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President's Budget Proposal Would End FCN Program

Date: Feb 07, 2006

On February 6, 2006, the Administration released the president's budget for Fiscal Year 2007 for the Food and Drug Administration. In a major blow to the packaging industry, the president is proposing that the Food Contact Notification program be discontinued.

In the consolidated narrative of the FDA 2007 budget, on page four, under the heading "Performance Analysis," the FDA states:

. . . the FDA Modernization Act (FDAMA) established a notification program for food additives that are food contact substances (e.g., packaging materials). Under the provisions of this notification, a food contact substance may be marketed 120 days after notification unless the agency objects. As part of the FY 2007 strategic redeployment of resources to fund higher priority FDA programs (e.g., food defense and pandemic influenza), this program will be discontinued.
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Keller and Heckman LLP is working closely with The Society of the Plastics Industry, Inc. (SPI) to form a coalition of companies and trade associations to lobby Congress and the Administration to reinstate funding for the FCN program. If you are interested in updates on the coalition's activities, please let us know immediately and we will get you the appropriate details once available.

Since its implementation in January 2000, over 400 FCNs have become effective. The program has been extraordinarily successful, as it has cut FDA review times from a standard of two to five years, sometimes longer (with food additive petitions), to 120 days for FCNs.

If the budget proposal is adopted unchanged, the only available option to clear food contact substances will once again be the filing of food additive petitions. Without the additional FDA resources available to review such filings, the years-long delays companies experienced in seeking amendment of the food additive regulations are unfortunately assured. Working with SPI, we will devote all of our available resources to prevent such an outcome.

For further details on the budget proposal, please feel free to call any of your contacts here at Keller and Heckman. Again, we welcome your help; details on participating in the industry coalition will be provided later.

Jerome H. Heckman, Keller and Heckman LLP