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November 24, 2009
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Mad Cow Disease (cont.)

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Since the BSE-positive cows were discovered in the U.S., does that mean that dietary supplements made with domestic ingredients might be unsafe?

No. The requirements that FDA has in place should give consumers confidence that their food, including dietary supplements, is safe. Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. Furthermore, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive.

Even though BSE-positive cows have been identified in the U.S., one of which was imported, the risk to human health from dietary supplements and other foods containing cattle-derived ingredients is extremely low.

What steps is FDA currently taking to ensure the safety of dietary supplements that contain bovine ingredients?

Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. The rule applies to both domestic and imported dietary supplements and their ingredients. In addition, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive. Further, the restrictions by USDA on the use of certain cattle and cattle tissues in human food also reduce the risks that potentially infective tissue would be used in dietary supplements. FDA also has proposed a requirement that manufacturers and processors that use cattle material in their products would be required to keep records demonstrating that these materials do not contain prohibited cattle material and that these records be made available to FDA for inspection.

Given the BSE case in Washington State and the case in Texas, should consumers be concerned about cosmetics made using tallow from the rendering process?

No. The World Health Organization considers tallow to be a low risk for transmission of BSE. Specifically, the rendering process separates fats from proteins. Because the disease is transmitted by prions, which are a type of protein, they would be separated by the rendering process from the tallow or fat, which is the portion that goes into cosmetics. Additionally, the tallow is processed with excessive heat and pressure which may further minimize any risk of infectivity prior to use in cosmetics.



Next: What about the use of gelatin, another bovine-related material, in cosmetics and dietary supplements and other foods? »

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