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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.

Cocoa butter substitutes made from safflower or sunflower oil, proposed for use in frostings, candy coatings, and sweet toppings, are generally recognized as safe, according to a final FDA rule. The agency based its ruling in part on a comparison of the new substitutes with an existing cocoa butter substitute made from palm oil. (FR July 10)

The effective date for certain portions of the regulation requiring medical device manufacturers to report adverse events has been temporarily delayed. The delay will allow FDA to evaluate new issues on the 1995 rule concerning industry burdens and to determine if requirements should be revised. (FR July 31)

The first recognized case of group O HIV infection has been reported in the United States, according to the national Centers for Disease Control and Prevention. CDC described the case as a woman who recently came from West Central Africa, where group O HIV is found almost exclusively, accounting for about 6 percent of AIDS cases there. Despite clinical findings consistent with HIV infection, the patient's blood tested negative or inconclusive for HIV over a two-year period. FDA has asked manufacturers of HIV screening tests to develop modified tests that could reliably detect the new strain. Several tests sensitive to group O are in development. For more information about group O HIV, call CDC's National AIDS Hotline, (1-800) 342-2437. (Morbidity and Mortality Weekly Report, July 5)

Reducing pathogenic microorganisms such as Salmonella in poultry and meat products is the subject of new requirements established in a final rule by the Food Safety and Inspection Service of the Agriculture Department. Under the rule, food establishments must use written sanitation standard operating procedures, slaughterhouses must conduct regular microbial testing and establish reduction standards for Salmonella, and all meat and poultry establishments must implement a system of preventive controls to improve product safety. (FR July 25)

Child-resistant packaging has saved hundreds of lives since it was mandated for oral prescription drugs in 1974, according to an article in the Journal of the American Medical Association. Researcher Gregory Rodgers, Ph.D., found that an average of 24 fewer children's deaths from accidental overdose occurred annually from 1974 through 1992. (JAMA, June 4)

Bed-wetting, or primary nocturnal enuresis, can continue until age 18, and studies have indicated it can cause low self-esteem, attention deficit, or behavioral problems. Parents of bed-wetting children now can call a National Kidney Foundation hot line at (1-800) 622-9010 to receive free information and a referral to a local physician who treats the condition.

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FDA Consumer magazine (October 1996)