FDA News Digest for July 31, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest     

July 31, 2006

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IN THIS WEEK'S ISSUE

»  News

    --  FDA Announces Framework for Moving Contraceptive Plan B to OTC Status

    --  FDA Expands Approval of Leukemia Drug Oncaspar

    --  ALERT Aims to Raise Awareness of Food Defense Issues

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Announces Framework for Moving Contraceptive Plan B to OTC Status

FDA has announced it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B without a prescription.  Plan B is often referred to as emergency contraception or the "morning-after pill."

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01421.html

 

FDA Expands Approval of Leukemia Drug Oncaspar

FDA has approved the chemotherapy drug Oncaspar to include treating children and adults with newly diagnosed acute lymphoblastic leukemia as part of a multi-drug regimen. Oncaspar was originally approved in 1994 but for a narrower group of patients. The expanded approval will allow patients on current therapy to reduce the number of injections from 21 to three.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01419.html

 

ALERT Aims to Raise Awareness of Food Defense Issues

FDA has joined with several government and private organizations to announce ALERT, an initiative designed to heighten awareness of food defense. An acronym that stands for Assure, Look, Employees, Reports, and Threat, ALERT poses five basic questions that can help decrease the risk of intentional contamination at a food facility. The ALERT initiative can be applied at any point in the food supply chain, from farm to retail establishment.

http://www.cfsan.fda.gov/~dms/alert.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 Recalls: 

 

2,700 bags of Harry & David Chocolate Covered Pear Bites; 8 oz. size

    Reason for recall: may contain undeclared almonds, eggs and wheat

http://www.fda.gov/oc/po/firmrecalls/harrydavid207_06.html

 

Sunny Lake Trading's Dried Potato; 6 oz. size

    Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/sunnylake07_06.html

 

Safety Alerts:

 

FDA is warning consumers not to drink high-strength hydrogen peroxide products for medicinal purposes, especially a product marketed as "35 Percent Food Grade Hydrogen," which has been advertised as a treatment for AIDS, cancers, emphysema, and other diseases. Such products taken orally can cause serious harm or death, the agency says.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01420.html

 

FDA has informed manufacturers and suppliers of soft vinyl lunchboxes that analytical tests have shown the presence of lead in certain flexible lunchboxes. The agency is urging companies to stop marketing these products. Though the amount of lead that may transfer to food is likely small, adverse effects can occur at even low exposures because lead accumulates in the body. 

http://www.cfsan.fda.gov/~dms/pbltr2.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.

 

Note: FDA has created a free e-mail list that allows you to receive press releases about recalls of FDA-regulated products. The list covers only Class 1 (life-threatening) recalls. To sign up, go to http://list.nih.gov/cgi-bin/wa?SUBED1=fda-recalls-l&A=1. 

 

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

 

July 27 -- FDA Office of In Vitro Diagnostic Device Evaluation and Safety Director Steven Gutman, M.D., testified before the Senate Special Committee on Aging.

     Subject: regulation of in vitro diagnostic devices

http://www.fda.gov/ola/2006/ivd0727.html 

 

July 26 -- FDA Office of New Drugs Deputy Director Sandra L. Kweder, M.D., testified before the House Subcommittee on Criminal Justice, Drug Policy and Human Resources

    Subject: FDA efforts to curb prescription drug abuse

http://www.fda.gov/ola/2006/rxdrugabuse0726.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

 

Aug. 23-24 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: industry and FDA perspectives on proper conduct of FDA-regulated clinical trials

    Location: Brooklyn Park, Minn.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8896.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 does FDA regulate infant formulas?

FDA ensures the safety and nutritional quality of infant formulas by requiring that companies follow specific manufacturing procedures. In fact, a law -- known as the Infant Formula Act -- was passed in 1980 giving FDA special authority to create and enforce standards for commercial infant formulas. Manufacturers must analyze each batch of formula to check nutrient levels and product safety. They then must test samples to make sure the product remains in good condition while it is on the market shelf. Infant formulas also must have codes on their containers to identify each batch, and manufacturers must keep very detailed records of production and analysis.

 

For more on infant formulas, see http://www.cfsan.fda.gov/~dms/inf-toc.html.

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