FDA News Digest for December 15, 2003

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FDA News Digest

December 15, 2003

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Draft Advisory Updates Recommendations on Methylmercury in Fish

FDA has released a draft advisory containing revised recommendations

regarding fish and shellfish consumption for people at risk from exposure to

the high methylmercury levels found in certain fish varieties. Groups at

risk include pregnant women, nursing mothers, women who may become pregnant,

and young children. The recommendations were discussed at a meeting Dec.

10-11 of the FDA Food Advisory Committee.

Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01270.html

Draft advisory: http://www.fda.gov/oc/opacom/mehgadvisory1208.html

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New Lab Culture Test for Identifying Anthrax Cleared for Marketing

FDA has cleared for marketing the Redline Alert, a test kit for clinical

laboratories to use with culture testing to help distinguish the organism

that causes anthrax disease from similar organisms. Designed to be used with

other laboratory tests, the Redline Alert can be performed in about 15

minutes and does not require specially trained personnel or special

instrumentation.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00992.html

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Injectable Gel Approved for Treating Facial Wrinkles

FDA has approved the injectable gel Restylane as a treatment for filling

moderate-to-severe wrinkles around the nose and mouth. Restylane is the

third injectable product approved for treating facial wrinkles.

http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01271.html

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Guide Explains FDA, Customs Policy on Food Import Compliance

FDA and the U.S. Bureau of Customs and Border Protection have issued a guide

that describes how the two agencies plan to maintain an uninterrupted flow

of food imports while improving food safety as part of the provisions of the

Bioterrorism Act of 2002. Under the Act, FDA must receive prior notice of

all human and animal food, drinks, and dietary supplements imported or

offered for import to the United States.

Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00995.html

Compliance Policy Guide: http://www.cfsan.fda.gov/~pn/cpgpn.html

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Drug, Biologic Sponsors Now Required to Submit Labeling Electronically

FDA has revised regulations to require that proposed labeling for certain

drugs and biologics be submitted to the agency electronically as part of

applications for approval of those products. This standardized format will

allow FDA to ensure that information provided by product sponsors is

accurate and to communicate information that doctors and patients need to

use products.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00991.html

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FDA Reaffirms Hepatitis A Link to Raw Green Onions

FDA, along with the Centers for Disease Control and Prevention and state and

local health officials, have confirmed that several recent outbreaks of

hepatitis A have been linked to eating contaminated raw or undercooked green

onions (scallions) traced to Mexico. Though the exact source of the

contamination has not been determined, FDA is continuing its investigation

in cooperation with the Mexican government.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00993.html

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FDA Decides Not to Regulate Aquarium 'Glofish'

FDA has issued a statement saying that because tropical aquarium fish are

not used for food purposes, it will not regulate the genetically engineered

zebra danio fish called " Glofish. " The agency says there is no evidence

that Glofish pose any more threat to the environment than the unmodified

species sold widely in the United States.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00994.html

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FDA Honors W. Leigh for Work in Medicine, Public Health

For accomplishments in a career spanning nearly four decades, W. Leigh

, M.D., has been awarded the FDA Commissioner's Special Citation.

The honor cites 's work in critical care, pharmaceutical development

innovations, information technology management, and collaborations with

regulators.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00996.html

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RECALLS/MARKET WITHDRAWALS

The following products are being recalled for the reasons shown. Go to the

linked page for more information.

Lucerne Chocolate Almond Ice Cream (undeclared peanuts)

http://www.fda.gov/oc/po/firmrecalls/safeway12_03.html

Stop & Shop Assorted Party Cookies (undeclared milk and nuts)

http://www.fda.gov/oc/po/firmrecalls/stopshop12_03.html

Atlantis Salmon Spread, Chicken Salad (possible Listeria monocytogenes

contamination)

http://www.fda.gov/oc/po/firmrecalls/atlantis12_03.html

Wisconsin Cheesecake Co. Candy Bar Cheesecakes (undeclared peanuts)

http://www.fda.gov/oc/po/firmrecalls/wisconsinccake12_03.html

Asian Boy Dried Ginger (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/BCN12_03.html

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PUBLIC MEETINGS

For a list of upcoming FDA meetings, seminars, and other public events, go

to

http://www.fda.gov/opacom/hpmeetings.html.

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HOW'S YOUR KNOWLEDGE of health-related topics such as heart disease,

genetically engineered foods, and menopausal hormone therapy? Find out by

taking our quiz at http://www.fda.gov/fdac/quiz/onlinequiz14_js.html.

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