Yesterday, September 23 2008 FDA finally launched a long awaited crackdown against companies marketing prescription medications without government approval.
The NEW™ Institute involvement with the skin cream containing papain, derived from the tropical papaya plant, provided evidence that manufacturers were selling it without federal validation of their safety and efficacy.
The cream is being touted by about a dozen of manufacturers for treatment of chronic (non-healing) skin ulcers from diabetes and other causes.
As of today, there is no single approved version of such cream in a "business" worth about $50 million a year.
The adverse reporting noted that frequently the cream was of no help to patients and caused life-threatening allergiс reactions.
Companies making this unapproved cream have till November 24 to file for FDA approval or cease production in lieu of FDA seizures and other legal actions.
Be Well!
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