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.
FDA continues to monitor dietary supplements and their ingredients when they enter the country. Those containing bovine-derived ingredients from cattle originating in prohibited countries are prohibited entry into the US. In addition, the restrictions on the use of certain cattle and cattle tissues in human food that were recently announced by USDA will also reduce the risks that potentially infective tissue is used in dietary supplements. FDA is exploring what further safeguards may be needed to provide greater assurance to consumers that dietary supplements and other foods remain safe. 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.
16FDA continues to monitor dietary supplements and their ingredients when they enter the country. Those containing bovine-derived ingredients from cattle originating in prohibited countries are prohibited entry into the US. In addition, the restrictions on the use of certain cattle and cattle tissues in human food that were recently announced by USDA will also reduce the risks that potentially infective tissue is used in dietary supplements. FDA is exploring what further safeguards may be needed to provide greater assurance to consumers that dietary supplements and other foods remain safe. 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.
