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FDA Posts Draft Guidance on Honey Labeling
April 8, 2014 by Brian Feito|FDA

The Food and Drug Administration announced on April 8 a new draft guidance document on labeling of honey and honey products. The draft guidance includes a question and answer section that addresses how to label pure honey, blends of honey and a sweetener, and honey with flavoring ingredients. To ensure consideration before FDA finalizes its guidance, comments are due by June 9, according to a concurrent Federal Register notice (here).

FDA Cites New York Fish Importer for HACCP Violations
April 7, 2014 by Brian Feito|FDA

The Food and Drug Administration threatened action against a New York fish importer because of alleged violations of seafood hazard analysis and critical control point (HACCP) regulations. FDA’s March 20 warning letter said the agency had already in November 2013 found decomposition in a shipment of frozen vacuum packed raw ground tuna imported by Best Choice Trading in Brooklyn. A subsequent inspection in February allegedly found HACCP violations, FDA said. The agency said it will now conduct a reinspection to see if Best Choice has brought itself into compliance, and may assess fees on Best Choice to cover reinspection costs.

FDA Threatens GlaxoSmithKline, Smuthri With Refusal of API Imports
April 7, 2014 by Brian Feito|FDA

The Food and Drug Administration told two drug companies in separate warning letters it will refuse entry of their active pharmaceutical ingredients (APIs) unless they correct violations of current good manufacturing practice requirements (CGMP). In a letter dated March 18 sent to GlaxoSmithKline (here), FDA said CGMP violations at the company’s Cork, Ireland facility may result in APIs from that facility being placed on import alert and being refused admission. Meanwhile, an agency warning letter dated March 6 told Smruthi Organics in India that its APIs will continue to be refused admission into the U.S. because of persisting CGMP violations (here).

FDA Adopts Interim Regulations on Access to Food Records
April 3, 2014 by Brian Feito|FDA

The Food and Drug Administration issued a final rule adopting in full its interim regulations expanding the agency’s access to food records. FDA had implemented the Food Safety Modernization Act recordkeeping changes in a February 2012 interim final rule (see 12022320). Under the now-adopted interim regulations, FDA not only has the right to access company records on an article of food that presents a food safety risk, but also any article FDA “reasonably believes” is affected in a similar manner, as well as any food for which FDA believes there is a “reasonable probability” of food safety risks.