The World Health Organization (WHO) recently published its Global Report on Trends in Prevalence of Tobacco Use 2000-2030.
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.
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-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).
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.
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.
Pharmaceutical Services - Extractables and LeachablesThe evaluation of extractables and leachables (E&L) is an essential component of the pharmaceutical development process.
Toxicology Advice and Consultancy ServicesOur team of in-house toxicologists reviews and evaluates toxicological data on a wide range of chemicals to produce independent expert opinions on risk assessment. We then advise on the strategies to mitigate or reduce those risks to protect corporate reputation and public health.
Industry Insight and Expert Opinion
Learn more about our activities and gain insight from our scientific and regulatory experts
The US Food and Drug Administration (FDA) has just announced an extension of its review of Premarket Tobacco Product Applications (PMTAs), as ....
On January 29, 2024, Prime Minister Rishi Sunak announced that disposable vapes would be banned in the UK as part of the Government’s plan to tackle ....