To: Manufacturers and Importers of Dietary Supplements and Dietary Supplement Ingredients:
The Food and Drug Administration (FDA) is taking this opportunity to reiterate certain public health and safety concerns to firms manufacturing or importing dietary supplements that contain specific bovine tissues. The safety concerns about bovine-derived dietary supplement ingredients, including extracts or substances derived from such tissues, are a result of the fact that bovine-derived ingredients from cattle born, raised, or slaughtered in certain countries present a risk of transmitting the infectious agent that causes bovine spongiform encephalopathy (BSE) to humans consuming such products. FDA strongly recommends that firms should consider the public health consequences of this disease in taking whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists.
Background
BSE is a transmissible neurologic disorder of cattle and is prevalent in certain parts of the world. This neurological disease is one of a number of transmissible spongiform encephalopathies (TSE) known and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in humans. It is believed that the spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). BSE has never been diagnosed in cattle in the United States. However, although steps have been taken to control the spread of BSE in cattle, new cases of BSE continue to be identified in certain European countries. This fact illustrates that serious public health risks associated with the consumption of animal-derived ingredients from animals sourced from BSE-positive countries remain because such tissues may contain the causative agent of BSE.
Recommendations
Although there is still no definitive evidence that the consumption of bovine tissues that contain the transmissible agent for BSE cause CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted by firms that use bovine-derived ingredients in their products. The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. Currently, the list of countries in which BSE is know to exist includes Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland, Switzerland, Oman, and Belgium.
We strongly recommend that firms manufacturing or importing dietary supplements which contain specific bovine tissues (see enclosure), including extracts or substances derived from such tissues, take all steps necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists. FDA believes that any firm using BSE-derived ingredients should take immediate and continued actions to minimize the potential risk of human exposure to the infectious agent that causes BSE in cattle.
We appreciate your attention to and cooperation in this matter. If you need more information or have questions, please contact the Director, Division of Compliance and Enforcement (HFS-810), Office of Nutritional Products, Labeling, and Dietary Supplements, 200 C St., SW, Washington, DC 20204 (telephone 202-205-5229) or your local FDA District Office.
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Sincerely,
Christine J. Lewis, Ph.D. |
List of Tissues with Suspected Infectivity(1)
Category I (High infectivity)
Category II (Medium infectivity)
Category III (Low infectivity)
List taken from Report of a WHO Consultation on Public Health Issues Related to Animal and Human Spongiform Encephalopathies, World Health Organization, Office of Interantional Epizootics, Geneva, Switzerland, November 12-14, 1991.
Hypertext updated by bap/dms 2000-NOV-22