Post Market Compliance for Nicotine Products and NGPs

Strategies to Minimize Risk and Protect Public Health

Post market compliance responsibilities for manufacturers of consumer next generation nicotine products (NGPs) and medicinal nicotine replacement therapies (NRT) in the U.S. are complex. They require multidisciplinary teams within your business to collaborate on a quality control and testing strategy that gathers, analyzes, and reports data around various critical areas of regulatory concern, such as product performance and user behavior. The requirement can also extend to record-keeping on marketing messaging, advertising, and retail execution.

This means your nicotine product must be monitored throughout its entire life cycle, and appropriate strategies must be implemented to minimize the risk to users and protect public health.

Building a Post Market Compliance Strategy for the U.S.

Post market compliance is required in the U.S. for medicinal NRT and consumer NGPs with a PMTA marketing granted order.

Building an effective post market compliance strategy for the lifetime of your nicotine product will require a comprehensive quality control release testing program, the monitoring of yellow card adverse events and suspected adverse events, and conducting behavioral studies to ensure vulnerable populations are not using your product. It may also be necessary to monitor and keep a record of marketing and advertising activities.

Our scientific and regulatory consultants have extensive experience across consumer NGPs and medicinal NRT. They can advise on all aspects of post market compliance relating to nicotine delivery products in the U.S.

We recommend you consider compliance requirements at the early stage of product design and concept ideation to ensure your nicotine product has been developed with its future ongoing compliance requirements in mind.

Post Market Product Changes

Expert regulatory and scientific consultancy on planned changes to product speciﬁcations or manufacturing processes, supported by the creation of an impact assessment report.

For the PMTA regulatory pathway, product changes are not allowed. A new PMTA or an exemption from PMTA is required.

Post Market Product User Surveillance Studies

Design and management of post market consumer studies based on FDA feedback, and full analysis of ongoing and completed studies, including the compilation of summaries, and the submission of ﬁnal reports to regulators.

Clinical and Non-clinical Literature Reviews

A full scientiﬁc literature review of available literature, including new in-vitro, in-vivo, and clinical data across published peer-reviewed journals and scientiﬁc databases that may be relevant to your product.

Quality Control Release Testing

Quality Control Release Testing in a cutting-edge laboratory specifically designed to support nicotine delivery projects and their regulatory compliance needs.

Product Labelling

Review of labelling change requirements and reporting changes to regulators.

Adverse Events

The analysis of adverse event data from individual consumer experiences to identify societal trends related to the use/misuse of your product. Compilation of data, impact assessments and report writing for submission to regulatory authorities.

Appropriate for the Protection of Public Health (APPH)

The preparation of ongoing assessments that demonstrate whether the rationale to support APPH is still appropriate considering new data, adverse events, and sales information.

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.

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

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PMTA Guide For NGP businesses

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TRPR (TPD) Vs MAA Comparison Chart

Looking to take your ENDS products to new markets? Compare the differences and get the pros and cons between products with EU Tobacco Products Directive (TPD) notification and products with an EU medicinal product license in our free download.

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Nicotine Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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Post Market Compliance
for Nicotine Products

Maintaining Regulatory Compliance in the U.S. by Ensuring Ongoing Benefit to Public Health

Strategies to Minimize Risk and Protect Public Health

Building a Post Market Compliance Strategy for the U.S.