The Food and Drug Administration (“FDA”) issued on March 30, 2012 a Draft Guidance (attached) which contains requirements for Reporting Harmful and Potentially Harmful Constituents (“HPHC”) in Tobacco Products and Tobacco Smoke. FDA is enforcing the HPHCs testing and reporting requirements for cigarettes, smokeless and RYO, but not for components sold for incorporation into finished tobacco products.

FDA’s Guidance requires that each manufacturer or importer test and report HPHCs in each tobacco product marketed prior to June 22, 2012 for an abbreviated list of HPHCs, by September 22, 2012, or by December 22, 2012 for small tobacco manufacturers (less than 350 employees). If a manufacturer, importer or agent timely files the required information for all brands and sub brands, then FDA says it will not require the company to test its products for the entire list of 96 HPHCs. The abbreviated list includes 18 HPHCs in cigarette smoke, 9 HPHCs in smokeless, and 6 HPHCs in RYO. This leaves open the door for later requiring the full list of testing

The HPHCs in New Products marketed after June 22, 2012, or changed products, shall be reported at least 90 days prior to introduction into the market. If the product change is only made to the label and does not alter quantities of HPHCs in the product or smoke, then additional testing is not required. If the package size will not affect quantities of HPHCs, each package size does not have to be tested.

The Draft is silent about extending the exemptions provided for new products marketed after June 22, 2012 and changed products (concerning package labeling and package size mentioned above), thus manufacturers do not appear to receive this break for the initial round of testing and reporting required for product marketed before June 22, 2012.

Contributor: Nancyellen Keane

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