Officials from the Food and Drug Administration and the Department of Agriculture recently signed a memorandum of understanding on the regulation of imported and domestic catfish. The memo is “intended to facilitate the transfer of primary regulatory oversight over Siluriformes fish and fish products, including commercial catfish, basa, pangasius, and swai/tra, from FDA” to the USDA’s Food Safety and Inspection Service, said FDA (here).
The Food and Drug Administration is in the process of realigning its Office of Regulatory Affairs (ORA) staff to focus on specific commodities instead of geographic regions, said Howard Sklamberg, FDA deputy commissioner-Global Regulatory Operations and Policy, in a blog post May 9. In a change that appears to echo CBP’s move to the commodity-focused Centers of Excellence of Expertise (CEEs), Sklamberg says FDA’s current geographic model of regional field offices “will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco.”
On May 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On May 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 May 7 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for May. 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.
On May 6 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The Food and Drug Administration on May 7 released a new draft guidance for industry on requests for exemptions from food allergen labeling. Under the Food, Drug and Cosmetic Act, major food allergens like nuts, fish, crustaceans, milk and eggs do not have to be labeled on food if it has been processed in a way that it no longer contains an allergenic protein, or if it is present in such small amounts that it doesn’t present a risk to human health. In these circumstances, companies can request exemptions from FDA for allergen labeling requirements. FDA’s draft guidance sets out what should be included in petitions for labeling exemptions, like identification information and data from scientific testing. Comments on the draft guidance are due by Sept. 5, said FDA in a concurrent Federal Register notice (here).
On May 5 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 April 28 - May 4, 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: