Category: FDA
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FDA Public Meeting to Discuss FSMA Changes
The Food and Drug Administration (FDA) has announced an upcoming public meeting slated for September 19-20, 2013, in Washington, D.C., to discuss regulations proposed under the Food Safety Modernization Act (FSMA) that would establish Food Supplier Verification Programs as well as new rules for accrediting third-party auditors and certification bodies. Intended to ensure “that imported…
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Nonagenarian Researcher Sues FDA for Failing to Ban Artificial Trans Fats
Four years after filing a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a prohibition on the use of partially hydrogenated oils containing artificial trans fat in food for human consumption, 98-year-old University of Illinois Emeritus Professor of Comparative Biosciences Fred Kummerow has filed a lawsuit seeking an order compelling an agency…
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FDA Updates Guidance on Medical Foods
The Food and Drug Administration (FDA) has published draft guidance titled “Frequently Asked Questions About Medical Foods; Second Edition” that provides additional information about the definition, labeling and availability of medical foods—“foods formulated to be consumed or administered orally or enterally under the supervision of a physician.” The first edition of this guidance was issued…
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FDA Approves Color Additive Made from Spirulina
The Food and Drug Administration (FDA) has issued a final rule providing “for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum.” According to FDA, “Spirulina is a blue-green filamentous cyanobacteria that occurs naturally in freshwater and…
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Independent Investigation Claims GRAS Determinations Rife with Conflicts of Interest
A recent study published in JAMA Internal Medicine has faulted the Food and Drug Administration’s (FDA’s) process for declaring food additives “generally recognized as safe” (GRAS), citing alleged financial conflicts of interest among those chosen by companies to verify the safety of new additives. Thomas Neltner, et al., “Conflicts of Interest in Approvals of Additives…
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FDA Seeks More Time to Promulgate Two Food Safety Regulations
The U.S. Food and Drug Administration (FDA) has filed a motion for reconsideration or stay of a court order establishing rulemaking deadlines under the Food Safety Modernization Act. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., Oakland Div., motion filed July 19, 2013). More information about the litigation appears in Issues 481, 487…
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Upcoming FDA Meeting to Discuss Chemical Hazards in Food
The U.S Food and Drug Administration (FDA) has announced a public meeting of the Food Advisory Committee on September 23-24, 2013, in Silver Spring, Maryland. The committee plans to discuss detection signals for chemical hazards in foods, dietary supplements and cosmetics, and review information sources and chemical hazard data. FDA will accept comments until September…
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FDA Proposes Two Rules to Increase Imported Food Safety
The U.S. Food and Drug Administration (FDA) has proposed two rules under the Food Safety Modernization Act (FSMA) for verifying foreign suppliers and accrediting third-party auditors. Part of the agency’s effort “to ensure that imported food meets the same safety standards as food produced in the United States,” the proposed rules would (i) require importers to verify “that their foreign suppliers…