CSUR is a specialist research agency assisting companies with the behavioural research required to obtain a marketing authorization through the Pre-Market Tobacco Product Application (PMTA) process.

CSUR is also expert in behavioural research to support applications for companies seeking to market new tobacco products with modified risk and/or modified exposure messaging through the MRTPA pathway.

Centre for Substance Use Research Ltd is a multi-disciplinary research agency providing behavioural science support to companies submitting applications for PMTA, MRTP and TPD approval.

What is PMTA?
In May 2016, the U.S. Food and Drug Administration (FDA), through its Center for Tobacco Products (CTP), finalized a rule – referred to as the ‘Final Deeming Rule’ – that deemed all products meeting the statutory definition of “tobacco product” in section 70 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to be subject to chapter IX of the FD&C Act. This meant that in order for any new tobacco product to be authorized for marketing a Pre-Market Tobacco Application (PMTA) must be submitted to FDA. A PMTA must provide substantial scientific evidence to demonstrate a product is ‘appropriate for the protection of public health’ in order to be granted a marketing authorization.

The Centre for Substance Use Research (CSUR) is expert in the design, conduct and reporting of the behavioral studies advised by the FDA in demonstrating a products ‘appropriateness’ by assessing the risks and benefits of a product on the population as a whole and the risk perceptions and use intentions in relation to the product.

You can find out more info here.

What is MRTP?
In order to list a tobacco product as a “Modified Risk Tobacco Product” manufacturers/brands need to provide scientific evidence to substantiate their modified risk claims or modified exposure claims. CSUR is expert in the behavioural research in support of an MRTP application.