FINDING OF NO SIGNIFICANT IMPACT FOR 

Product Market Authorization Orders for 

General Loose General Dry Mint Portion Original Mini 

General Portion Original Large General Classic Blend Portion White Large 

General Mint Portion White Large General Nordic Mint Portion White Large 

General Portion White Large General Wintergreen Portion White Large 

Manufactured by Swedish Match North America, Inc. 

The Center for Tobacco Products of the Food and Drug Administration (FDA) has carefully 

considered the potential environmental impact of these actions and has concluded that these 

actions will not have a significant effect on the quality of the human environment. Therefore, an 

environmental impact statement is not required. 

Swedish Match North America, Inc. wishes to introduce eight new snus products into interstate 

commerce for commercial distribution in the United States (U.S.) and submitted to FDA the 

premarket tobacco product (PMT) applications to obtain market authorizations pursuant to 

Section 910(b) of the FD&C Act. 

The agency prepared the programmatic environmental assessment (PEA) , dated October 8, 

2015, under the Council on Environmental Quality's regulations (40 CFR 1500-1508) 

implementing the National Environmental Policy Act to support the finding of no significant 

impact (FONSI). The evidence supporting this finding is contained in the attached PEA, which is 

available to the public upon request. 

The PEA provides an environmental effect assessment due to manufacturing, use, and disposal 

after use of the new products The PEA also provides analysis on energy and resource use as a 

result of marketing the new products. The new products are manufactured in Sweden and used 

and disposed of in the U.S. 

To evaluate the environmental introduction of the proposed action due to manufacturing of the 

new products in Sweden, the agency utilized historic data from 2009-2014 to forecast the 

amount of smokeless tobacco products imported to the U.S. from Sweden. We found that the 

projected market volumes of the new products are a small portion of the U.S. import forecast of 

snuff tobacco from Sweden. In addition, the new products are expected to replace the currently 

marketed products with the same names. The agency does not foresee any additional 

emissions to be released into the environment due to their manufacturing. Therefore, the 

introduction of released substances due to manufacturing the new products is negligible from 

the environmental viewpoint. 

To evaluate the environmental introduction of the proposed action due to use of the new 

products, the agency utilized historic data of use in 2005-2014 from U.S. Department of 

Treasury Alcohol and Tobacco Tax and Trade Bureau statistics to forecast the amount of use of 

smokeless tobacco products and snuff. We found that the projected market volumes of the new 

products are a fraction of the forecasted use of smokeless products or snuff tobacco in the U.S. 

As previously noted, the new products are expected to replace currently marketed products with 
the same names. The agency does not foresee any additional materials to be released into the 

environment due to their use. Therefore, the introduction of released substances due to use of 

the new products is negligible from the environmental viewpoint. 

The agency believes that the disposal of the new products resembles the disposal conditions of 

the current snus products and any other smokeless tobacco products that are being marketed. 

The waste generated as a result of use of the products will be released to the environment, 

transferred to publically owned treatment works, and disposed of in landfills in the same manner 

as the waste generated from any other smokeless tobacco products used in the U.S. The 

amounts of projected tobacco waste and packaging materials, including paper and plastics, due 

to use and disposal of the new products is a minute fraction of the forecasted tobacco product 

waste generated due to use of smokeless tobacco products. Also, it is a negligible fraction of 

municipal solid waste generated in the U.S. based on information presented in US 

Environmental Protection Agency’s Report “Advancing Sustainable Materials Management: 

Facts and Figures 2013”. Therefore, the introduction of released substances due to disposal 

after use of the new products is negligible from the environmental viewpoint. 

The market volume projections for the new products are a negligible fraction of the total 

smokeless tobacco products sold in the U.S. Furthermore, the new products will replace the 

currently marketed products with the same names. The agency does not anticipate the market 

volume for all smokeless tobacco products to be changed noticeably based on the provided 

information. Consequently, the additional use of resources and energy due to marketing the new 

products is also negligible. 

Because the environmental introduction is miniscule and the additional use of resources and 

energy is negligible, no significant environmental impacts are expected from marketing the new 

products. 

Digitally signed by Kimberly A. Benson -S 

Date: 2015.10.08 10:17:33 -04'00' Approved by 

Kimberly Benson, Ph.D. 

Director 

Division of Nonclinical Science 

Office of Science 

Center for Tobacco Products 

Food and Drug Administration