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:
On Aug. 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 its weekly Enforcement Report for Aug. 7 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
Evershing International Trading of San Jose, Calif., is voluntarily recalling all ginger candy it imported from Lucky Shing Company in Vietnam due to elevated levels of lead, the Food and Drug Administration announced on Aug. 2. A recent analysis by the California Department of Public Health of the candy found that the product contained lead levels as high as 0.12 parts per million. This concentration could provide up to 10.21 micrograms of lead per serving, the FDA said. According to the FDA, such levels could cause health problems to consumers, especially young children and pregnant women since children under six years of age “should not consume more than 6.0 micrograms of lead per day from all dietary sources.”
The Zip International Group of Edison, N.J., is recalling Baltic sprats in spicy brine because it could potentially be contaminated with the organism Listeria monocytogenes, the Food and Drug Administration (FDA) announced on Aug. 5. The Baltic sprats, originating from Latvia, were sold to distributors and retail grocery stores in the state of N.Y. from May 31 to June 6. The product is in plastic packaging that includes a best by date of Oct. 12. The recall was initiated following a routine sampling by the New York Department of Agriculture & Markets Food Inspectors, where subsequent analysis “found the product to be positive for Listeria monocytogenes."
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).
On Aug. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 5 the Food and Drug Administration posted a new and revised version of the following Import Alerts on the detention without physical examination of: