The U.S. Food & Drug Administration has proposed to totally eliminate an invaluable engine of packaging innovation and business. If President Bush's budget gets passed as proposed later this year, packagers will lose the Food Contact Notification (FCN) program, leaving only the laborious Food Additive Petition process for gaining FDA approval of new uses.
The FCN program has been a boon to packaging research and development, a government program that combines efficiency, speed and protection of the public health in just the way one might wish. Its core advantage over the pre-existing Food Additive Petition process is that it imposes a 120-day deadline on FDA review of FCNs. This four-month review is short, and it is predictable, which may be even more important. With it, companies can file FCNs with FDA and know with a high degree of confidence that the substance being reviewed will be marketable just four months later. Armed with this knowledge, companies can budget, plan, project and sell.
Before the FCN program was instituted, the law called for FDA to review Food Additive Petitions in six months. If, because of a lack of staff or any other reason, FDA didn't get the review done in time—and frequently they didn't—the filer had no practical recourse. They just had to continue waiting, not knowing when the review would be completed. Just try sketching out a business plan for your division for the next quarter or next year with no idea whether you'll be selling your new product. The unpredictable timing can kill new product development before it begins.
Another advantage of an FDA-cleared FCN is that it is exclusive to the submitter. By contrast, the results of a Food Additive Petition become a published regulation.
Since the program began in 2000, FDA has reviewed and cleared about 540 FCNs (and counting) for all sorts of packaging materials and components. That's a lot of product innovations. These innovations have led to enhanced food-product protection, distribution and convenience. They have also stimulated sales, revenues and jobs for the packaging and food companies that use them.
The FCN program is, in short, a commerce creator. It represents a clearing away of bureaucratic obstacles to the advantage of consumers and companies alike, even as it maintains the necessary protections of the public health. To eliminate it would cause colossal injury to the packaging industry.
An FDA official with detailed knowledge on the background of the proposal, but who requests anonymity, offers some useful insights.
According to the official, the Bush administration told FDA what its new priorities should be, and FDA translated those priorities into its budget proposals. In doing so, FDA tried to focus on areas that have the least impact on public health, says the official. That means that funds will be moved into programs that enhance safety and, in turn, moved out of programs that less directly implicate safety. Those in the latter category include the FCN program, but also research, cosmetics, dietary supplements and other fields. The FCN program has long been associated with relatively low-risk exposures to small amounts of potentially harmful substances, in contrast with, for example, direct food additives and food ingredients, to which people are usually exposed at higher levels.
Under the proposed budget, FDA will pick up more total full-time-equivalent employees and an increase of almost $71 million dollars to bring its total budget of government funds to about $1.55 billion (plus an additional $402 million in "user fees" paid by, for example, filers of new drug applications).
But the emphasis in this new budget is on security, and in the process of rejiggering priorities, the FCN program will be cut, as FDA's food division, the Center for Food Safety and Applied Nutrition, shrinks a bit overall.
It's not that FDA officials don't like the FCN program, says the official. They like it fine, and they know that industry likes it, as well. But the priorities are shifting away from programs "with the least impact on public health, and this is one," he says.
What will be left is the traditional Food Additive Petition process, which the official acknowledges is "slower and more cumbersome, but still protects the public health."
Has anyone floated proposals for streamlining food-contact substance reviews, even if the formal context is going to be the Food Additive Petition process? "We're open to any ideas people have for helping us achieve efficiency," the official says.
But don't wait until the budget gets finalized with the elimination of FCNs built in. Now is the time to contact your representatives in the U.S. Senate and Congress. Tell them of the value of this program to the packaging industries: how it clears the path for product innovation and R&D, how it creates jobs and revenue for U.S. companies and how losing it would mean a loss of all those advantages. Tell them in numbers if you can, quantifying in dollars the sales attributable to materials that came on the market under the FCN program, or the numbers of employees related to the materials or the capital improvements your company put in place to make or convert food-contact substances cleared onto the market under the program.
The FCN program is that rare bureaucratic program that was crafted with good sense, and now the packaging industry needs to fight to keep it.