Toxicology

 
ALCS uses toxicological principles and established regulatory guidelines to ensure that product designs and components, packaging, manufacturing materials and processes, are acceptable for intended use.
We evaluate the suitability for use in products of new or modified product components, packaging, manufacturing materials and processes. This evaluation follows a scientifically sound process of toxicological assessment. In this section, you will find ALCS's toxicological evaluation guidelines for cigarette and smokeless tobacco products, as well as information on our toxicological evaluation and review of some of the major ingredients used in our products.


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Guidelines for toxicological evaluation​s
Cigarette Products
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Cigarette Products
​​​A toxicological evaluation serves as the mechanism for providing guidance regarding the suitability for use of product components, packaging or manufacturing materials, processes, integrated technologies and integrated product designs.
Guideline for the Toxicological Evaluation of Cigarette Products
ALCS's Product Integrity Toxicological Evaluation Guideline: Cigarette Products and an overarching decision-making flow framework Product Integrity - Toxicological Evaluation Framework Overview describe the basic approaches used in this evaluation.
The purpose of the toxicological evaluation is to provide a basis for assessing whether the potential for product changes or new designs increase the inherent toxicity of cigarette smoke using established non-clinical toxicology testing methods.
Toxicological Evaluation of Cigarette Ingredients
Ingredients have been used in the manufacture of certain cigarettes to complement the subjective characteristics of the different tobacco types, and provide the distinctive flavors, tastes, and aromas associated with different cigarette products. Toxicological testing provides a basis for assessing the potential for the ingredient(s) to increase the inherent toxicity of cigarette smoke.
In a multi-year cigarette ingredient testing program, we utilized a set of chemical and biological endpoints frequently used in toxicity testing. We used a tiered approach where progressively more in-depth chemical analyses and biological assays were performed as the potential intended use level of the ingredient increased. The data were collected by qualified testing laboratories using validated and controlled testing methods.
We evaluated a total of 95 potential cigarette ingredients and published the results in 11 publications contained in a special issue of Inhalation Toxicology in 2011. In summary, when assessed against the variability of assay methodology, natural agricultural change and manufacturing control, the ingredients studied demonstrated little relevant influence on the inherent toxicity associated with mainstream cigarette smoke.
Toxicological Information on Cigarette Ingredients
Over the years, we have compiled toxicological information on cigarette ingredients, which is shown in this table​ for several of the major ingredients that we use in Philip Morris USA’s cigarette products. For each ingredient you will find a wide array of scientific information, including biological and chemical data relating to the use of these ingredients in tobacco and food products, data on the toxicity of the ingredient (when applied to tobacco as part of a cigarette) and combustion and pyrolysis data.​
​Smokeless Products
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Smokeless Products
​​​A toxicological evaluation serves as the mechanism for providing guidance regarding the suitability for use of product components, packaging or manufacturing materials, processes, integrated technologies and integrated product designs
Guideline for the Toxicological Evaluation of Smokeless Tobacco Products
 
The purpose of the toxicological evaluation is to provide a reasonable certainty that the product or product design will not increase the inherent risk beyond that recognized for currently available marketed products (e.g. similar smokeless tobacco products).
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