FDA News Digest for March 5, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

March 5, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- First Test OK'd to Screen for West Nile in Blood, Tissue Donors

    -- FDA Tells 20 Firms to Stop Marketing Illegal Migraine Drugs

    -- Guidelines Tell How Drug Safety Information is Made Public

    -- FDA Food Processing/Packaging Official Receives Top Honor

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

First Test OK'd to Screen for West Nile in Blood, Tissue Donors

FDA has approved the first fully automated West Nile virus test for donor screening. The test is intended for blood, tissue and organ donors only and not for use on cord blood specimens or as an aid in West Nile virus diagnosis. FDA says the fully automated feature "can reduce the potential for human error."

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01578.html

 

FDA Tells 20 Firms to Stop Marketing Illegal Migraine Drugs

FDA has told 20 companies to stop marketing unapproved drug products containing ergotamine tartrate. The products are used to treat vascular headaches, including migraines. The agency is concerned that the drugs have not undergone FDA review; thus the safety, effectiveness and quality of the products are unknown. The crackdown is part of the Unapproved Drugs Initiative, an agency effort to get unapproved drugs off the market.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01575.html

 

Guidelines Tell How Drug Safety Information is Made Public

FDA has issued final guidelines describing how the agency communicates drug safety information, including emerging safety alerts, to the public. FDA's goal is to give patients and health care providers information to help them make well-informed treatment choices.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01577.html

 

FDA Food Processing/Packaging Official Receives Top Honor

John Larkin, Ph.D., who oversees process engineering for FDA's Food Processing and Packaging Division, has received the 2007 Marvin A. Tung Achievement Award from the Institute for Thermal Processing Specialists (IFTPS). The highest honor given by IFTPS, the Tung Award recognizes "academic, regulatory, or industrial achievement in the areas of preservation and packaging of foods."

http://www.iftps.org/tung.html

 

To view an archive of past FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.   

 

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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RECALLS/SAFETY ALERTS

Food Recall:

 

Simply Fresh Fruit Fresh Cut Fruit trays (with "sell by" date of 2/26/07)

    Reason for recall: cantaloupe may be contaminated with Salmonella

http://www.fda.gov/oc/po/firmrecalls/simplyfresh03_07.html

 

Medical Device Recall:

 

Certain lots of Salivart Oral Moisturizer (used to moisten the mouth and throat)

    Reason for recall: may fail to meet specifications for aerobic microorganisms and mold

http://www.fda.gov/oc/po/firmrecalls/gebauer03_07.html

 

Safety Alerts:

 

FDA is investigating an outbreak of norovirus-associated illness linked to eating raw oysters harvested from San Antonio Bay, Texas. As a result, the agency is advising consumers not to eat raw oysters harvested after Feb. 1 from this area of Texas.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01579.html

 

FDA is warning consumers of the dangers of drinking raw milk, or milk that has not been pasteurized. Raw milk potentially contains a variety of harmful bacteria including Salmonella, Listeria, and E. coli O157:H7. Government figures show that between 1998 and 2005, unpasteurized milk was responsible for 1,007 illnesses, 104 hospitalizations, and two deaths.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01576.html

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

 

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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UPCOMING PUBLIC MEETINGS

 

March 7-8 -- Public meeting to discuss formation of a "sentinel network," which would link public and private sector postmarket medical product safety efforts

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-141.htm

 

March 29 -- Anesthetic and Life Support Drugs Advisory Committee

    Under discussion: findings of nervous system degeneration in juvenile animals exposed to anesthetic drugs and relevance to pediatric patients

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1991.htm

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

Why is it important to use a cooking thermometer?

One of the critical factors in fighting foodborne illness is temperature. Bacteria grow slowly at low temperatures and multiply rapidly at mid-range temperatures. And to be safe, a product must be cooked to an internal temperature high enough to destroy harmful bacteria.

 

Using a meat thermometer is a reliable way to ensure that food has reached the proper temperature. However, to be effective, thermometers must be used properly and calibrated correctly. If the thermometer is inserted incorrectly, or placed in the wrong area, the reading may not accurately reflect the internal temperature of the product. In general, the thermometer should be placed in the thickest part of the food, away from bone, fat or gristle. Read the manufacturer's instructions on how to check the accuracy of the thermometer.

 

According to the U.S. Department of Agriculture, measuring temperature is the only way to gauge whether food is sufficiently cooked. USDA research reveals that the "color test" is a misleading way to gauge the safety of foods being prepared, since the color of cooked foods varies considerably. For example, freezing and thawing may influence a meat's tendency to brown prematurely.

 

For more on food safety, see http://www.foodsafety.gov/. 

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Correction:  A spelling gremlin snuck into FDA News Digest

last week. Our item about the asthma drug Xolair incorrectly

spelled the product name "Zolair."

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