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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.
Natural rubber-containing medical devices that may contact human tissue must be labeled as latex and identified as a possible cause of allergic reactions, according to a proposed FDA rule. Hypoallergenicity claims also must be removed from such devices because the current test that supports these claims addresses only chemical sensitivity, not protein sensitivity. FDA is proposing the rule following several reports of severe allergic reactions to a wide range of latex-containing medical devices. Comments on the proposed rule should be sent by Sept. 23 to the Dockets Management Branch (HFA-305), FDA, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. (FR June 24)
Helping patients stop smoking is the topic of new guidelines for health professionals mailed this past summer to the offices of 200,000 primary-care physicians by the U.S. Agency for Health Care Policy and Research (AHCPR). The guidelines also are available in a consumer version. For a free copy, call AHCPR at (1-800) 358-9295.
A new home page for FDA's Center for Drug Evaluation and Research is now on the agency's World Wide Web site at http://www.fda.gov/cder/. The home page offers information about drug approvals, recalls and shortages, as well as the drug center's programs and policies.
Propylene glycol (PG), added to cat food, was excluded from "generally recognized as safe" (GRAS) status in a final FDA rule effective June 3. Manufacturers say PG helps prevent oxidation of components that could affect nutritional properties of the food. But after reviewing currently available information, FDA said "significant questions" remain about PG's safety in cat food. (FR May 2)
Most of the artificial sweetener aspartame' s 23 listed uses were replaced with a single-use category for food in a final FDA rule that became effective June 28. FDA amended food additive regulations to allow safe use of aspartame as a general-purpose sweetener. (FR June 28)
Medical device products that may deplete the Earth's ozone layer, including those containing or manufactured with chlorofluorocarbons (CFCs), must carry warning statements, according to an FDA interim rule that became effective May 17. CFCs are allowed for some "essential" medical device uses, such as in certain metered-dose inhalation devices used to treat asthma. (FR May 3)
FDA Consumer magazine (September 1996)