Notebook

The Notebook: a potpourri of items of interest gathered from FDA news releases, other news sources, and the Federal Register (designated FR, with date of publication). The Federal Register is available in many public libraries. It is also available electronically through GPO Access at the Government Printing Office.

The infant formula regulations comment period has been extended to Dec. 6 by FDA. Revisions the agency is proposing include:

setting standards for current good manufacturing practice
amending requirements on quality control procedures, notification, records, and reports
requiring infant formulas to contain, and be tested for, certain nutrients.

Written comments should be submitted to the Dockets Management Branch (HFA-305), FDA, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857. (FR Sept. 23)

Folic-acid-fortified grain products marketed before Jan. 1, 1998--when fortification becomes mandatory--do not have to be labeled as containing folic acid unless a health claim for the nutrient is made, according to an FDA final rule. FDA originally had required fortification before Jan. 1, 1998, to be indicated on labeling. But the agency reconsidered after receiving a letter from the March of Dimes pointing out that though manufacturers want to fortify earlier than the deadline, many are holding off because they could not use existing label stocks. FDA mandated folic acid fortification because of evidence that the nutrient can reduce the risk of neural tube birth defects such as spina bifida. (FR Sept. 5)

Blood collection and distribution facilities must quarantine whole blood and blood products taken from a donor who initially tests negative for HIV antibodies but later tests positive, according to a final FDA rule. Facilities also must prepare and follow written standard operating procedures that define steps to be taken when screening tests show later batches of a donor's blood to be reactive to HIV antibodies. Facilities then must perform a licensed, more specific HIV antibody test. (FR Sept. 9)

Administering streptokinase to stroke victims more than three hours after the stroke is not helpful and may cause more serious problems, according to Australian research. Streptokinase is a blood-clot-dissolving drug. The study of 340 patients sought to determine if giving the drug within four hours of the onset of acute ischemic stroke (insufficient blood supply to the brain) would reduce disability or death. The trial was stopped early because of unacceptably high complication rates. The researchers say larger trials are needed to test further the effectiveness of therapy given within three hours. They add that public education may be needed to increase the number of patients who seek treatment early after a stroke. (Journal of the American Medical Association, Sept. 24)

High school students who drink alcohol or use illegal drugs, including anabolic steroids, are more than twice as likely as teenagers who don't use drugs to carry a weapon or get into a fight. A survey of more than 12,000 high school students in the United States shows the increased risk of violence is similar among adolescents regardless of gender. (Archives of Pediatrics and Adolescent Medicine, 1996)

FDA Consumer magazine (December1996)