FDA News Digest for June 7, 2004

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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
______________________________________________________________

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