Tag: FDA
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FDA Issues Guidance on Arsenic in Infant Rice Cereals
The U.S. Food and Drug Administration (FDA) has issued final guidance on inorganic arsenic in rice cereals for infants that sets the action level at 100 micrograms per kilogram, or 100 parts per billion. “FDA has made the determination that this level is achievable based on sampling and testing results,” the guidance states. “This guidance…
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FDA Issues Consumer Update on Milk Allergies and Dark Chocolate
The U.S. Food and Drug Administration (FDA) has issued an update for consumers on its 2018 study examining milk allergies and dark chocolate. “U.S. law requires manufacturers to label food products that are major allergens, as well as food products that contain major allergenic ingredients or proteins,” the update notes. “Allergens contained in a food…
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FDA Releases Draft Guidance on Cannabis Research
The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance that “outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation…
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FDA to Resume Domestic Inspections
The U.S. Food and Drug Administration (FDA) has announced that it will resume domestic inspections of regulated facilities during the week of July 20, 2020, after pausing in March due to COVID-19. “To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining…
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FDA Announces New Era of Smarter Food Safety Blueprint
The U.S. Food and Drug Administration (FDA) has released a blueprint of plans to implement the Food Safety Modernization Act and a hub for the New Era of Smarter Food Safety. The blueprint focuses on four elements: (i) tech-enabled traceability; (ii) smarter tools and approaches for prevention and outbreak response; (iii) new business models and…
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FDA Enters New Phase of FSVP Enforcement
The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due diligence program to review and approve foreign suppliers of imported food. In May 2020, FDA placed two companies on Import Alert 99-41, which is essentially an import ban where…
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FDA Publishes Findings of Leafy Greens E. Coli Investigation
The U.S. Food and Drug Administration (FDA) has published the results of its investigation into an outbreak of E. coli in November and December 2019 caused by romaine lettuce and other leafy greens from the Salinas Valley area of California. FDA found that nearby land used for cattle grazing was the most likely contributing factor…
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FDA Releases Reopening Guidelines for Food Establishments
The U.S. Food and Drug Administration (FDA) has published a food-safety checklist for retail food establishments that have been closed or operating in a limited capacity during shelter-in-place orders. The list covers issues that may arise if a facility has been closed, such as ensuring water and sewage lines or coolers and freezers are working,…