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.

Cigarette and smokeless tobacco and the reasoning behind FDA's proposed regulation of them are the subject of a report published by FDA last Aug. 11. "Nicotine in Cigarettes And Smokeless Tobacco Products Is A Drug And These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act" explains agency findings that nicotine in cigarettes and smokeless tobacco is a drug, and that these products are drug delivery devices and, therefore, fall under FDA jurisdiction. Single copies are available for $21 from Superintendent of Documents, Government Printing Office, Washington, DC 20402; telephone (202) 512-1800. Request stock number 017-012-00373-7. The document is also available on FDA's Internet site at http://www.fda.gov/opacom/campaigns/tobacco.html. (FR Aug. 11)

Condoms and condom-like products, including those marketed as novelty items, are subject to all medical device regulatory requirements, according to a new FDA policy statement. The statement supersedes the agency's 1989 policy on condom labeling. For a free copy of the statement, send two self-addressed labels to Division of Small Business Manufacturers Assistance (HFZ-220), Rockville, MD 20857. Request Docket No. 95D-0162. (FR Aug. 3)

Revised guidance for certain frozen and canned fish, with decomposition and histamine information, is available from FDA. "Decomposition and Histamine--Raw, Frozen Tuna and Mahi-Mahi; Canned Tuna; and Related Species" provides lower histamine action levels. For a free copy, send two self-addressed labels to Office of Constituent Operations, Industry Activities Staff (HFS-565), Washington, DC 20204. Request Docket No. 95D-0157. (FR Aug. 3)

Safety and effectiveness information for 27 class III (high-risk) medical devices must soon be submitted to FDA. The agency is requesting the information to determine whether to revise its classification of the devices or issue new regulations requiring premarket approval. The 27 devices include such products as lung water monitors and implanted neuromuscular stimulators. (FR Aug. 14)

Computer submission of pharmacology and toxicology studies for new drugs is now an option for drug sponsors under a Center for Drug Evaluation and Research pilot program. Sponsors who want more information should contact Patricia A. Sylvia, CDER (HFD-72), Rockville, MD 20857; telephone (301) 443-3695. (FR Aug. 30)

Pesticide residue monitoring data for fiscal year 1994 is available from FDA on computer diskette. This is the third annual comprehensive compilation of monitoring data for pesticide residues in foods that FDA has offered. To order copies of the diskettes (at $50 each), request order number PB95-503132 from the National Technical Information Service, Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161; telephone (703) 487-4650. In addition, shipping and handling costs are $4 for one copy, $6 for two, and $8 for three or more copies. (FR Aug. 24)

Lead information is available in a new pamphlet, "Protect Your Family from Lead in Your Home," developed by the Environmental Protection Agency and Consumer Product Safety Commission. For one free copy, call the National Lead Information Clearinghouse at (1-800) 424-LEAD (TDD 1-800-526-5456). The document is also available through the Internet at gopher://gopher.epa.gov:70/11/Offices/PestPreventToxic/Toxic/lead_pm. Multiple copies are available for $26 per pack of 50 copies from the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954; telephone (202) 512-1800. Request the pamphlet by title and stock number 055-000-00507-9. (FR Aug. 1)

FDA Consumer magazine (November 1995)