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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FTC advertising guides: Revised final 1guidance from the Federal Trade Commission, effective Dec. 1, tightens up the commission's guidelines for using endorsements and testimonials in advertising, including blog posts. Under the revisions, when ads portray a consumer whose experience with a product is not typical, the advertiser must also disclose what results can generally be expected. The "results not typical" disclaimer is no longer allowed. Endorsers are also liable for false or unsubstantiated claims, or for failing to disclose financial ties with the advertiser, FTC clarifies. New examples address, among other things, what constitutes an endorsement in a blog post. Also, if a company references a research organization's findings from a company-sponsored study, the ad must convey that connection, the commission noted. FTC's endorsements and testimonials guides were last updated in 1980

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Cardiac Science AEDs: Cardiac Science initiated a field correction Nov. 13 on several models of its Powerheart and CardioVive automated external defibrillator devices that may not delivery therapy during a resuscitation attempt. AED display screens and audible indicators may not accurately indicate whether the device is functioning properly, FDA notes in a Nov. 19 safety communication. About 300,000 devices are potentially affected, and a software correction will not be available until May 2010. Cardiac Science recommends customers leave their AEDs in service, but FDA urges users to seek alternative products, if possible. The company stopped production on some Powerheart AEDs in late June after discovering a resistor malfunction, but resumed shipments Aug. 10. AEDs produced since August are unaffected, the firm stresses. The company earlier predicted that the quality issues could cost upwards of $20 million to resolve (1"The Gray Sheet" Aug. 17, 2009)

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