US FDA Turns To Temporary Enforcement Discretion For Boosting Infant Formula Supply
Agency Also Allows Abbott Facility To Restart Production Under Consent Decree
FDA launches temporary enforcement discretion on infant formula product to help increase supply in US on same day consent decree announced to allow Abbott to restart production at facility closed since February, prompting ongoing formula shortage.
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“We don't have to look much further than our consumer complaint and adverse event systems to see that these upgrades are needed. Each year we receive nearly 10,000 consumer complaints and adverse event reports regarding FDA regulated foods and dietary supplements,” says Susan Mayne.
FDA immediate actions include ensuring providers know they’re required to develop redundancy risk management plans, enhancing inspections of manufacturers, including by expanding and improving training for investigators, and expediting reviews of premarket submissions for new products.
“This system is fundamentally prone to supply chain disruptions with so few manufacturers,” says Mark Moorman, FDA Office of Food Safety director. In FDLI presentation, he acknowledges delicate balance in stemming distribution of potentially contaminated power formula while sustaining supply.