FDA News Digest
May 19, 2008
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IN THIS WEEK'S ISSUE
» News
-- Cream Cheese, Seafood Operations Closed Following Repeat Violations
-- Texas Seafood Processor Ordered to Shut Down, Recall Products
-- Maker, Distributor of Cough and Cold Products Barred After Violations
» Consumer Health Information
Cream Cheese, Seafood Operations Closed Following Repeat Violations
FDA has announced the shutdown of cream cheese and seafood operations at Illinois-based Lifeway Foods Inc. and its subsidiary, LFI Enterprises Inc., until they comply with food safety laws. Texas Seafood Processor Ordered to Shut Down, Recall Products
FDA has directed Texas-based Hope Food Supply Inc. to shut down and recall all seafood products manufactured from its facility since 2007. An earlier consent decree required the company to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. Because the company has not developed this plan., it cannot restart manufacturing until an FDA-approved HACCP plan is in place. Seafood processors must implement adequate HACCP plans that identify all food safety hazards likely to occur for each kind of seafood product that they process, and set forth preventive measures to control those hazards. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01836.html
Maker, Distributor of Cough and Cold Products Barred After Violations
Scientific Laboratories Inc. and two company executives are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. FDA had warned the company against violating food and drug law and about the risk of enforcement action if it failed to take corrective measures.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01837.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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CONGRESSIONAL TESTIMONY
May 14 -- FDA Center for Food Safety and Applied Nutrition Director Stephen F. Sundlof, D.V.M., appeared before the House Subcommittee on Health
Subject: “Discussion Draft of the ‘Food and Drug Administration Globalization Act’ Legislation: Device and Cosmetics Safety”
http://www.fda.gov/ola/2008/devices051408.html
May 14 -- FDA Associate Commissioner for Science Norris Alderson, Ph.D., appeared before the House Subcommittee on Consumer Affairs, Insurance, and Automotive Safety
Subject: safety of bisphenol-A (BPA)
http://www.fda.gov/ola/2008/bpa051408.html
May 14 -- FDA Statement for the Record before the House Committee on Oversight and Government Reform
Subject: "Should FDA Drug and Medical Device Regulation Bar State Liability Claims?"
http://www.fda.gov/ola/2008/stateliability051408.html
To view an archive of past testimony by FDA officials, go to http://www.fda.gov/ola/listing.html
SAFETY ALERTS/RECALLS
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.] UPCOMING PUBLIC MEETINGS
May 29 -- Dermatologic and Ophthalmic Drugs Advisory Committee
Under discussion: pending application for new drug proposed to treat inflammation and pain following eye surgery
Location: Rockville, Md.
http://edocket.access.gpo.gov/2008/E8-8351.htm
May 30 -- Science Board to FDA
Under discussion: keeping pace with scientific and technical evolutions in regulatory science
Location: Gaithersburg, Md.
http://edocket.access.gpo.gov/2008/E8-10257.htm
May 30 -- Oncologic Drugs Advisory Committee
Under discussion: pending application for a new drug treatment to increase platelet counts and reduce or prevent bleeding in certain patients
Location: Chicago
http://edocket.access.gpo.gov/2008/E8-10258.htm
For a complete list of upcoming meetings, seminars, and other public events sponsored or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
This week's spotlight consumer updates are:
http://www.fda.gov/consumer/updates/asthmameds051308.html
To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.
For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.
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