The Food and Drug Administration is amending its regulations on color additives to allow use of spirulina extract in more types of foods. In response to a petition from GNT USA, the agency will effective May 13 allow use of the cyanobacteria-derived blue coloring in color frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals (excluding extruded cereals). FDA already allows use of spirulina in candy and chewing gum (see 13081214). Objections and hearing requests are due May 12.
On April 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for April. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
The Food and Drug Administration announced on April 8 a new draft guidance document on labeling of honey and honey products. The draft guidance includes a question and answer section that addresses how to label pure honey, blends of honey and a sweetener, and honey with flavoring ingredients.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).
On April 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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.
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).
On April 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: