FDA News Digest for May 19, 2008

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FDA News Digest May 19, 2008 ___ 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 » Congressional Testimony » Safety Alerts/Recalls » Upcoming Public Meetings » Consumer Health Information ________ NEWS 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. The action follows a history of violations of food and drug law dating back to at least 2004. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01835.html 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 view an archive of recent 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.] ___________ 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 “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 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 "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. CONSUMER HEALTH INFORMATION This week's spotlight consumer updates are: › FDA Safety Update: Asthma Medications http://www.fda.gov/consumer/updates/asthmameds051308.html › Drug Approved for Irritable Bowel Syndrome http://www.fda.gov/consumer/updates/ibsdrug050108.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. Thanks for subscribing to FDA News Digest. Our next issue will be sent May 27. Comments about FDA News Digest? Send an e-mail to fdanewsdigestv. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420