On April 10 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 is approving use of ionizing radiation for control of food-borne pathogens in crustaceans. Effective April 12, FDA will allow irradiation up to a maximum dose of 6 kiloGray to treat chilled or frozen raw, cooked, or partially cooked crustaceans, and dried crustaceans. The National Fisheries Institute had originally requested the change to FDA’s food additive regulations in 2001. Objections or requests for hearings are due May 14.
The Food and Drug Administration reclassifying stair-climbing wheelchairs as Class II devices that do not require premarket approval, in a final rule that takes effect April 14. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling. Stair-climbing wheelchairs will not be exempt from premarket notification requirements.
The Food and Drug Administration recently warned three exporters in South Korea, India, and Thailand that it may begin refusing entry to their fish products because of hazard analysis and critical control point (HACCP) violations. In three separate warning letters, the agency told Seorak Clean Food of South Korea (here), Britto Seafoods of India (here), and Royal Foods of Thailand (here) that their fish products may be placed on import alert if the violations are not corrected. The agency also said that, because the violations are related to food safety, it may assess reinspection fees on each company’s U.S. agent to cover the costs of having to go back to each company’s facility and make sure they are in compliance.
On April 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of March 31 - April 6, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
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.