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.

Food label placement will be permitted greater flexibility on packaged foods, according to an FDA final rule effective last May 5. The rule allows the label to be placed on any panel that can be readily seen by the consumer in situations where the principal display and information panels cannot accommodate all required labeling information, and the package has a total surface area of more than 40 square inches. (FR April 5)

Names of patients and those reporting to FDA adverse events associated with regulated products will not be disclosed by the agency, according to a final rule effective July 3, 1995. The rule helps maintain FDA's ability to collect information about safety risks of human drugs, biologicals, and medical devices. The rule also preempts state or local laws requiring disclosure of an individual's name. (FR April 3)

Jaguar brand bicycle helmets, model 3060, are being recalled by Protective Technologies International, Inc. (PTI), because the helmet liners failed head impact tests and may not prevent injuries. In cooperation with the Consumer Product Safety Commission, PTI, the manufacturer, is recalling 25,000 helmets sold nationwide at Toys 'R' Us and Target stores from September 1994 to January 1995. Consumers should call PTI at (1-800) 515-0074 to receive a United Parcel Service tag to return the helmet. PTI will send consumers a new helmet that meets safety standards.

A cumulative orphan products list is available from FDA. The list, updated monthly, identifies the drugs and biologics granted orphan status under the Food, Drug, and Cosmetic Act. Free copies are available from FDA, Office of Orphan Products (HF-35), Rockville, MD 20857; telephone (301) 443-4718. (FR April 19)

Manufacturers of licensed biological products can find out about reporting changes in a Federal Register document, "Changes to be Reported for Product and Establishment License Applications; Guidance." The document provides manufacturers of licensed biological products guidance on manufacturing changes that don't need prior approval by FDA's Center for Biologics Evaluation and Research director and on changes that do need approval. (FR April 6)

Over-the-counter products to treat pancreatic enzyme deficiency are not generally recognized as safe and are misbranded, according to an FDA final rule that takes effect Oct. 24, 1995. After that date, no such OTC products may be initially introduced or delivered for introduction into interstate commerce unless they have been approved by FDA. (FR April 24)

Testicular prostheses can no longer be distributed unless the manufacturer or importer has filed with FDA a premarket approval application or a notice of completion of a product development protocol, according to an agency final rule effective last April 5. The prostheses are generic, surgically implanted medical devices intended to simulate the presence of a testicle within the male scrotum. (FR April 5)

Homelessness and migrancy have been added to the list of predisposing risk conditions to qualify a person for the Special Supplemental Nutrition Program for Women, Infants and Children, according to a final rule from the U.S. Department of Agriculture's Food and Consumer Service. The rule was effective last April 19. (FR April 19)

The Social Security Administration became an independent agency in the U.S. government's executive branch, according to a final rule effective last April 14. Social Security, formerly a part of the Department of Health and Human Services, continues to be responsible for administering the old-age, survivors, and disability insurance and the Supplemental Security Income programs. (FR April 14)

FDA Consumer magazine (July-August 1995)