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BID TO REFORM FDA NEARS COMPLETION WITH HOUSE OK

WASHINGTON (FNS) -- Congress drew closer to completing a three-year effort to reform the Food and Drug Administration with the recent House vote to approve its version of reform of the agency that regulates food safety, drugs and medical devices.The House approved its version of FDA reform in a voice vote, while the Senate approved its version in an overwhelming 98-2 vote Sept. 24. The two bills are

WASHINGTON (FNS) -- Congress drew closer to completing a three-year effort to reform the Food and Drug Administration with the recent House vote to approve its version of reform of the agency that regulates food safety, drugs and medical devices.

The House approved its version of FDA reform in a voice vote, while the Senate approved its version in an overwhelming 98-2 vote Sept. 24. The two bills are expected to be reconciled in the coming weeks.

The landmark legislation addresses change to labels as they relate to important concerns such as food safety and nutritional information.

On irradiation, the bill removes the current requirement that the radiation symbol be displayed prominently when food is irradiated to remove bacteria, parasites, mold and fungi. Some think the symbol is having the unintended effect of scaring consumers away from a product that the government has determined to be safe.

The legislation would also permit health claim information on food labels, provided a scientific body of the federal government has published a statement providing a scientific basis for the health claim; and the food does not contain a disqualifying level of fat, saturated fat, cholesterol or salt. The reform initiative would permit nutrient content information in cases where the FDA has not promulgated regulations, as long as scientific evidence is available. The bill also would eliminate the requirement that nutrient-content claims be accompanied by the referral statement, "see back panel for nutrition information," on the grounds that most consumers are familiar enough with package design to know where to look.

In addition, the bill would permit food manufacturers to market new products if the FDA does not within 120 days object to the type of packaging and surfaces that come in contact with the food.

Current law requires the FDA to put surfaces that come into contact with food through a sometimes lengthy process of approval.

The measure removes several regulations covering the sale of margarine and puts the product under the same rules that govern vegetable and butter products. Currently, margarine must meet more rigid standards for fear that customers don't know the differences between it and butter.

The Grocery Manufacturers of America here has lauded House passage of the measure, calling it "an important first step in improving the food functions of the FDA."

It would also expedite FDA approval of new medicines, streamline the approval process for medical devices, ease access to experimental drugs and reauthorize the Prescription Drug User Fee Act.