FDA News Digest for April 17, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

April 17, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- FDA: Benzene Levels in Soft Drinks 'Do Not Pose a Safety Concern'

    -- Agency Supports Decision to Withdraw Contact Lens Solution

    -- FDA Proposal Aimed at Preventing Medical Gas Mix-ups

»  Recalls/Safety Alerts

»  Recent Speeches

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA: Benzene Levels in Soft Drinks 'Do Not Pose a Safety Concern'

Following reports from an FDA food contaminant surveillance program that benzene, a cancer-causing chemical, had been detected at low levels in some soft drinks, FDA surveyed a variety of the beverages using a different testing method. The findings showed that most beverages sampled had either no detectable benzene levels or were well below the U.S. safety threshold for benzene in drinking water. As a result, FDA says benzene levels in soft drinks "do not pose a safety concern."

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01355.html

 

Agency Supports Decision to Withdraw Contact Lens Solution

FDA and the Centers for Disease Control and Prevention are investigating the source of fungal eye infections in some users of soft contact lenses. Meanwhile, FDA is supporting Bausch & Lomb's decision to withdraw its ReNu MoistureLoc contact lens solution from the market until the investigation is complete.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html

-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01357.html

-- More information on contact lenses and eye infections: http://www.fda.gov/oc/opacom/hottopics/contacts.html

 

FDA Proposal Aimed at Preventing Medical Gas Mix-ups

FDA has proposed a rule designed to make the contents of medical gas containers easier to identify, which will help prevent deaths and injuries from accidental use of incorrect or contaminated gas. Medical gases include oxygen, nitrogen, and nitrous oxide, which are administered to patients in healthcare facilities and at home. Over the last 10 years, FDA has received reports of eight deaths and 18 serious injuries linked to medical gas mix-ups.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01353.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

Device Recalls:

 

ICON Modular Fixation System (used in spinal surgery)

    Reason for recall: potential for malfunction

http://www.fda.gov/oc/po/firmrecalls/blackstone04_12.html

 

Ultilet Insulin Syringe (30g 1/2cc)

    Reason for recall: possible bacterial contamination

http://www.fda.gov/oc/po/firmrecalls/bocamedical04_13.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

 

April 5 -- FDA Acting Commissioner Andrew C. von Eschenbach, M.D., spoke at the 4th Annual Meeting of the FDA Alumni Association.

    Subject: FDA and future advances in healthcare

http://www.fda.gov/oc/speeches/2006/fdaaa0405.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

Future meeting:

 

FDA plans a public meeting this fall that will gather information on the use of nanotechnology materials in FDA-regulated products. The agency has not set a date or agenda yet but is asking for input from those interested in attending or presenting at the meeting. Nanotechnology is a science devoted to the design and production of extremely small matter (typically in the realm of 1/1,000th the width of a human hair).

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01356.html 

 

Scheduled meetings:

 

April 18-20 -- 2006 FDA Science Forum; includes sessions on drug safety, obesity, avian flu, and non-invasive medical devices. Also planned is a free public session April 18 called "Ask FDA," in which agency scientists will answer questions from consumers about products FDA oversees.

    Location: Washington, D.C.

http://www.fda.gov/scienceforum

 

April 25 -- Small Pharmaceutical Business Educational Forum

    Under discussion: FDA's pre-market requirements; good manufacturing practices

    Location: Washington, D.C.

http://www.fda.gov/cder/meeting/de-forum-2006.htm

 

April 25-26 -- Cardiovascular and Renal Drugs Advisory Committee

    Under discussion: pending application for a new drug to treat pain associated with anal fissures   

   Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12533dd04252606.html

 

April 28 -- Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum

    Under discussion: FDA's quality systems regulation (especially of interest to small businesses)

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-23677.htm

 

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 

 

How does being overweight or obese affect a person's health?

When people are overweight or obese, they are more likely to develop health problems such as:

• Hypertension
• Dyslipidemia (for example, high total cholesterol or high levels of triglycerides)
• Type 2 diabetes
• Coronary heart disease
• Stroke
• Gallbladder disease
• Osteoarthritis
• Sleep apnea and respiratory problems
• Some cancers (endometrial, breast, and colon)

The more overweight a person is, the more likely that person is to have health problems. Among people who are overweight or obese, weight loss can help reduce the chances of developing these health problems. Studies show that if a person is overweight or obese, reducing body weight by 5 percent to 10 percent can improve one's health*.

For more on losing weight, see http://www.fda.gov/loseweight/

 

*Source: Centers for Disease Control and Prevention

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HOW'S YOUR KNOWLEDGE of health topics such as foot health, migraines, and pain medication? Find out by taking our FDA Consumer health quiz at http://www.fda.gov/fdac/quiz/onlinequiz28_js.html.

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