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Health Highlights: Sept. 19, 2007

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Under a Grocery Manufacturers Association proposal, the Food and Drug Administration would oversee a program to ensure that imported foods meet U.S. safety and quality standards and Congress would give the FDA enough funding to do the job, theAssociated Pressreported.

The association also wants to establish a system to expedite processing of imports that have been pre-cleared by the FDA. This would be achieved, in part, by having companies share in confidence test results and other data about those imports with the FDA.

This would enable the FDA to devote more resources to imports from sources deemed to be at high risk, the association said. Currently, the FDA inspects less than one percent of all food imports, theAPreported.

The proposal was welcomed by lawmakers and consumer groups who say that the FDA is unable to adequately monitor food imports.

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FDA Recalls Defibrillators

A Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators has been issued by the U.S. Food and Drug Administration. A Class I recall, the most serious type, involves situations where there's a reasonable probability that the use of a product will cause serious injury or death.

AEDs are used by emergency or medical personnel to treat people having a heart attack.

The AEDs in this recall were made between October 2003 and January 2005, with serial numbers 205787 through 207509. These AEDs may show a "Defib Comm" error message on the device display during use which may result in terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy, the FDA said.

Anyone with the recalled devices should stop using them and contact Welch Allyn for a replacement. The company can be reached at 1-800-462-0777.

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FDA Warns Proctor & Gamble About Hand Sanitizer Claims

The U.S. Food and Drug Administration on Tuesday ordered Proctor & Gamble to stop advertising that its Vicks Early Defense foaming hand sanitizer prevents the spread of viruses that cause colds,Bloomberg Newsreported.

There is not enough evidence to show the product is safe for such use, according to a warning letter posted on the FDA's Web site. The agency made specific reference to Proctor & Gamble's promotion of Early Defense for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours.

The FDA ordered Proctor & Gamble to correct the violations or face legal action, seizure or an injunction,Bloombergreported.

The active ingredient in Early Defense is triclosan, which is covered under FDA regulations for certain antiseptic uses. Those regulations do not include Proctor & Gamble's directions that users should leave the Early Defense product on their hands, without rinsing with water.

"We believe we're within the FDA guidelines, and we're going to work with the FDA to clear up any misunderstandings," said Proctor & Gamble spokesman David Bernens,Bloombergreported.

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Stem Cell-Derived Lung Cells Successfully Implanted in Mice

U.K. scientists grew lung cells from mouse embryo stem cells and successfully implanted them in the lungs of mice. This "global breakthrough" suggests that someday it may be possible to use this kind of approach to treat lung disease in humans,Agence France-Pressereported.

In this study, scientists injected embryonic stem cell-cultivated lung cells into the lungs of mice. When the mice were examined two days later, the researchers found that the injected lung cells had lodged in the rodents' lungs.

This demonstrates the "high degree of specialization of these cells, which attach only to their target organ, ie, the lungs," the researchers said. The finding "opens up exciting new horizons for the treatment of lung disease."

The study was presented at the European Respiratory Society's annual meeting in Stockholm,AFPreported.


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