FDA Considers Banning Human Tissue Imports
Adding to Thursday's recommendation that the FDA ban blood donations from mad-cow afflicted countries, a panel of scientific advisers on Friday recommended that the agency consider banning human tissue imports, the Wall Street Journal reports. The panel said that transplanted tissues "might pose dangers," with transplants of cornea and dura mater -- the membrane that encases the brain -- posing the "greatest risks." In addition, bone-marrow transplants, skin grafts and donated sperm and embryos posed "lesser, but unknown risks." The panel did not recommend specific steps the agency should take in imposing a human tissue ban.
The FDA panel expressed the "greatest concern" over risks associated with dietary and nutritional supplements sold in the United States that are manufactured with imported cow-derived ingredients. "Commo[n]" ingredients found in supplements include bull testicles, thymus, adrenal glands and brains (Regalado, Wall Street Journal, 1/22). Paul Brown, chair of the FDA advisory committee that made recommendations on blood donation, said that brain and pituitary tissue are a "favorite substance in many dietary supplements. God knows what they do in terms of improving human health, but I think there is a real consideration that they might do the reverse." Peter Lurie, a member of the panel, added, "This is a tremendously worrying area. At the present, there may be no evidence of harm," but without accurate labeling a "real hole in the regulations" exists. While importation of tissues and organs of "ruminants, including cattle," from countries reporting mad cow disease has been prohibited by the USDA since 1991, these regulations "do not specifically apply to cosmetics or products used in dietary supplements," USA Today reports. In addition, companies are not required to list products used in dietary supplements on product labels. Linda Detwiler of the USDA said there are "'loopholes' in the system designed to keep bovine extracts" from countries reporting mad cow cases out of the United States. She added, "If it's brought to our attention, we do have the regulatory authority to keep it out. But we have to know about it" (Manning, USA Today, 1/22).
FDA Advisers on Friday did not recommend any action on mad deer disease after hearing evidence from state wildlife officials and elk-breeding industry representatives. They also "rejected" the notion of banning blood donations from hunters or other individuals "potentially exposed to sick animals" (Wall Street Journal, 1/22). On NPR's "Morning Edition" today, Commentator David Ropeik called the FDA's efforts to protect Americans from mad cow "largely successful," but noted that a "fear of the disease persists." To listen to the NPR report, go to http://search.npr.org/cf/cmn/cmnpd01fm.cfm?PrgDate=01/22/2001&PrgD=3I. Note: You must have RealAudio to listen to the report.
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