Moon Marine USA Corporation (also known as MMI) of Cupertino, CA is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA, according to the Food and Drug Administration. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak of Salmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths.
On April 12, 2012, 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 released three documents to phase out the use of medically important drugs for feed efficiency or growth promotion in food-producing animals and provide that they be used only for animal health purposes under the supervision of a veterinarian. The three documents include: (1) a final guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, which establishes a framework for phasing out the use of these drugs for feed efficiency or growth promotion and phasing in veterinary consultation or oversight of their medical uses in food-producing animals; (2) a draft guidance, for public comment, to drug companies on how to revise product labels for important antimicrobial drugs to no longer include use for feed efficiency or growth promotion, and include veterinary oversight or consultation; and (3) a draft proposed regulation, also for public comment, amending the regulation that governs veterinary authorization for the use of certain drugs in animal feed.
The Food and Drug Administration said Seng Ong Wholesale, Inc. and Import Foods Wholesale Inc., both of St. Paul, MN, are recalling certain dried and smoked fish products after Minnesota Dept. of Agriculture Laboratory personnel discovered that the products were not properly eviscerated prior to processing. The sale of improperly eviscerated fish, 5 inches in length or greater, is prohibited because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning which may pose a potentially life-threatening health hazard.
On April 11, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Environmental Protection Agency posted premanufacture notices for a new chemical (i.e., a chemical not on the TSCA Chemical Substances Inventory (TSCA Inventory)) received between February 20, 2012, and February 29, 2012, in the Federal Register. Comments are due within 30 days of the notice to docket number EPA-HQ-OPPT-2012-0123 to http://www.regulations.gov, or by mail to Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
On April 10, 2012, 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 said Enesco, LLC is voluntarily recalling the ONIM “Any Wine Will Do” ceramic wine goblets, SKU # 4026171. Enesco is recalling the “Any Wine Will Do” wine goblets because, through its internal compliance and independent laboratory product testing program, it became aware that the wine goblets may exceed the FDA’s guidance levels for leachable lead and cadmium. Enesco sold about 300 of the “Any Wine Will Do” wine goblets to retail stores in AR, CA, CO, FL, HI, IA, IL, IN, KS, KY, MD, MO, MI, MS, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SD, TX, VA, VT, WA and WI. No illness related to this product has been reported. The recall only applies to this item and no other ONIM products are affected.
The Food and Drug Administration announced the availability of a draft guidance for industry entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report," prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The Food and Drug Administration updated its Progress Report on Implementing the Food Safety Modernization Act (FSMA) for January -- March 2012. The report highlights, among other things: (1) the FDA’s announcement of types of foods that will be part of the pilot projects on product tracing; (2) a FAQ and fact sheet describing how FDA identifies a high-risk facility; and (3) the FDA’s release of its interim final rule and guidance on its access to records.