removal efficiency can be adjusted (Davis and Nielsen, 1999). Since about 1968, many filter tips have been perforated with one or more lines of ventilation holes placed around the middle of the filter. Ventilation holes act slightly differently than the permeability ventilation provided by the cigarette paper. Filter tip ventilation is engineered to dilute the smoke as it travels through the cigarette and the filter. The result is an overall reduction in smoke and tar yields at standard smoking conditions to levels that filters, permeable papers, or processed tobaccos alone could not achieve. Approximately 80% of U.S. cigarettes have tar yields of 15 mg or less (FTC, 2000); most of these cigarettes have filter tip ventilations (Davis and Nielsen, 1999). The ventilation holes are inserted where smokers are likely to place their fingers or lips, which inhibits the intended use of the vents. Machine-generated smoke yield tests, however, position cigarettes so that the ventilation holes are exposed. Jenkins and colleagues conducted a study in 1982 comparing smoke yields between open and blocked tip ventilation. Their abbreviated results can be found in Table 4–1. The results showed that blocking the ventilated filters (VF) increased the tar, nicotine, and carbon monoxide to levels similar to that of regular filter cigarettes (F). There have been a few notable historic developments regarding novel cigarette filters of unproven efficacy. The Kent cigarette line produced cigarettes with a novel filter of coiled crepe paper with cotton fibers and crocidolite fibers in the 1950s. Crocidolite is a form of asbestos with fibers so thin that they could be arranged and used to trap particles as small as 1 µ (Longo et al., 1995). The so-called Micronite filter eliminated nearly
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction TABLE 4–1 Effect of Smoking Conditions (Blocked Tip Ventilation) on Smoke Yield (mg per cigarette±one standard deviation) Brand FTC (35 ml, 2 sec, 1 puff per minute) FTC+ (tip taped 35 ml, 2 sec, 1 puff per minute) Tar Yield VF-A 3.8±0.5 9.4±0.9 VF-C 2.9±0.6 7.6±0.9 VF-D 1.6±0.2 9.7±0.8 F-A 18.5±1.2 ND F-C 16.4±1.4 13.2±0.6 F-D 9.9±0.8 11.7±1.3 NF-A 22.5±1.0 21.3±1.5 NF-C 19.4±1.1 21.3±1.0 Nicotine Yield VF-A 0.40±0.05 0.72±0.05 VF-C 0.25±0.04 0.45±0.03 VF-D 0.19±0.05 0.62±0.07 F-A 1.09±0.07 ND F-C 0.94±0.02 0.71±0.06 F-D 0.61±0.02 0.68±0.10 NF-A 1.14±0.05 1.37±0.07 NF-C 1.13±0.13 1.6±0.23 Carbon Monoxide Yield VF-A 4.1±0.7 12.3±1.5 VF-C 2.1±0.2 8.7±1.2 VF-D 1.0±0.1 10.7±0.4 F-A 15.7±1.8 ND F-C 13.4±1.2 17.9±1.2 F-D 8.5±0.3 11.5±0.7 NF-A 11.3±1.0 12.8±2.7 NF-C 11.3±1.2 12.9±0.8 NOTE: F=filter; ND=not determined; NF=nonfilter; VF=ventilated filter; A,C,D=different brands. SOURCE: Modified from Jenkins et al., 1982 in NIH, 1996. twice as much tar and nicotine delivered to the smoker as any other standard brand of its time. Yet it failed in the marketplace due to the flavorless smoke and difficulty in drawing on it (Kluger, 1997). Ligget tobacco company experimented with adding palladium and magnesium nitrate to tobacco in efforts to decrease cancer rates in smokers. Preliminary tests on mice resulted in a 95% reduction in tumors compared to other brands. Little else is known about this innovation, because
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction research ended, reportedly due to litigation, in 1988 (Was a safer cigarette research snuffed, 1994). A new filter treatment called the “Wellstone Filter” has been developed. The cellulose acetate filter has been treated with a nonbiological compound that supposedly removes nearly 90% of tar and carcinogenic compounds while maintaining taste (Fisher, 2000). Patents are still pending. R.J. Reynolds also experimented with its own variation on filters. Reynolds created an extra corrugated carbon paper filter for the Winston Select EW brand. It was intended to reduce compounds linked to heart problems. The product was test marketed in Oklahoma City in 1996 (Feder, 1996). (This filter was known more commonly as the “carbon scrubber filter” to reduce free radicals linked to cardiovascular disease.) Other product modifications of interest for historical reasons include the Favor Smokeless Cigarette and Masterpiece Tobacs. The Favor Smokeless Cigarette was introduced in 1985 and was evaluated soon afterwards by the Food and Drug Administration (FDA), which determined the product to actually be a type of drug delivery device also known as a nicotine inhaler. The FDA removed it from the market. Masterpiece Tobacs is a chewing gum containing shreds of tobacco. Pinkerton Tobacco Company introduced it in 1987. This too was withdrawn from the market when the FDA determined the gum to be a food product with an unapproved food additive, tobacco (Fielding et al., 1998). Philip Morris also experimented with a modified cigarette with denicotinized tobacco called NEXT. NEXT had a tar yield of 9.3 mg but a nicotine yield of only 0.08 mg. Lacking the addictive component, this product was not successful on the market (Ferrence et al., 2000). Currently Available and Novel PREPs Modifications of Conventional Tobacco Products (See Table 4–2) A new curing process is being used for the production of tobacco with substantially reduced tobacco-specific nitrosamines (Star Scientific, 1999). The StarCure technology of Star Scientific (formally called Star Tobacco and Pharmaceutical Co.) has a modified and controlled curing process that has used microwaves to kill the bacteria that convert nitrogen-containing compounds into TSNAs. Star has recently stopped using this method and now uses curing barns that decrease microbial activity (Blackwell, 2000). Star Scientific has been using Virginia flue-cured Kentucky burley tobacco in its process. Star expected to bring to market products with only StarCure tobacco in late-2000. Other tobacco companies are reportedly working on methods for reducing or eliminating TSNAs from tobacco
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction TABLE 4–2 Tobacco Products Product Company Year Key Characteristics Kent Lorillard Co. 1950s Micronite filters Spectra Kinney 1980s Contained N bloctin, designed to block nitrosamine absorption in the lungs Favor Smokeless Cigarette 1985 Nicotine inhaler Premier Cigarette R.J.Reynolds 1987 Less combustion than conventional Masterpiece Tobacs Pinkerton 1987 Chewing gum with tobacco shreds NEXT Philip Morris 1989 Low-nicotine cigarette Eclipse Cigarette R.J.Reynolds 1996 Less combustion than conventional Winston Select R.J.Reynolds 1996 Extra corrugated carbon paper filter Accord Philip Morris 1998 Lower operating temperature than conventional cigarette and heat produced from electrical resistance Advance Star Scientific 2000 Low-nitrosamine cigarette (Fairclough, 2000). Brown and Williamson purchased two million pounds of low-nitrosamine tobacco from Star in 1999 and contracted for millions of additional pounds in 2000 (Fairclough, 2000; Star Scientific, 2000). Nitrosamines are still formed from these tobaccos upon combustion, but the noncombusted product contains very little or no TSNAs. Star Scientific has used this modified tobacco along with activated charcoal filters in a new line of cigarettes called Advance. Star hopes that by replacing traditional filters with the activated charcoal filter, it will reduce the levels of vapor-phase toxins (Star Scientific, 2000; Fairclough, 2000). Star Scientific gives smoking yields on its Web site and claims to have substantially lower TSNA, CO, and tar levels and similar nicotine levels compared to the average of three leading light brands (Star Scientific, 2000). A package insert for Advance cigarettes lists these findings as reported independently by the FTC and the Massachusetts Department of Public Health. Smokeless Tobacco Products Currently, most smokeless tobacco users in the United States use moist snuff. The 1999 National Household Survey on Drug Abuse reported that among the 66.8 million Americans who report current use of
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Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction responsibility, again without regulatory review. Manufacturers are under no regulatory obligation to conduct postmarketing epidemiological studies or to collect and report adverse events. The contrast between the regulatory systems for drugs or devices and for tobacco has been discussed by a number of authors (Henningfield, and Slade, 1998; O’Reilly, 1989; Page, 1998; Slade and Henningfield, 1998; Warner et al., 1997), who point out the paradox of a stringent regulatory system for exposure reduction products developed by the pharmaceutical industry and a weak regulatory system for exposure reduction products developed by tobacco manufacturers. Table 4–8 illustrates the problem. TABLE 4–8 Comparison of Two Nicotine Inhalers Feature Eclipse (tobacco company) Nicotrol Inhaler (pharmaceutical company) Operation Heat source volatizes nicotine and glycerol, and scorches tobacco Ambient air passing through nicotine reservoir volatizes nicotine Dose Mimics cigarettes (lung delivery of nicotine) Similar to low Nicorette dose (buccal delivery of nicotine) Projected abuse liability High Low Contaminants High CO, acrolein, “soot,” and other contaminants Not allowed Claims or indications Reduced delivery (unproven to FDA) Smoking cessation (FDA-approved studies) Intent Cause and sustain dependence Treat dependence Cost More than $3.00 per pack of 20 ($0.15 each) $55.00 per pack of 42 ($1.30 each) Modification oversight Modified to be more palatable (and more toxic) without approval Any modification requires FDA approval Premarketing approval data None submitted to FDA Conventional new drug application submission and FDA approval Availability Over-the-counter Prescription only SOURCE: Slade and Henningfield, 1998. Reprinted with permission of the Food and Drug Law Institute.
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