January 17, 2007

FDA proposes ban on high-risk cattle material from drugs

The US Food and Drug Administration (FDA) announced to prohibit certain cattle material from drugs, biologics and medical devices to lower the risk of BSE or mad cow disease.

Under the proposed regulation, the banned products could not be used as ingredients in medical products or as a part of their manufacturing processes, the FDA said.

Cattle materials deemed to have the highest concentrations of the BSE agent and which have been called for a ban include brains, skulls, eyes and spinal cords from cattle 30 months and older; tonsils and a portion of the small intestines from all cattle; any material from cattle that cannot walk; any material from cattle not inspected and approved for human consumption; fatal calf serum if procedures have not been followed to prevent its contamination with other banned materials;  tallow containing more than 0.15 percent insoluble impurities if derived from banned materials; and mechanically separated beef.

The rule would cover prescription, OTC and homeopathic drugs, as well as biologics, medical devices and drugs for use in ruminant animals like cattle and sheep, the agency said.

Noting the possible link between outbreaks of BSE and the human disease variant Creutzfeldt-Jakob disease (vCJD), the FDA said when humans ingest contaminated cattle products containing the BSE agent, it could lead to vCJD.