Warning: Delays Imminent For Clearance Of Food Packaging Materials

Date: May 01, 2007

The Food and Drug Administration is threatening-again-to end its highly effective food-contact notification (FCN) program.The U.S. Department of Health and Human Services has released its fiscal year 2008 budget proposal for the FDA. Just like last year's budget proposal (which was successfully contested), the FY2008 budget would eliminate funding for the food-contact notification program as the mechanism for clearing new packaging materials and new uses of such materials with food. Instead, the proposal suggests that, beginning in October 2007 (the start of the 2008 fiscal year), the agency should revert back to clearing such materials through the lengthy food-additive petition process.

Memories of yesterdays

A food-additive petition constitutes a request to the FDA to amend the food-additive regulations (21 C.F.R. Part 170 et seq.). In the past, the FDA's review of such petitions has typically taken years to complete. The same can likely be expected in the future if this again becomes the prevalent mechanism available to clear a food-contact substance.

In contrast, the FCN program, which has processed more than 500 FCNs since its implementation in January 2000, has been heralded by industry for its efficiency and effectiveness. It allows new food-contact substances to be marketed and used as soon as 120 days from the date of filing.

Last year, industry was successful in convincing the Congress to reinstate funding for the FCN program (both the House and Senate agreed to do so). However, the Senate failed to pass a final bill before the end of the fiscal year. So funding was provided by way of a continuing resolution, which essentially preserves the status quo.

The Administration's proposal

The Administration is proposing a fiscal year 2008 budget for the FDA of $2.1 billion; this is a 5.3% increase over the FY2007 request. The request includes an increase for the FDA's Center for Food Safety and Applied Nutrition (CFSAN) of about $17 million, a 3.8% increase over the FY2007 request, and a 3.3% increase over the amount ($14.5 million) provided for CFSAN under the FY2007 continuing resolution.

Even though the CFSAN stands to receive more money in the latest budget proposal, the FDA is calling for a "strategic redeployment" of funds from the FCN program to higher priority programs, such as targeted food defense research, and improvements to food surveillance capabilities and crisis management.

Oddly enough, the FY2008 funding for CFSAN will require a reduction of 72 full-time staff versus the FY2006 budget. More work and fewer people will undoubtedly mean even longer time lags. Industry is once again working hard to thwart this latest attempt.

The success of the FCN program is not in dispute. The question is whether you can afford to do without it. If you don't think so, now is the time to let your representatives know.

Used with permission. Copyright FOOD & DRUG PACKAGING, May, 2007.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com