Zero Funding for FCN Program?
- Published: February 28, 2006, By Sheila A. Millar, Attorney-at-Law, Keller & Heckman, Washington, DC
Legal Briefs
In a significant step back for industry, the proposed budget for the US government’s 2007 fiscal year (FY) would abolish the federal Food Contact Notification (FCN) program of the Food and Drug Administration (FDA).
The FCN program was authorized with the passage of the FDA Modernization Act of 1997 (implemented with respect to food contact substances in 2000) and has become a major avenue for streamlined approvals for food contact substances. The FY 2007 budget released by the administration February 6, however, eliminates funding for the FCN program as “part of the FY 2007 strategic redeployment of resources to fund higher priority FDA programs (e.g., food defense and pandemic influenza)….”
Abolition of the FCN program could presage a return to more limited and time-consuming approvals, delaying introduction of new packaging options into the market. Members of the converting industry should be very concerned about the proposal and should be considering strategies in response. The concern, of course, derives from the fact that Section 201 of the Federal Food, Drug and Cosmetic Act (FDCA) defines food additives as:
If the FCN approval program is discontinued as proposed in the budget, the primary vehicle for food additive approvals will be a return to the old system of filing a food additive petition to obtain a regulatory clearance.
The FCN program has succeeded in offering manufacturers a much faster way to gain approvals of substances intended for use in packaging. Since 2000, when the FCN program went into effect, more than 400 FCNs have become effective.
The FCN program allows the substance covered in the FCN to be marketed in 120 days unless FDA objects. Unfortunately, the food additive petition process is lengthy and cumbersome, with approvals often taking two to five years, or even longer. In addition, there are attendant added costs as a result of the delay, including lost revenues from delayed market introduction.
Further, FCNs are proprietary to the notifier and its customers, while food additive regulations, once adopted, apply to any company that can make the product in compliance with the regulation.
While there is no denying the current national budgetary pressures and deep concerns about maintaining the safety of the nation’s food supply, protecting against bioterrorism, and preparing for a possible pandemic flu situation, the entire packaging industry will be widely and adversely affected should the FCN program be eliminated.
Converting industry members, their suppliers, and their customers should consider the implications to their businesses and become engaged in the debate.
Sheila A. Millar, a partner with Keller and Heckman LLP, counsels both corporate and association clients. Contact her at 202/434-4143; This email address is being protected from spambots. You need JavaScript enabled to view it.; packaginglaw.com.
