Abstract: An environmental assessment is required for all new tobacco products that apply for market authorization in the USA. This assessment includes determining the impact of manufacturing, use, and disposal of the product on the environment. A new category of pouched tobacco products generally known as modern oral nicotine products has become popular. They do not contain any tobacco leaf material and are generally made with cellulose, binders, flavors, and nicotine. The granular material is enclosed in a fleece pouch, similar to a tea bag, also usually cellulose based. The consumer places the pouch between the lip and gum for buccal absorption of the nicotine which releases through the pouch membrane over time. After the pouch is depleted, the consumer is instructed to dispose of the used pouch in the trash. Reasonable worst case disposal scenarios were modeled to evaluate if a used pouch was to be disposed of in publicly owned wastewater treatment systems, in home septic systems, or as litter on the ground. Additional potential releases of nicotine to the environment during product use from human excretion were also modeled. The FDA approach established for human drugs and biologics was applied to quantify the anticipated effect of residual nicotine in the pouch on the environment. The calculations compared the Expected Introduction Concentration to the established de minimis concentration of 1 microgram per liter or 1 part per billion. The results of the various worst case scenario calculations showed the estimated nicotine concentrations are not expected to exceed the de minimis threshold under any of the scenarios and therefore the use and disposal of the product is not likely to significantly impact the environment.
Affiliations: Chemular, Inc, Hudson, MI