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FDA News

FOR IMMEDIATE RELEASE
P04-29
March 9, 2004

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FDA Commends Senate Passage of Bill Providing Improved Consumer Protection and Incentives for Animal Drug Development

FDA commends the Senate's passage of S741, a bill that includes the proposed Allergen Labeling and Consumer Protection Act of 2003, as well as the Minor Use and Minor Species Animal Health Act of 2003. Health, Education, Labor and Pensions Committee Chairman Judd Gregg and Ranking Member Senator Edward Kennedy were instrumental in moving this bipartisan legislation forward.

The Food Allergen Labeling and Consumer Protection Act would 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.

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.

“We hope that these new provisions will be as successful as the FDA's Orphan Drug Program that has enabled many new drugs to be approved for people with rare diseases and conditions, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “FDA is heartened by Senate passage of both of these important measures and looks forward to providing further technical assistance to the House regarding this legislation.”

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