Pre-market notification

Last year's FDA reform bill replaced the old pre-market approval process with pre-market notification (PMN), under which FDA has 120 days to require a full review of a new packaging material or else it may proceed to market. Meanwhile, House and Senate Appropriations subcommittees with jurisdiction over FDA's budget have held hearings on the agency's FY '99 budget and are working out the final figures. The Society for the Plastics Industry has been working with the subcommittees to ensure the $1.5 million authorized in the FDA reform bill to implement the new PMN program is actually appropriated. The agency said it would need that much to do the work. The law also authorized $3 million for FY 2000 and FY 2001 for the PMN program. "So far, so good," said Lew Freeman, SPI's vice president of government affairs, noting Republicans and Democrats in Congress have agreed to move the appropriations bills along and not "play politics." Freeman cautioned, however, the appropriation must get through the subcommittees, the full committees and a floor vote on the entire budget before food packaging is in the clear.