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The Food and Drug Administration on May 7 released a new draft guidance for industry on requests for exemptions from food allergen labeling.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 FDA’s draft guidance sets out what should be included in petitions for labeling exemptions, like identification information and data from scientific testing. Comments on the draft guidance are due by Sept. 5, said FDA in a concurrent Federal Register notice (here).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:
The Food and Drug Administration will hold a workshop June 5 in Silver Spring, Md. to discuss the guidance development process for medical devices. At the meeting, FDA will discuss with the public best practices in guidance development, as well as how the agency’s Center for Devices and Radiological Health should develop its guidance priorities. Registration is required by May 29 to attend the meeting in person or watch the meeting via webcast.
The number of warning letters issued by the Food and Drug Administration for violations of quality system regulations by medical devices steadily rose between 2009 and 2012, according to data recently released by the agency. That’s partly a result of more inspections, but is also the result of an increased focus on foreign firms, said FDA in the FDA Medical Device 2012 Quality System Data posted to FDA’s website May 2.
Amid explosive growth in imports of drugs and devices from China, the Food and Drug Administration is stepping up its efforts in the country to improve safety, said Christopher Hickey, FDA China director, in a recent blog post. From 2007 to 2013, the total number of FDA-regulated shipments from China to the U.S. nearly quadrupled, said Hickey on April 17. In response, FDA is increasing its staff in China and is improving its collaborative efforts with Chinese regulators, he said.
The proportion of additions to the Food and Drug Administration’s Reportable Food Registry involving imports has fallen each year since the program began in 2009, according to the 4th Reportable Food Registry Annual Report issued May 5. The report on FDA’s listing of human and animal foods that are food safety risks shows first-time entries both imported and domestic at their lowest level since reporting began, although the total number of reports is at its highest level since 2009-10. Undeclared allergens remains the top reason for filing reports, while salmonella in spices was the most common hazard for imports in 2012-13.