FDA News Digest March 22, 2004 ______________________________________________________________ THIS WEEK'S NEWS -- FDA, EPA Revise Consumer Advice on Mercury Levels in Fish -- Report Seeks to Improve 'Critical Path' of Medical Product Development -- California Firms Agree to Stop Marketing Purported Cure-All 'Seasilver' -- Texas Businessman Pleads Guilty to Selling Illegal Drugs -- Recalls/Market Withdrawals -- FDA Congressional Testimony -- Public Meetings ______________________________________________________________ FDA, EPA Revise Consumer Advice on Mercury Levels in Fish FDA and the Environmental Protection Agency have jointly revised their 2001 consumer advisories on methylmercury levels in fish and shellfish. Though both agencies emphasize that fish can be an important part of a balanced diet, the revised advisory is aimed at reducing exposure to high levels of mercury in women who are or may become pregnant, nursing mothers, and young children. Advisory: http://www.cfsan.fda.gov/~dms/admehg3.html Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01038.html Backgrounder: http://www.fda.gov/oc/opacom/hottopics/mercury/backgrounder.html Report Seeks to Improve 'Critical Path' of Medical Product Development FDA has released a report that identifies problems with and possible solutions to ensuring that innovative medical products reach patients as quickly and inexpensively as possible. The report notes that despite important advances in medical science in recent years, applications to market new medical products have decreased. The reason, says the report, is likely that new science is not being "harnessed" to guide product development -- the so-called "critical path" -- in the same way that it is accelerating the discovery process. Report: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01035.html California Firms Agree to Stop Marketing Purported Cure-All 'Seasilver' Carlsbad, Calif.-based Seasilver USA Inc., and Americaloe Inc., have signed a consent decree in which they have agreed to stop making and distributing products such as "Seasilver," a liquid supplement touted to treat over 650 diseases including cancer, heart disease, and diabetes. Because of these claims, FDA considers Seasilver to be an unapproved drug and in violation of federal law. http://www.fda.gov/bbs/topics/news/2004/NEW01037.html Texas Businessman Pleads Guilty to Selling Illegal Drugs Hadi M. Ghandour, owner of Austin, Texas-based Genapharm Inc., pleaded guilty March 9 to charges that he sold unapproved drugs, including counterfeit human growth hormone, and possessed controlled drugs with intent to distribute. He faces up to five years in prison and a $250,000 fine for each of four counts. http://www.fda.gov/bbs/topics/news/2004/NEW01036.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Harry and David "Raspberry Chocolate Up With the Sun" Breakfast Cookies (undeclared almonds and pecans) http://www.fda.gov/oc/po/firmrecalls/bearcreek03_04.html Sea Specialties Brand Hand-Packed Thin-Sliced Smoked Atlantic Salmon; 4-, 8-, and 16-oz. sizes (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/seaspecialties03_04.html For a listing of recalls, market withdrawals, and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ FDA CONGRESSIONAL TESTIMONY FDA Associate Commissioner for Policy and Planning William K. Hubbard; before the House Committee on Government Reform; subject: Internet drug sales (March 18) http://www.fda.gov/ola/2004/internetdrugs0318.html FDA Office of Device Evaluation Director Daniel G. Schultz, M.D.; before the House Subcommittee on Criminal Justice, Drug Policy, and Human Resources; subject: labeling of condoms (March 11) http://www.fda.gov/ola/2004/condom0311.html To view the text of past FDA testimony, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ PUBLIC MEETINGS April 14 -- Meeting to allow interested people and groups to present information related to how prescription drugs could be imported safely and what the consequences would be for American patients. http://www.fda.gov/OHRMS/DOCKETS/98fr/04-6145.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be March 29. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
