The US Food and Drug Administration issued a notice in the Federal Register yesterday, July 30, 2012 which seeks comments on proposed collection of Hazardous and Potentially Hazardous Constituents (“HPHCs”) in tobacco products, noting a proposal for data collection was sent to the Office of Management and Budget.

This notice gives new insights into FDA’s current thinking on testing and reporting HPHCs, and suggests strongly that FDA’s intent is to follow the testing regime described in the Draft Guidance issued March 30, 2012, particularly as to timing.  Yesterday’s notice in the Federal Register includes FDA’s current intention to exercise enforcement discretion for manufacturers who test for 20 rather than 93 constituents at this time, and adds that small tobacco manufacturers were given an additional three months, until December 22, 2012 to comply.  No Final Guidance has been issued by FDA.

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