Regulatory Submission

Table of Contents

Pre Market Tobacco Application

Under section 910(b) of the U.S. Federal Food Drug and Cosmetic Act manufacturers of novel tobacco products, including ENDS, are required to seek a marketing authorisation from the Food and Drug Administration to enable the legal sale of their products. As part of the Pre-Market Tobacco Application process manufacturers of these products are required to support research on the basis of which the FDA will determine whether the products being assessed have the capacity to significantly reduce tobacco related disease to individuals and whether the sale of these products will benefit the health of the population as a whole.

Modified Risk Tobacco Product

The U.S. Food and Drug Administration has also instituted a Modified Risk Tobacco Product Application process through which the FDA can assess the accuracy and likely impact of any “reduced harm” claims manufacturers of novel tobacco products can make with respect to their products.

Behavioural Research Program

CSURES are expert in research program design and execution to meet the behavioural research requirements set out by regulators in both PMTA and MRTP submission:

  • Assessing the risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as non-users.
  • Assessing the likelihood with which people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available.
  • Assessing whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available.
  • Assessing the appeal of new tobacco products including the conclusions consumers and potential consumers might draw from the packaging and messaging on novel tobacco products.

Post Market Surveilence

The U.S. Food and Drug Administration has also instituted a Modified Risk Tobacco Product Application process through which the FDA can assess the accuracy and likely impact of any “reduced harm” claims manufacturers of novel tobacco products can make with respect to their products.

Regulatory Contacts

CSURES staff have had contact with FDA CDC with regard to optimal research designs to assess the public health impact of novel tobacco products, ensuring that all research design is closely aligned with the regulatory submission requirement.

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