FDA News Digest for February 21, 2006

[FDA News Digest]

Title: Message

FDA News Digest

February 21, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- FDA to Allow Clinical Studies of Withdrawn MS Drug Tysabri

    -- Agency Defines Term 'Whole Grain' for Use on Food Labels 

    -- Biomarker Initiative Aims to Speed Cancer Therapy Development

    -- New Treatment Approved for Certain Serious Fungal Infections

    -- Unsanitary Conditions Prompt Seizure from D.C. Food Warehouse

»  Latest FDA Consumer Magazine Available Online 

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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FDA to Allow Clinical Studies of Withdrawn MS Drug Tysabri

FDA will permit clinical trials of the multiple sclerosis treatment Tysabri to resume, though concerns remain about the drug's potential risks. One year ago, these concerns caused FDA to suspend clinical trials of Tysabri, and the drug was taken off the market. However, Tysabri has shown to be beneficial for certain patients, who will now be allowed to resume treatment in controlled studies after discussing potential risks and benefits with their doctors.

http://www.fda.gov/bbs/topics/news/2006/NEW01319.html

 

Agency Defines Term 'Whole Grain' for Use on Food Labels

FDA has issued guidance for companies that use the term "whole grain" on their food product labels. The agency considers whole grain to be intact, ground, cracked or flaked cereal grains (such as oats, corn, rice and wheat) that contain endosperm, germ and bran in the same proportion as in the intact grain.

http://www.fda.gov/bbs/topics/news/2006/NEW01317.html

 

Biomarker Initiative Aims to Speed Cancer Therapy Development

FDA is joining with the National Cancer Institute and the Centers for Medicare and Medicaid Services to help improve development and delivery of new cancer therapies. The joint agreement, called the Oncology Biomarker Qualification Initiative, will center on use of biological indicators called "biomarkers" to develop targeted cancer diagnostics and treatments.

http://www.fda.gov/bbs/topics/news/2006/NEW01316.html  

 

New Treatment Approved for Certain Serious Fungal Infections

FDA has approved Eraxis, a treatment for certain infections caused by Candida, a fungus that can cause serious infections in hospitalized patients or in people with compromised immune systems. FDA calls the treatment "a helpful addition to the available antifungal medications that can be used in the treatment of these potentially serious fungal conditions."

http://www.fda.gov/bbs/topics/news/2006/NEW01321.html

 

Unsanitary Conditions Prompt Seizure from D.C. Food Warehouse

U.S. marshals have seized various food items from Happy Valley Food Inc. after FDA inspectors found several violations, including rodent infestation and overcrowded storage conditions in the company's Washington, D.C, warehouse. FDA has taken action against Happy Valley Food before, including a 1996 seizure and a 2001 warning letter outlining unacceptable storage conditions.

http://www.fda.gov/bbs/topics/news/2006/NEW01320.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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Latest FDA Consumer Magazine Available Online

The latest issue of FDA Consumer is devoted to the 100th anniversary of the signing of the Pure Food and Drugs Act, a milestone often viewed as the beginning of what became the Food and Drug Administration. Articles in the magazine are on these topics:

 

--  Ensuring safe foods and cosmetics

--  Promoting safe and effective drugs for 100 years

--  FDA law enforcement

--  How cutting-edge science promotes public health

--  Harvey W. Wiley, "the father of the Pure Food and Drugs Act"

--  Animal health and consumer protection

--  The road to the biotech revolution

--  Medical device, radiological health regulations come of age

--  FDA research: foundation for regulatory decisions

--  FDA goes worldwide

 

The issue is online at http://www.fda.gov/fdac/106_toc.html.

 

Subscribe to the print version of FDA Consumer:  http://www.fda.gov/fdac/orderform/fdap.html

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RECALLS/SAFETY ALERTS

 

Food Recalls:

 

Twisted Snails Frozen Danish Dough

    Reason for recall: undeclared soy

http://www.fda.gov/oc/po/firmrecalls/bestbrands02_06.html

 

La Preferida whole pinto beans; 15-oz. size

    Reason for recall: bird's head found in a can of the product

http://www.fda.gov/oc/po/firmrecalls/lapreferida02_06.html

 

Three types of Carpathian brand Tobiko caviar; 2-, 4-, and 8-oz. sizes

    Reason for recall: undeclared soybean

http://www.fda.gov/oc/po/firmrecalls/flyingsalmon02_06.html

 

Marito's Bakery's Keikitos (muffins); 8-oz. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/marito02_06.html

 

Safety Alert:

 

Following reports of rare cases of serious side effects in users of the antibiotic Tequin (gatifloxacin), the drug's maker is strengthening warnings in the product's labeling. Approved in 1999, Tequin is used to treat patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections.

http://www.fda.gov/bbs/topics/news/2006/NEW01318.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

 

Feb. 27 -- Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee)

    Under discussion: updates on various studies

    Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/nctr12560d022706.html

 

April 18-20 -- 2006 FDA Science Forum; includes sessions on topics such as drug safety, obesity, avian flu, and non-invasive medical devices.

    Location: Washington, D.C.

http://www.fda.gov/scienceforum

 

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

 

What is the difference between an over-the-counter (OTC) drug product and a cosmetic?

Food and drug law defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Among the products included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Products intended to treat or prevent disease, or otherwise to affect the structure or functions of the human body, are considered drugs. Over-the-counter (OTC) drugs are products that can be bought without a doctor's prescription. Examples include fluoride toothpastes, sunscreen preparations, antiperspirants, and antidandruff shampoos.

Want to know more? See http://www.cfsan.fda.gov/~dms/cos-218.html. __________________________________________________________

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