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Environmental Assessments
for PMTA and MRTP

Ensuring your Premarket Tobacco Product Application (PMTA) and Modified Risk Tobacco Product (MRTP) submissions meet National Environmental Policy Act (NEPA) requirements.   

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Robust National Environmental Policy Act (NEPA) Environmental Assessments are an essential part of a PMTA  or MRTP application that addresses the potential environmental impacts of the manufacture, use, and disposal of Electronic Nicotine Delivery Systems (ENDS) and oral nicotine products. Separate Environmental Assessments are required to cover the device, e-liquid formulation, cartridges, container, and packaging.

Read more about NEPA Environmental Assessments. 

Our U.S.-based environmental assessment consultants have extensive experience working with major global brands on PMTA and MRTP submissions. With over 22 years of interdisciplinary scientific professional experience, they specialize in environmental impact analysis, toxicology, risk assessment, environmental chemistry, environmental microbiology, and regulatory permitting and compliance.

Which NGPs require a NEPA Environmental Assessment?

Any ENDS or oral nicotine product that requires a PMTA or MRTP marketing authorization for sale in the U.S. requires a NEPA Environmental Assessment as part of the application. 

  • E-liquids
  • E-cigarettes (devices or device/liquid combinations) 
  • Heated tobacco products (devices and consumables) 
  • Oral nicotine products (pouches, tablets, gum, lozenges, toothpicks)

Each stock-keeping unit (SKU) requires an individual Environmental Assessment. The absence of an EA or an inadequate EA will result in either a ‘Refuse to accept’ or a ‘Refuse to file’ (RTA/RTF) decision by the Food and Drug Administration (FDA).


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Steps in Compiling an Environmental Assessment

  • The initial stage of an Environmental Assessment is sharing a well-defined project description, including the purpose and need.
  • The product supply chain should also be documented, including, but not limited to, details of manufacturing and shipping to retail entities for FDA-approved products destined for sale in the U.S.
  • The environmental and social resources should be characterized around manufacturing facilities to provide an understanding of the baseline conditions, or in NEPA language, the “affected environment.” A project's potential impacts will be evaluated based on positive or negative changes to those baseline conditions.
  • An Environmental Assessment will be appropriate for submission if it’s determined that impacts from the proposed project will not be significant or FDA concludes a finding of no significant impacts (FONSI).
  • Mitigation measures may be recommended if impacts are anticipated, which can reduce impacts below a significance threshold.

Speak to an expert 

Arrange a meeting with our NEPA EA experts to discuss your project and learn how we can help bring your Next Generation Nicotine Delivery Product to market in the U.S.

 

Speak to an expert

Nicotine Consultancy Services Resources 

Learn more about how we can help bring your nicotine delivery product to market through our scientific and regulatory consultancy services.

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