Tag Archives: fda

USA – FDA to Permit the Irradiation of Shellfish

FDA FDA

The U.S. Food and Drug Administration (FDA or we) is amending our current food additive regulations to allow the safe use of ionizing radiation on crustaceans (e.g., crab, shrimp, lobster, crayfish, and prawns) to control foodborne pathogens and extend the shelf life. Our action responds to a food additive petition submitted by the National Fisheries Institute. Our decision is based on a rigorous safety assessment that considered 1) potential toxicity, 2) the effect of irradiation on nutrients, and 3) potential microbiological risk that may result from treating crustaceans with ionizing radiation. The evaluation also considered previous evaluations of the safety of irradiation of other foods including poultry, meat, molluscan shellfish, iceberg lettuce, and fresh spinach. This rule covers raw, frozen, cooked, partially cooked, shelled, or dried crustaceans, or cooked, or ready-to-cook, crustaceans processed with spices or small amounts of other food ingredients.

At the maximum permitted dose of 6.0 kiloGray, this new use of ionizing radiation will reduce, but not entirely eliminate, the number of pathogenic (illness causing) microorganisms in or on crustaceans. The maximum dosage of irradiation approved is capable of reducing a number of pathogens that may be found in crustaceans, including Listeria, Vibrio, and E. coli. Irradiation is not a substitute for proper food-handling practices; therefore crustaceans treated with ionizing radiation must be stored, handled, and cooked in the same way as non-irradiated foods.

 

USA – FDA – Three Salmonella Recalls – Black Peppercorns – Cat Growth Formula – Sweet Basil

FDA

FDA

Frontier Natural Products Co-op is voluntarily recalling several of its products manufactured with organic black peppercorns that were sold under its Frontier and Simply Organic brands, Whole Foods Market 365 Everyday Value, Nature’s Place and others due to potential Salmonella contamination. To date, no illnesses have been associated with these products.

While the product in question was steam pasteurized at the source and tested negative for Salmonella by Frontier Natural Products Co-op, there is a small risk that Salmonella may still be present based on a positive, random test that was recently conducted. Frontier Natural Products Co-op is immediately initiating added precautions to the safety of the supply chain to mitigate any future occurrence.

FDA

The Robert Abady Dog Food Co., LLC of Poughkeepsie, NY, is recalling its 2 lb, 5 lb & 15 lb boxes of “Abady Highest Quality Maintenance & Growth Formula for Cats” because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

The recalled “Highest Quality Maintenance & Growth Formula for Cats” were distributed nationwide in retail stores and through mail orders.

The product comes in a 2 lb, 5 lb & 15 lb, corrugated boxes with plastic liners marked with lot # 14029/21 stamped on the right side top of the box.

No illnesses have been reported to date in connection with this problem.

FDA

Lisy Corporation of Miami, FL is voluntarily recalling Lisy Sweet Basil (Albahaca), 6 oz jar, Item #1132, Lot #’s A013 0518 & A014 0518, because it has the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e. infected aneurysms), endocarditis and arthritis.

No illnesses have been reported to date in connection with this recall.

Lisy Sweet Basil- 6oz, bottle, UPC Code 0 96786 30032 8 began distribution on 01/15/2014 in retail stores in the states of New Jersey, New York, Rhode Island, and Maryland.

USA – Recall Organic Basil – Salmonella

Food Poisoning Bulletin

Infinite Herbs LLC of Miami is recalling 600 units of organic basic because a test by the FDA found Salmonella bacteria. Subsequent testing on other lots did not find any of the Salmonella bacteria. The basil was sold only at Trader Joe’s stores in Florida, Georgia, Louisiana, North Carolina, South Carolina, Southern Virginia, and Tennessee.

The recalled product is Infinite Organic Basil, sold in clear plastic clamshell packages that weigh 2.5 ounces. They were packed on February 21, 2014. The code date is “Date Packed 02/21 20422″. The SKU number is 97197. No illnesses have been reported to date in connection with the consumption of this product.

USA – Microbial Testing Now Required for Infant Formula

Food Poisoning JournalFDA

The U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.

The interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. The interim final rule also establishes current good manufacturing practices specifically designed for infant formula, including required testing for microbial contamination. This microbial testing includes testing representative samples of finished products to prevent the distribution of infant formula products contaminated with the pathogens Cronobacter and Salmonella. The interim final rule also establishes quality factor requirements to support healthy growth.

Companies currently manufacturing infant formula in the United States already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, the FDA will be accepting and reviewing comments on issues or information not previously considered.

The FDA is accepting comments from the public on the interim final rule for 45 days at http://www.regulations.gov (Docket Number FDA-1995-N-0036).

USA – Antimicrobial Soaps Research

FDA

When you’re buying soaps and body washes, do you reach for the bar or bottle labeled “antibacterial”? Are you thinking that these products, in addition to keeping you clean, will reduce your risk of getting sick or passing on germs to others?

Not necessarily, according to experts at the Food and Drug Administration (FDA).

Ingenta Connect

The goal of this research was to conduct a systematic quantitative analysis of the existing data in the literature in order to determine if there is a difference between antimicrobial and nonantimicrobial soaps and to identify the methodological factors that might affect this difference. Data on hand washing efficacy and experimental conditions (sample size, wash duration, soap quantity, challenge organism, inoculum size, and neutralization method) from published studies were compiled and transferred to a relational database. A total of 25 publications, containing 374 observations, met the study selection criteria. The majority of the studies included fewer than 15 observations with each treatment and included a direct comparison between nonantimicrobial soap and antimicrobial soap. Although differences in efficacy between antimicrobial and nonantimicrobial soap were small (∼0.5-log CFU reduction difference), antimicrobial soap produced consistently statistically significantly greater reductions. This difference was true for any of the antimicrobial compounds investigated where n was >20 (chlorhexidine gluconate, iodophor, triclosan, or povidone). Average log reductions were statistically significantly greater (∼2 log CFU) when either gram-positive or gram-negative transient organisms were deliberately added to hands compared with experiments done with resident hand flora (∼0.5 log CFU). Our findings support the importance of using a high initial inoculum on the hands, well above the detection limit. The inherent variability in hand washing seen in the published literature underscores the importance of using a sufficiently large sample size to detect differences when they occur.

USA – FDA Recall – Listeria monocytogenes – Apple Slices

FDAEurofins Food Testing UK

Crunch Pak® of Cashmere, Washington is voluntarily recalling 5,471 cases of
Crunch Pak® Apple Slices due to a possible health risk from Listeria
monocytogenes
.

No illnesses have been reported in association with this recall to date. No other Crunch Pak® products are affected by this recall. FDA is aware that the company is undertaking this voluntary action.

Listeria monocytogenes is an organism that can cause serious
and sometimes fatal infections in young children, frail or elderly people, and
others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The company sold the recalled product to retail customers and because, in some cases, the recalled product was shipped to regional distribution centers, Crunch Pak is taking the extra precautionary measure of issuing this recall nationwide to assure that consumers who may have purchased the product are properly alerted.

USA – FDA Food Code 2013

FDAFDA

Food Code 2013

The Food Code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It represents FDA’s best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service.

This model is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Alternatives that offer an equivalent level of public health protection to ensure that food at retail and foodservice is safe are recognized in this model.

The FDA Food Code marks it’s 20th anniversary with the release of the 2013 edition. The 2013 Food Code (8th edition) reflects the agency’s continued commitment to maintaining cooperative programs with state, local, tribal, and territorial governments. Enhancements in this edition reflect the input of regulatory officials, industry, academia, and consumers that participated in the 2012 biennial meeting of the Conference for Food Protection (CFP).

 

USA – E.coli O157 Outbreak Ready to Eat Salads and Sandwich Wrap Products

E.coli Blog

CDC is collaborating with public health officials in California, Washington, and Arizona; the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS); and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Shiga toxin-producing Escherichia coli O157:H7 (STEC O157:H7) infections.  The STEC O157:H7 PFGE pattern in this outbreak is new to the PulseNet database. It has never been seen before.

FSIS

Glass Onion Catering, a Richmond, Calif. establishment, is recalling approximately 181,620 pounds of ready-to-eat salads and sandwich wrap products with fully-cooked chicken and ham that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The company announced that the products are being recalled in conjunction with other foods regulated by the Food and Drug Administration (FDA). A full list of products being recalled will be available on FDA’s website

USA – FDA Draft on Pathogens in Spices

FDA

In light of new evidence calling into question the effectiveness of current control measures to reduce or prevent illness from consumption of spices in the United States, the United States Food and Drug Administration (FDA) developed a risk profile on pathogens and filth in spices. The objectives of the risk profile were to (1) describe the nature and extent of the public health risk posed by consumption of spices in the United States by identifying the most commonly occurring microbial hazards and filth in spice (2) describe and evaluate current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States (3) identify potential additional mitigation and control options and (4) identify critical data gaps and research needs. The draft risk profile for pathogens and filth in spices provides information for FDA to use in the development of plans to reduce or prevent illness from spices contaminated by microbial pathogens and/or filth.

 

USA – FDA Update – Pet Treat Animal Deaths

FDA

If you have a dog or cat that became ill after eating jerky pet treats, the Food and Drug Administration (FDA) would like to hear from you or your veterinarian.

The agency has repeatedly issued alerts to consumers about reports it has received concerning jerky pet treat-related illnesses involving 3,600 dogs and 10 cats in the U.S. since 2007. Approximately 580 of those pets have died.