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July 20, 2004

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FDA Commends Passage by the House of Representatives of S. 741, a Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development

FDA commends the passage by the House of Representatives of S. 741, a bill that includes the Food Allergen Labeling and Consumer Protection Act, as well as the Minor Use and Minor Species Animal Health Act (MUMS). Energy and Commerce Committee Chairman Joe Barton and Ranking Member John D. Dingell were instrumental in moving this bipartisan legislation forward in the House. House approval of the Senate-passed bill represents final Congressional action that clears the way for enactment of this important legislation that will help consumers identify foods that can cause severe allergic reactions and separately that will help create new incentives to develop and seek approval for treatments of diseases in animals, including zoo animals, exotic species and pets. The Agency applauds the dedication and leadership of the bill's sponsors in the Senate, including Health, Education, Labor, and Pensions Committee Chairman Judd Gregg and Ranking Member Edward Kennedy as well as Senators Jeff Sessions and Jeff Bingaman. In the House, the primary sponsors of companion legislation on food allergen labeling legislation were Representatives Nita M. Lowey and James C. Greenwood and, for companion legislation on MUMS, the primary sponsor was Representative Charles W. Pickering.

The Food Allergen Labeling and Consumer Protection Act will provide improved food labeling information to the millions of consumers who suffer from food allergies. It requires food labels to identify in plain English if the product contains any of the eight major food allergens - milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, wheat and soybeans.

This labeling will be especially helpful to children who must learn to recognize the presence of substances they must avoid. For example, if a product contains the milk-derived protein casein, the product's label would have to use the term "milk" in addition to the term "casein" so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

FDA's Acting Commissioner Dr. Lester M. Crawford said today, "FDA applauds the passage of the Food Allergen Labeling and Consumer Protection Act. It will be of great help to consumers that are prone to allergies. We welcome this legislation which is consistent with FDA's initiatives to provide consumers with the information they need to make healthy choices."

The Minor Use and Minor Species Animal Health Act is intended to increase the availability of new therapies for animals, including zoo animals and some pets for which treatments for many ailments currently do not exist or are not available. This legislation will establish two new ways to lawfully market new animal drugs while safeguarding public health and make available incentives, such as grants, for certain new animal drugs for minor uses and minor species.

"Increasing the availability of safe and effective drugs to treat minor species and other species with unusual conditions promotes animal welfare and provides additional public health protection from animal diseases that can be transferred to humans, said Dr. Crawford "FDA is pleased by House and Senate passage of both of these important measures."


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