FDA News Digest for September 6, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

September 6, 2005

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IN THIS WEEK'S ISSUE

 

--  New Flu Vaccine OK'd; Chiron Shows 'Significant Progress'

--  Combination Vaccine Covers 4 Common Childhood Diseases

--  Rule Changes Allow Certain Cattle Material in Foods, Cosmetics

--  FDA to Permit Qualified Health Claim for Chromium Picolinate

--  Federal Authorities Shut Down Counterfeit Lipitor Scheme

--  FDA Launches Food Safety Campaign for Moms-to-Be

--  Recalls/Safety Alerts

--  Public Meetings

--  Question of the Week

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New Flu Vaccine OK'd; Chiron Shows 'Significant Progress'

 

FDA has approved Fluarix, a flu vaccine for adults made by GlaxoSmithKline that is expected to help protect the country in the upcoming flu season and help avoid shortages previously seen. Meanwhile, FDA says flu vaccine maker Chiron Corp. has made "significant progress" in addressing compliance issues at its plant in England. But, the agency says, "additional work is needed" before Chiron can market its flu vaccine in the United States.

--  Fluarix information: http://www.fda.gov/bbs/topics/news/2005/NEW01227.html

--  FDA statement on Chiron: http://www.fda.gov/bbs/topics/news/2005/NEW01226.html 

 

Combination Vaccine Covers 4 Common Childhood Diseases

 

FDA has approved ProQuad, a combination vaccine for children aged 12 months to 12 years that can help protect against measles, mumps, rubella, and chicken pox. Because this product combines two separate vaccines -- MMR-II and Varivax -- children being immunized against the four diseases can get one less shot.

--  Labeling information: http://www.fda.gov/cber/label/mmrvmer090605LB.pdf

--  Approval letter: http://www.fda.gov/cber/approvltr/mmrvmer090605L.htm

--  General vaccine information: http://www.fda.gov/cber/vaccines.htm

 

Rule Changes Allow Certain Cattle Material in Foods, Cosmetics

 

FDA has published amendments to a 2004 rule that will allow certain cattle-derived components to be used in human foods and cosmetics. The rule changes permit use of the small intestine, provided that a part of the cow's digestive tract called the distal ileum is removed. The amendments also clarify that cattle-derived milk and milk products, hides and hide-derived products, and tallow, may be used in foods and cosmetics. The agency says the amendments continue to protect against the agent that causes bovine spongiform encephalopathy (BSE), or mad cow disease.

http://www.fda.gov/bbs/topics/news/2005/NEW01229.html 

 

FDA to Permit Qualified Health Claim for Chromium Picolinate

 

Following a review of scientific data, FDA will allow a qualified health claim for chromium picolinate as it relates to type 2 diabetes. The claim, as approved by FDA, reads, "One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain."

http://www.cfsan.fda.gov/~dms/qhccr.html

 

Federal Authorities Shut Down Counterfeit Lipitor Scheme

 

FDA and the U.S. Attorney's Office in Kansas City, Mo., have announced the indictment of distributors and others involved in the sale of counterfeit versions of Lipitor, a top-selling cholesterol-lowering drug. Besides the counterfeit sales, the indictment includes charges of illegal drug importation, misbranding, and sale of stolen drugs.

http://www.fda.gov/bbs/topics/news/2005/NEW01228.html

 

FDA Launches Food Safety Campaign for Moms-to-Be

 

To help educate expectant mothers about the potential risks of foodborne illness, FDA has launched "Food Safety for Moms-to-Be," a public health education campaign in English and Spanish. The campaign includes a comprehensive Web site and a kit for healthcare professionals designed to educate pregnant and soon-to-be pregnant women about the food safety risks of Listeria monocytogenes bacteria, methylmercury, and toxoplasma.   

http://www.cfsan.fda.gov/~pregnant/pregnant.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

 

Trypan Blue 0.06 % Ophthalmic Solution

Reason for recall: possible contamination with Pseudomonas aeruginosa bacteria

http://www.fda.gov/oc/po/firmrecalls/customrx08_05.html

 

Ghiradelli Chocolate Syrup Brownie Premium Mix

Reason for recall: undeclared walnuts

http://www.fda.gov/oc/po/firmrecalls/continental09_05.html

 

1,400 bags of Harry & David's Spiced Apple Almonds

Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/harrydavid08_05.html

 

Classic Sensation and Garden Goodness Honey Dijon Dressings; 16-oz. size

Reason for recall: undeclared milk and egg

http://www.fda.gov/oc/po/firmrecalls/smith09_05.html

 

One lot of Shurfine brand Butterscotch Twirl 1/2-Gallon Ice Cream

Reason for recall: undeclared peanut butter

http://www.fda.gov/oc/po/firmrecalls/shurfine08_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

 

Sept. 8-9 -- Endocrinologic and Metabolic Drugs Advisory Committee

Under discussion: pending application for diabetes treatment

Location: Silver Spring, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12536dd09080905.html

 

Sept. 8-9 -- Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Under discussion: a pending application for a device intended to relieve hip pain and improve hip function

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12521dd09080905.html

 

Sept. 12-14 -- Parenteral Drug Association/FDA Joint Regulatory Conference; an opportunity for collaboration, education, and networking between FDA and the pharmaceutical and biopharmaceutical industries. 

Location: Washington, D.C.

http://www.pda.org/pdafda2005/

 

Sept. 13 -- FDA "Vision 2006" meeting; this is the first in a series of three public meetings aimed at informing consumers about agency programs and getting feedback. Discussion topics will include drug safety, direct-to-consumer advertising, dietary supplements, FDA's "Critical Path" initiative, and the advisory committee process.

Location: Miami, Fla.

http://www.fda.gov/oc/initiatives/vision2006.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

 

Will food that's stored in a freezer for a long period of time be safe to eat?

 

Food that was properly handled and stored at 0° F (-18° C) will remain safe. Only the quality of foods suffers with lengthy freezer storage. Tenderness, flavor, aroma, juiciness, and color of frozen foods can all be affected.     

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