FDA Posts Programmatic Environmental Assessment for Nicotine Pouches and Additional “Other” Nicotine Products

May 21, 2026

Today, FDA posted a programmatic environmental assessment related to the agency’s review of premarket tobacco product applications (PMTAs) for new tobacco products in the “other” category, which includes nicotine pouches, lozenges, discs, tablets, and gums, as well as dissolvable tobacco products and other nicotine infused products (but specifically excludes smokeless tobacco products such as dip, snuff, snus, and chewing tobacco).

As part of the FDA’s review of applications for new tobacco products, the agency is required to evaluate the environmental effects of authorizing the marketing of a new tobacco product. This programmatic environmental assessment summarizes the existing scientific data on the environmental effects of the use and disposal of new tobacco products categorized by the FDA as “other.” In general, the assessment found that the environmental effects are minimal because these products do not result in airborne emissions during use, thus reducing or eliminating secondhand and thirdhand exposure to bystanders. Additionally, the waste from these products contains few harmful chemicals that can leach into or persist in the environment, and bioaccumulate.

As part of the FDA’s commitment to transparency, the agency is posting this assessment to inform the applicants and the public, and it may be cited by FDA staff conducting scientific reviews. 

While this review is applicable to products in the “other” category broadly, the FDA’s review of tobacco product applications is based on the specific facts presented in each application. When the FDA authorizes a new tobacco product, the agency typically posts several documents associated with the new product, including the Environmental Assessment and either a Finding of No Significant Impact (FONSI) or an Environmental Impact Statement.  

For more resources on Environmental Assessments and other topics, please visit Regulatory Science Memoranda on FDA’s Review of Tobacco Product Applications.