FDA News Digest for August 1, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

August 1, 2005

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IN THIS WEEK'S ISSUE

 

--  FDA Joins Other Groups to Protect U.S. From 'Agroterrorism'

--  Agency Says Mentor's Silicone Breast Implants Are 'Approvable' 

--  FDA Bans Baytril for Use in Treating Poultry Bacterial Infections

--  Consumers Warned About Fake Lipitor Recalled in United Kingdom

--  Fla. Maker of Cold, Cough Products Shut Down for Violations

--  Contaminated Basmati Rice from Pakistan Seized in New Jersey

--  Commissioner Announces Appointments to Senior Agency Positions

--  Galson Named Permanent Head of Drug Evaluation and Research

--  Recalls/Safety Alert

--  Public Meetings

--  Question of the Week

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FDA Joins Other Groups to Protect U.S. From 'Agroterrorism'

 

FDA is collaborating with three other federal agencies, along with states and private industry, in a program to protect the nation's food supply from terrorist threats. As part of the program, teams of federal and state officials will travel to all 50 states over the next year to meet with food industry representatives and discuss ways to prevent "agroterrorism" by boosting food security from farm to table.

http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0279.xml 

 

Agency Says Mentor's Silicone Breast Implants Are 'Approvable' 

 

FDA has issued an "approvable" letter to Mentor Corp. for its application to market silicone gel-filled breast implants. An approvable letter is one of several steps in the FDA review of new products. The letter does not mean that FDA has approved the implants for marketing at this time.

http://www.fda.gov/bbs/topics/news/2005/new01213.html

 

FDA Bans Baytril for Use in Treating Poultry Bacterial Infections

 

FDA will no longer allow distribution or use of the antibiotic Baytril (enrofloxacin) to treat bacterial infections in poultry. FDA took the action after determining that the drug can promote resistance in Campylobacter bacteria, a major cause of foodborne illness. The agency's ruling does not affect other approved uses of the drug.

http://www.fda.gov/bbs/topics/news/2005/new01212.html

 

Consumers Warned About Fake Lipitor Recalled in United Kingdom

 

FDA is alerting consumers that officials in the United Kingdom have recalled a batch of counterfeit Lipitor, a cholesterol-lowering medicine. U.S. patients who bought FDA-approved Lipitor from legitimate sources should not have received these fake versions. It is possible, however, that those who bought drugs from the U.K. online or through storefronts or state-run reimportation programs may have received the counterfeits.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01216.html

 

Fla. Maker of Cold, Cough Products Shut Down for Violations

 

Following a long history of manufacturing violations, a federal district court has shut down operations at Florida-based Pharmakon Labs, makers of cold and cough products. As part of the court's decision, the company cannot resume manufacturing or distribution of the products until it complies with federal laws.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01211.html

 

Contaminated Basmati Rice from Pakistan Seized in New Jersey

 

U.S. marshals have seized $80,000 worth of basmati rice at POF International in Irvington, N.J. Laboratory analysis of the rice revealed it contained weevils, beetles, and insect larvae, rendering it unfit to eat. The rice originated in Pakistan.

http://www.fda.gov/bbs/topics/news/2005/field07_28.html

 

Commissioner Announces Appointments to Senior Agency Positions

 

FDA Commissioner Lester M. Crawford, D.V.M., has announced the following appointments to senior FDA positions: Scott Gottlieb, M.D., deputy commissioner for medical and scientific affairs; Janet Woodcock, M.D., deputy commissioner for operations and chief operating officer; Murray Lumpkin, M.D., deputy commissioner for international and special programs; and Patrick Ronan, chief staff officer to the commissioner.

http://www.fda.gov/bbs/topics/news/2005/new01215.html

 

Galson Named Permanent Head of Drug Evaluation and Research

 

Steven Galson, M.D., has been named director of the FDA Center for Drug Evaluation and Research (CDER). Most recently acting CDER director, Galson is a rear admiral in the U.S. Public Health Service. He will oversee more than 2,200 employees who work to evaluate prescription and over-the-counter drugs for their safety and effectiveness.

http://www.fda.gov/bbs/topics/news/2005/new01214.html

 

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

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RECALLS/SAFETY ALERTS

 

D-TRON Adapters, used with D-TRONplus insulin pump

Reason for recall: may deliver excessive insulin dose

http://www.fda.gov/oc/po/firmrecalls/disetronic07_05.html 

 

Two varieties of Merita Harvest Ridge rolls

Reason for recall: undeclared whey

http://www.fda.gov/oc/po/firmrecalls/interstate07_05.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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PUBLIC MEETINGS

Aug. 4 -- Peripheral and Central Nervous System Drugs Advisory Committee
Under discussion: an application for a new drug to treat migraine headaches

Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12543d080405.html 

 

Aug. 9 -- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee

Under discussion: the potential for disease transmission by multiple-use nozzle jet injectors

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12520d080905.html

 

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

 

Is monosodium glutamate (MSG) safe?

 

Monosodium glutamate (MSG) has been used for many years in home and restaurant foods, and in processed foods. People sensitive to MSG may have mild and transitory reactions when they eat foods that contain large amounts of MSG (such as would be found in heavily flavor-enhanced foods).

 

FDA believes that MSG is a safe food ingredient for the general population. It is regarded by the agency as among food ingredients that are "generally recognized as safe." FDA has studied adverse reaction reports and other data concerning MSG's safety. The agency also has an ongoing contract with the Federation of American Societies for Experimental Biology to reexamine the scientific data on possible adverse reactions to glutamate in general. MSG must be declared on the label of any food to which it is added.                                                                                                                                 ___________________________________________________

 

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