FDA News Digest for March 12, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

March 12, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- New Type of Drug Approved to Treat High Blood Pressure

    -- Guidelines Proposed for Safe Processing of Fresh-Cut Produce

    -- Latest 'Patient Safety News' Video Program Available Online

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

New Type of Drug Approved to Treat High Blood Pressure

FDA has approved Tekturna (aliskiren) tablets, a new type of drug for treating high blood pressure, or hypertension. The drug works by inhibiting renin, a kidney enzyme associated with blood pressure regulation. Affecting about one quarter of Americans, high blood pressure is sometimes called the "silent killer" because it often has no symptoms but can increase the risk of stroke, heart attack, kidney failure, heart failure, and death.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01580.html

-- More on high blood pressure: www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html

 

Guidelines Proposed for Safe Processing of Fresh-Cut Produce

FDA is proposing guidelines that advise processors of fresh-cut produce how to minimize food safety hazards common to production of fresh fruits and vegetables sold in a ready-to-eat form (such as shredded lettuce, peeled baby carrots, and cut celery stalks). Processing produce into fresh-cut product increases the risk of contamination because it breaks the produce's natural barrier. The new FDA guidelines aim to help the fresh-cut industry prevent or eliminate potential hazards, or reduce them to acceptable levels. 

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01584.html

-- Fact sheet: http://www.fda.gov/oc/factsheets/foodsafety2007.html

Note: FDA Consumer magazine has published a related feature article called "How the FDA Works to Keep Produce Safe." To read it, go to http://www.fda.gov/fdac/features/2007/207_foodsafety.html.

 

Latest 'Patient Safety News' Video Program Available Online

FDA has posted the latest edition of "Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

http://www.fda.gov/psn

Note: "Patient Safety News" also is available as a Podcast at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm.

 

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 Recalls:

 

All Peter Pan peanut butter, and Great Value peanut butter beginning with product code 2111, including peanut butter toppings, dating from October 2004

    Reason for recall: possible Salmonella contamination

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01583.html

-- Questions and answers: http://www.cfsan.fda.gov/~dms/pnutbuqa.html

Note: FDA continues to advise consumers not to eat Peter Pan peanut butter, or Great Value peanut butter with product code 2111

 

Jermuk brand mineral water (imported from Armenia), bottled under different labels

    Reason for recall: high levels of arsenic found in the product

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01581.html

Note: Due to the toxicity of arsenic, FDA is warning consumers not to drink this brand of water

 

Various types of Dal Raccolto olives (sold primarily to restaurants and other food service institutions)

    Reason for recall: potential botulism risk

http://www.fda.gov/oc/po/firmrecalls/cibo03_07.html

 

One lot of Cerignola olives, 25 oz. size (distributed in Florida, Georgia, and upstate New York)

    Reason for recall: potential botulism risk

http://www.fda.gov/oc/po/firmrecalls/flora03_07.html

 

Safety Alerts:

 

FDA and the makers of anemia treatments known as Erythropoiesis-Stimulating Agents (ESAs) have agreed on revised labeling for the products. The revisions include a boxed warning that advises doctors to monitor red blood cell levels (hemoglobin) in patients and to adjust ESA doses to maintain the lowest hemoglobin levels needed to avoid blood transfusions.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.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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CONGRESSIONAL TESTIMONY

 

March 12-- FDA Commissioner Andrew C. von Eschenbach, M.D., testified before the Senate Agriculture, Rural Development, and Related Agencies Appropriations Subcommittee.

     Subject: safety of fresh produce

http://www.fda.gov/ola/2007/foodsafety31207.html

 

March 7 -- FDA Acting Deputy Commissioner for Policy Randall W. Lutter, Ph.D., testified before the Senate Interstate Commerce, Trade, and Tourism Subcommittee

    Subject: policy implications of importing drugs into the United States

http://www.fda.gov/ola/2007/importdrugs30707.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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UPCOMING PUBLIC MEETINGS

 

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

 

March 29 -- Food Defense Workshop

    Under discussion: regulations authorized by the Bioterrorism Act of 2002 and other subjects related to FDA-regulated food facilities

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-19886.htm

 

April 10-11 -- Food Labeling Workshop (jointly sponsored by FDA and the University of Arkansas

    Under discussion: FDA food labeling regulations, especially as they relate to small businesses and startups

    Location: Fayetteville, Ark.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1570.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

 

How can I participate in FDA's process for making its rules? 

In general, any citizen can submit comments on rules FDA proposes. The agency announces rules in the Federal Register and usually accepts comments for 60 days. The Federal Register is available in many libraries or by going to the link below. FDA urges consumers to participate in the rulemaking process. For more information about submitting comments, call the FDA Dockets Management Branch at (301) 827-6860.

-- FDA Federal Register page: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm

-- More on submitting comments to FDA: http://www.fda.gov/opacom/backgrounders/voice.html

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