The Food and Drug Administration issued its weekly Enforcement Report for Aug. 14 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Aug. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 12 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 Aug. 6-12, 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:
On Aug. 9 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 August. 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 is amending its regulations on color additives to allow use of spirulina extract in candy and chewing gum. Effective Sept. 13, the blue-green coloring made from the dried biomass of the cyanobacteria A. platensis will be allowed provided certain conditions are met, including that the color additive not have any microcystin toxin. FDA’s action is in response to a petition filed by Mars, Inc. Written objections and hearing requests are due by Sept. 12.
Federal and local law enforcement agencies arrested seven U.S. and Canadian citizens for importing and distributing allegedly misbranded and unapproved drugs, said the U.S. Attorney’s Office for the Eastern District of Virginia on Aug. 7. A judge issued arrest warrants for three others, and another person facing charges is already in a Canadian prison. According to the attorney’s office, the 11 residents of Virginia, Maryland, Pennsylvania, Michigan, Florida and Canada were associated with Gallant Pharma, a drug company based in Crystal City, Va.
On Aug. 8 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 once again extending the period for comments on its preventative controls (here) and produce safety (here) rules, this time until Nov. 15. The 60-day extension will allow for consideration of the food safety standards in the context of the Foreign Supplier Verification Program (FSVP) and third-party auditor accreditation proposals, published July 29 (see 13072623). “This is the second and final extension of the comment period for these two rules,” FDA said. The agency had already allotted more time for comments in April (see 13042421).