In Brief

FDA softens disclaimer for green tea QHC; Formulife/Purus covers spectrum of violations; NAD refers Schick case to FTC; Genomma drops Prestige Brands board bid.

FDA gives sunscreen makers an eleventh-hour extension to comply with new labeling and effectiveness testing requirements. The agency pushed back the deadline by six months for sunscreen products to undergo broad spectrum testing and amend label claims to reflect the test results. Firms now must test and revise packaging by Dec. 17, 2012, for all products with annual sales of $25,000 and up, and by Dec. 17, 2013, for other products, according to a notice in the May 11 Federal Register. FDA extended the deadline after the Consumer Healthcare Products Association and the Personal Care Products Council argued broad spectrum testing for all the sunscreen products would require at least 10 months due to the limited capacity of testing facilities and that complex label redesigns, such as on glass or plastic containers, would take longer than the one year the agency originally granted. Without a delay, the trade groups also argued, firms might pull their products from the market until they complied, which would result in a sunscreen shortage Also see "Industry Needs More Time To Comply With Sunscreen Testing, Labeling Rule" - Pink Sheet, 29 August, 2011..

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Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

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