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FDA reform bill passed

Congress eked out an agreement on the FDA reform bill and passed the legislation on November 9 as members were scrambling to get out of town for the year.
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Compromises were reached on numerous issues including the amendment allowing packaging manufacturers to file premarket notification (PMN) with the FDA for a new product instead of having to go through the long drawn-out approvals process (see p. 36). The substance of the amendment remains as it was. Companies may start filing PMNs on April 1 1999. However a precondition is congressional approval of $1.5 million to administer the new program in fiscal 1999. That fiscal year begins October 1 1998. For fiscal years 2000 and beyond Congress would have to approve $3 million a year. The packaging industry was willing to pay fees to fund the new program. So the fact that the federal government will pay the freight is a positive development. The final bill also allows a food company to give the FDA 120 days' notice on a new health or nutritional content claim it is putting on a product label. That claim has to be backed up by authoritative statements from a federal scientific body such as the National Institutes of Health or National Academy of Sciences.

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