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FDA News

September 12, 2003

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FDA Warns Milk Producers to Remove "Hormone Free" Claims From the Labeling Of Dairy Products

The Food and Drug Administration (FDA) today issued Warning Letters to four manufacturers of whole milk, reduced fat milk and ice cream, informing them that their products are misbranded because the labels contain the false statements, "No Hormones" or "Hormone Free."

"FDA is committed to assuring that consumers are provided with truthful information on product labels," said FDA Commissioner Mark McClellan, MD., Ph.D.. "FDA will continue to take strong action to protect American consumers from products with labeling that is false or misleading."

During recent inspections, FDA investigators collected labels of dairy products, including various milk and ice cream products. FDA reviewed the labels and determined that the statements "No Hormones" and "Hormone Free" are false claims, and therefore, the products are misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 403(a) of the Act, a product is misbranded if any information presented on the label or labeling is false or misleading.

The Warning Letters explain that "No Hormones" and "Hormone Free" are false claims because all milk contains naturally occurring hormones, and milk can not be processed in a manner that renders it free of hormones.

FDA also cautioned the firms that the agency could pursue further action such as seizure and/or injunction, if they fail to take prompt action to correct their labels.

FDA has stated that food manufacturers who do not use milk from cows treated with recombinant bovine somatotropin (rbST) may voluntarily inform consumers of this fact on their product labels or labeling, provided that the statements are truthful and not misleading.

Before the 1993 approval of rbST, FDA determined that the recombinant, or genetically engineered form of bST is virtually identical to a cow's natural somatotropin, a hormone produced in the pituitary gland that stimulates the production of milk. During that rbST approval process, FDA concluded that there is no significant difference between milk from treated and untreated cows. For that reason, FDA also concluded it does not have the authority to require special labeling for milk and dairy products from rbST-treated cows, and that producers have no basis for claiming that milk from cows not treated with rbST is safer than milk from rbST-treated cows.


This is a mirror of the page at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00943.html

Warning Letters

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