The Food and Drug Administration (FDA) has recently opened a new docket for public comment on Harmful and Potentially Harmful Constituents (HPHCs)  in Tobacco Products and Tobacco Smoke. The FDA is requesting scientific and other information to assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list). The docket will be open until October 11, 2011.

In addition, the FDA has also opened a docket for public comment based on the topics addressed at its  recent  public workshop on Modified Risk Tobacco Product (MRTP) Applications, which was held on August 25 and 26. The workshop was targeted at  scientific and medical experts and other interested participants from academia, public health organizations, federal, state and local government agencies, consumer groups, and the tobacco industry.  The workshop featured five moderated panel discussions on the following topics:

  • Assessing the Potential Effects of MRTPs on Individuals and Populations
    • Benefit to Individual Tobacco Users
    • Impact on the Health of the Population as a Whole
  • Comparisons of MRTPs to other Tobacco Products
  • Modified Risk Claims for Reduced Substance Exposure
  • Consumer Perceptions of MRTPs
  • Post-Market Surveillance and Studies of Commercially Marketed MRTPs

This docket will be open to receive comments on MRTPs until September 23, 2011.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.