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FDA's Mark Hepp Reviews 10 years of FCN Program at Keller & Heckman Seminar

Nov 17, 2009

Ten years ago, the Food and Drug Administration Reform Act of 1997 (FDAMA) authorized the Food Contact Notification (FCN) system. Since the program was implemented in January 2000, the Food and Drug Administration (FDA) has received 879 FCNs, reported Mark Hepp, Consumer Safety Officer, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), FDA. Speaking at Keller and Heckman's 10 annual Food Packaging Law Seminar, on Oct. 21, 2009, Hepp said that the first 66 FCNs to clear had originally been submitted as Food Additive Petitions (FAP). The largest number of FCNs cleared in a calendar year occurred in 2000 because of the 66 FAPs, followed by 2006. The number of FCNs submitted began to decline in 2007 due to the economy, explained Hepp. (Click here to view the slides from Hepp's presentation, which include a chart of FCNs submissions.)

The Division of Food Contact Substances Notifications (DFCN), in FDA's Office of Food Additive Safety, has also participated in 802 pre-submission consultations since the FCN program began. Additional DFCN responsibilities include evaluating Threshold of Regulation (TOR) submissions, FAPs for food contact substances, and responding to requests for information under the Freedom of Information Act. Since the FCN program began, FDA has not received any FAPs for food contact substances and the number of TOR submissions have declined, Hepp said. He attributed the reduction in TOR submissions to the fact that FDA does not have to response to them as quickly as it does to FCNs.

Hepp also discussed FDA's current Post-Market Evaluation of Bisphenol A (BPA). The agency will announce the results of its reassessment of BPA's safety on Nov. 30, 2009. At that time, Hepp explained, if the safety standard is met, FDA will explain the basis of finding, and advise; and if the safety standard is not met, FDA will announced plans to initiate rulemaking. (See PackagingLaw.com articles: FDA to Review Safety of BPA and Additional BPA Studies Planned, FDA Tells Science Board for background information on the review.) FDA is also conducting post-market evaluations of perfluoro compounds, siloxanes, and phthalates. Hepp advised consulting with FDA before preparing an FCN relating to these classes of compounds.