FDA News Digest June 7, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- Illnesses Associated With School Lunches in Massachusetts Investigated -- FDA Revises Guidance on Reprocessing Single-Use Devices -- Booklet Aims to Help Consumers Make Informed Medicine Choices -- FDA Finds No Additional Approved Outside Activities of Concern -- Recalls/Market Withdrawals -- Public Meetings ______________________________________________________________ Illnesses Associated With School Lunches in Massachusetts Investigated Following four outbreaks of illness in children related to meals served at several Massachusetts schools, FDA is investigating the incidents to determine the cause. So far, most of the illnesses appear to be linked to a certain type of tortilla. FDA is working on the case with the Massachusetts Department of Public Health and the Centers for Disease Control and Prevention. http://www.fda.gov/bbs/topics/news/2004/NEW01074.html FDA Revises Guidance on Reprocessing Single-Use Devices FDA has issued revised guidance to clarify new procedures and timeframes for the agency's review of the validation data that companies submit for certain reprocessed single-use devices. Validation data includes information on cleaning, sterilization, and functional performance to ensure that the reprocessed device is substantially equivalent to the original single-use device. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01291.html Booklet Aims to Help Consumers Make Informed Medicine Choices FDA has teamed with the Council on Family Health to develop "Be An Active Member of Your Health Care Team," a free publication that urges consumers to take an active role in their health care, especially when using medicines. Included is a question guide to help improve communication between patients and health care providers. Press release (English): http://www.fda.gov/bbs/topics/news/2004/cfh0604.html Press release (Spanish): http://www.fda.gov/bbs/topics/news/2004/cfh0604sp.html FDA Finds No Additional Approved Outside Activities of Concern Following discovery of one incidence of an outside activity of concern, FDA has conducted a comprehensive internal review of all outside activities of FDA employees and has found no other activities of concern. The review covered more than 1,800 outside activity requests by FDA employees for both paid and unpaid work. http://www.fda.gov/bbs/topics/news/2004/NEW01076.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS ONGOING RAW ALMOND RECALL -- As part of an earlier recall of raw almonds by Paramount Farms due to possible Salmonella contamination, several almond distributors and retailers continue to conduct their own recalls. For a complete list of all almond recalls to date, go to http://www.fda.gov/oc/po/firmrecalls/almonds.html. To view information about just the most recent recalls from each outlet, go to the links that follow: -- Certain lots of Mr. Nature Aloha Mix (2 oz.), Energizer Mix (2 oz.), Mix N Yogurt (2 oz.), and Trail Mix (3.5-, 2 -, and 1.1-oz.sizes) http://www.fda.gov/oc/po/firmrecalls/nature05_04.html -- Certain lots of: Superior Nut and Candy Tropical Mix (25-lb. size), Jake's Trading Co. Energy Mix (16 oz.), Imperial Foods Tropical Mix (5 oz.), Figis California Fruit Mix (25-lb. cases), Caito Foods Tropical Mix (16 oz.), Imperial Foods Tropical Mix (5 oz.), and Warner Candies Whole Almonds (2.25 oz.) http://www.fda.gov/oc/po/firmrecalls/superior05_04.html -- Several varieties and sizes of Barcelona Nuts containing raw whole or diced almonds http://www.fda.gov/oc/po/firmrecalls/barcelona06_04.html -- Expanded recall: Metropolitan Market whole raw or diced almonds (8- and 16-oz. sizes) http://www.fda.gov/oc/po/firmrecalls/metro06_04.html -- American Spoon Foods Cherry Berry Nut Mix (6-oz. and 1-lb. sizes) and American Spoon Bar Mix (7 oz.) http://www.fda.gov/oc/po/firmrecalls/americanspoon06_04.html -- Cherry Republic Cherry Nut Mix and Cherry Trail Mix (8-oz. and 1-lb. sizes) http://www.fda.gov/oc/po/firmrecalls/cherryrepublic06_04.html -- DeLaurenti Specialty Food Store raw whole almonds (4-oz., 8-oz., and 1-lb. sizes) http://www.fda.gov/oc/po/firmrecalls/delaurenti05_04.html -- Gold Shield whole raw almonds (2.5- and 8-oz. size) http://www.fda.gov/oc/po/firmrecalls/pacific05_04.html -- Harvest Health Foods Raw Almonds and Harvest Mix http://www.fda.gov/oc/po/firmrecalls/harvest05_04.html -- Jack's Market raw whole or dices almonds (1-lb. sizes) http://www.fda.gov/oc/po/firmrecalls/jacks06_04.html -- Larry's Market bulk raw whole almonds http://www.fda.gov/oc/po/firmrecalls/larry05_04.html -- Nut Bar Company bulk raw almonds (1-lb. size) http://www.fda.gov/oc/po/firmrecalls/nutbar05_04.html -- Oasis Almond Garlic Spread (8 oz. tubs) http://www.fda.gov/oc/po/firmrecalls/kastoria06_04.html -- R. Hirt raw almonds (1- and 5-lb. sizes); Paramount raw almonds (50-lb.) http://www.fda.gov/oc/po/firmrecalls/hirt05_04.html -- Royal Candy & Nut Co. Raw Whole Almonds (1 oz.) and California Mix (2.1 oz.) http://www.fda.gov/oc/po/firmrecalls/royal05_04.html -- St. Laurent Brothers raw whole almonds (50-lb. boxes) http://www.fda.gov/oc/po/firmrecalls/stlaurent05_04.html The following other products are being recalled for the reasons shown. Go to the linked pages for more information. Winiary Mayonnaise (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/lowell06_04.html Sprouters Northwest raw alfalfa sprouts; 2-, 3-, 5-lb. sizes (possible Salmonella contamination) http://www.fda.gov/bbs/topics/news/2004/NEW01075.html For a listing of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ PUBLIC MEETINGS June 10-11 -- "Strategies for Developing Therapeutics That Directly Target Anthrax and Its Toxins" (Bethesda, Md.) http://www.fda.gov/OHRMS/DOCKETS/98fr/04-10460.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be June 14. 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