FDA News Digest
October 31, 2005
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IN THIS WEEK'S ISSUE
-- FDA Prepares to Combat Potential Bird Flu Pandemic
-- U.S., Mexico, Canada Act to Stop Weight-Loss Fraud
-- Recalls/Safety Alerts
-- Recent Speeches
-- Upcoming Public Meetings
-- Question of the Week
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FDA Prepares to Combat Potential Bird Flu Pandemic
To help ensure that treatments are available in the event of a major U.S. outbreak of bird (avian) flu, FDA has formed a response team to accelerate the stockpiling of antiviral drugs such as Tamiflu. A partnership with industry, academia, and other government agencies, the team also will support development of new treatments and vaccines to protect against bird flu and other potential pandemics.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01248.html
U.S., Mexico, Canada Act to Stop Weight-Loss Fraud
As part of a two-year-old trilateral agreement, the United States, Mexico and Canada have taken more than 700 compliance actions since 2003 against companies that promote bogus weight-loss products. Such actions include recalls, seizures, import refusals, and prosecutions. FDA calls the fight against weight-loss fraud a "key priority" of all three countries.
Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01247.html
Fact sheet: http://www.fda.gov/bbs/topics/NEWS/2005/MUCHfactsheet.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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RECALLS/SAFETY ALERTS
Recalls:
Marzetti Fat-Free Dijon Honey Mustard Dressing; 1.5-oz. packets
Reason for recall: undeclared anchovies
http://www.fda.gov/oc/po/firmrecalls/marzetti10_26.html
Finger Lite Light-Up Candy Necklaces and Light-Up Candy Rings
Reason for recall: high lead content
http://www.fda.gov/oc/po/firmrecalls/malibutoys10_05.html
Safety Alerts:
FDA is alerting the public that Biomedical Tissue Services Ltd. may not have properly screened donors of human skin, bone or tendon tissue for infectious diseases. Because diseases can be transmitted to recipients when tissues are implanted, FDA requires tissue donors to meet eligibility requirements, including tests for HIV-1 and 2, hepatitis B and C, and syphilis. Though no adverse reactions have been reported in recipients of the company's products, FDA says some recipients could be at increased risk of disease.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html
FDA is notifying patients and health professionals that blood glucose meters made by Abbott Diabetes Care can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate reading. This could cause diabetic patients to take the wrong insulin dose or make inappropriate dietary changes --either of which could lead to hyperglycemia (excess blood sugar), a serious and potentially life-threatening condition.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01250.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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RECENT SPEECHES
Oct. 25 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the 2005 Medical Innovation Summit at the Cleveland Clinic Foundation.
Subject: FDA's role in medical technology advances
http://www.fda.gov/oc/speeches/2005/cleveland1025.html
To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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UPCOMING PUBLIC MEETINGS
Nov. 1-2 -- Public Hearing on Direct-to-Consumer Promotion of Medical Products
Washington, DC
Attendance registration is full. Conference center is at capacity.
Nov. 3-4 -- Blood Products Advisory Committee
Under discussion: various topics including West Nile virus and hepatitis C
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516dd11030405.html
Nov. 4 -- FDA Science Board
Under discussion: various topics including FDA's Drug Safety Oversight Board and the Bioresearch Monitoring Initiative
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/fda12603d110405.html
Nov. 7 -- International Conference on Harmonization Workshop on Oncolytic Viruses
Under discussion: issues relevant to clinical development of oncolytic viruses, including safety
Location: Chicago
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19195.htm
Nov. 8 -- Oncologic Drugs Advisory Committee
Under discussion: pending applications for various medical products
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12542d110805.html
Nov. 14 -- Prescription Drug User Fee Act (PDUFA) Public Meeting
Under discussion: stakeholder views as FDA prepares to work on amended authorizing legislation for PDUFA
Location: Bethesda, Md.
http://www.fda.gov/oc/meetings/pdufa111405.html
Dec. 7-8 -- Hearing to obtain public input on the agency's current risk communications and outreach strategies, which include patient information sheets, press releases, public health advisories, and other tools.
Location: Washington, D.C.
http://www.fda.gov/bbs/topics/answers/2005/ans01367.html
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 does the claim "fat free" mean on a food label?
The nutrient content claim "fat free" on a food label means that the serving of food contains an insignificant amount of fat (less than 0.5 grams per serving). Foods labeled fat-free that are naturally fat-free (that is, need no special processing or reformulation to lower fat content) must disclose that fat is not usually present. For example: "broccoli, a fat-free food."
Fat-free or low-fat foods often contain high amounts of added sugars or sodium to compensate for the loss of flavor that occurs when fat is removed. FDA urges consumers to pay close attention to the calories in a single serving to avoid concluding that all fat-free foods are low in calories.
For more information on food labeling, see http://www.cfsan.fda.gov/label.html.
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