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In this Article

• What is "Mad Cow Disease" (Bovine Spongiform Encephalopathy/BSE)?
• What causes BSE?
• Was a second case of BSE identified in the U.S. in June 2005?
• Did meat and meat products from the June 2005 cow enter the food supply?
• Was a case of BSE identified in the U.S. in December 2003?
• Did meat and meat products from the 2003 BSE cow enter the food supply?
• Will there be additional cases?
• Does BSE affect people?
• What measures are being taken to ensure food safety in the U.S. from BSE?
• Are the protective measures in place sufficient to ensure the safety of the human food supply in light of the June 2005 BSE positive cow?
• Is the food in the U.S. likely to be a BSE risk to consumers?
• Is cow's milk a source of BSE?
• Can milk be infected with BSE from a BSE-positive cow?
• Does the use of bovine-derived ingredients in dietary supplements mean that they are not safe?
• Since the BSE-positive cows were discovered in the U.S., does that mean that dietary supplements made with domestic ingredients might be unsafe?
• What steps is FDA currently taking to ensure the safety of dietary supplements that contain bovine ingredients?
• 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?
• What about the use of gelatin, another bovine-related material, in cosmetics and dietary supplements and other foods?
• When and how did BSE in cattle occur?
• Is BSE in cattle the same disease as CWD in deer and elk in the U.S.?
• What countries have reported cases of BSE or are considered to have a substantial risk associated with BSE?
• Mad Cow Disease Glossary
• Mad Cow Disease Index

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.