October 23, 2016

FDA Found Listeria Monocytogenes at Jeni’s Splendid Ice Cream

The FDA sent a warning letter to Jeni's Splendid Ice Cream's frozen flavor base Ohio manufacturing facility on August 9, 2016. The inspection that prompted the letter took place on January 25, 2016 through February 9, 2016. That letter states that "your frozen flavor base products are adulterated" because "FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. " A recall of Jeni's Splendid Ice Creams was initiated for possible Listeria monocytogenes contamination in April, 2015. All of the company's ice cream, frozen yogurt, sorbet, and ice cream sandwiches in all flavors and containers were recalled, and all scoop shops were closed. No illnesses were ever reported in connection to these … [Read more...]

FDA Extends FSMA Compliance Dates

The FDA is setting the first major compliance dates for the Food Safety Modernization Act of 2011 for large food facilities. The agency also issued a final rule that "extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules." The final rule addresses technical issues and aligns compliance dates across the four rules. Human food companies, other than small and very small businesses, need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by September 19, 2016. This rule creates new requirements for the production of human food in three ways. First, certain domestic and foreign facilities must implement hazard analysis and risk-based preventive … [Read more...]

FDA Finds Hepatitis A in Sea Port Products Scallops

The FDA has found hepatitis A in two samples of Sea Port Products Corporation scallops that are at the center of the outbreak in Hawaii. On August 17, the analysis came back positive. The samples were collected on August 11, 2016. The tests were the result of a hepatitis A outbreak in Hawaii that has sickened at least 206 people. Fifty-one people are hospitalized because their illnesses are so severe. That outbreak has been ongoing since the June 12, 2016 and more cases are being diagnosed each week. The FDA is supporting the Hawaii Department of Health in the investigation. Those scallops were distributed to California, Hawaii, and Nevada but were not sold directly to consumers; they were sold to restaurants and other facilities. Yesterday, Sea Port issued a voluntarily recall … [Read more...]

FDA to Publish Final Rule on GRAS; Experts Object

The FDA is publishing its final rule on GRAS (generally recognized as safe) substances in human and animal food tomorrow. The rule "amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the FD&C Act because it is generally recognized as safe under the conditions of its intended use." Ingredients on the GRAS list don't need to be approved by the FDA before they are added to foods, but they must adhere to the same safety standards as approved additives. The GRAS list includes substances that were in use in foods before 1958, or through scientific procedures. But food safety experts are concerned about the rule and think that it gives companies the power to make … [Read more...]

FDA Issues Revised Draft Guidance to Improve Supplement Safety Notifications

The FDA issued a revised draft guidance on August 11, 2016 to improve dietary supplement companies' new dietary ingredient (NDI) premarket safety notifications to the government. These notifications help the FDA identify safety concerns before consumers buy these products. The Dietary Supplement Health and Education Act (DSHEA) requires a manufacturer or distributor to notify the FDA at least 75 days before marketing a supplement that contains a new dietary ingredient, unless the NDI is used in the food supply without chemical alteration. A new dietary ingredient is one that was not marketed in the U.S. before October 15, 1994. Supplements are considered adulterated if they contain an NDI not used in the food supply and if notification has not been submitted to the FDA 75 days … [Read more...]

Learn How to Select and Serve Produce Safely

Summer is a time when everyone enjoys eating more fresh produce. But there have been many foodborne illness outbreaks in the past few years linked to fresh fruits and vegetables. Some of the pathogens in those outbreaks include Salmonella, E. coli, Listeria monocytogenes, and cyclospora. The FDA is offering tips to help you choose and serve fresh produce safely. Harmful bacteria can be in the irrigation water used in the fields. Animals can poop on the plants, transferring pathogenic bacteria onto the fruits and vegetables. Product can also be contaminated during harvest, processing, or transport. When you buy produce, always choose products that are not damaged, cut, or bruised. Those injuries are open doorways to pathogens. Once the pathogens are inside the fruit or vegetable, … [Read more...]

Senator Schumer: FDA Needs to Fix Recall Process

Senator Chuck Schumer (D-NY) is calling on the federal government to improve the FDA's ability to recall contaminated foods. He uses the recall of millions of pounds of General Mills flour for potential E. coli contamination as an example. The E. coli O121 and O26 outbreak linked to that flour began in December 2015, but the flour itself was not recalled until May 2016. Meanwhile, more American consumers got sick. The Senator called for major changes, to make sure the FDA is doing everything it can to prevent future foodborne illness. The Senator is responding to a recently released report by the Office of Inspector General for the U.S. Department of Health and Human Services, which suggested that the FDA is taking far too long to initiate food recalls, putting consumers at … [Read more...]

General Mills Flour Outbreak Now Includes Two Strains of E. coli

The General Mills flour E. coli outbreak now includes two strains of the bacteria: E coli O121 and E. coli O26.  Initially, only one strain, E. coli O121, was linked the outbreak, which now includes 46 cases in 21 states. But, whole genome sequencing  tests performed by the U.S. Food and Drug Administration (FDA) identified the second strain. Like their better-known relative E.coli O157:H7,  E. coli O26 and E. coli O121 produce shiga toxins that can cause serious illness. In this outbreak, 13 people have been hospitalized and one of them has developed hemolytic uremic syndrome, (HUS) a life-threatening complication of E. coli infections that leads to kidney failure. The new finding prompted General Mills to expand its recall of flours possibly contaminated with E. coli. On May 31, … [Read more...]

How Much Salt Do You Really Eat?

The FDA is warning consumers that they may be consuming far more salt than they think. Even if you don't salt your food at the table or while cooking, you are probably consuming a lot of sodium, especially if you eat prepared or processed foods. Most of the sodium in the American diet comes from supermarket foods and restaurant meals. So the FDA is working to gradually reduce the amount of sodium that processors add to food. Draft guidance for industry has been released that sets voluntary goals for reducing sodium levels in processed and prepared foods. Note that their guidance is voluntary, which means that processors and restaurants do not have to abide by the levels. The maximum sodium intake per day for adults should be about 2,300 milligrams, which is the amount in a … [Read more...]

FDA Releases Commodity Sampling Test Results on Raw Milk Cheese

The FDA released test results of commodity sampling last week. The products sampled were raw milk cheese aged 60 days, cucumbers, and hot peppers. This sampling program is part of an effort to help ensure food safety. This program was adopted in 2014 to learn more about the prevalence of disease-causing bacteria in foods and to help the agency identify patterns to help prevent future contamination. Raw milk cheese aged 60 ways was one of the commodities selected for the first year of testing. Evidence indicates that aging this product for 60 days may not eliminate or adequately reduce disease causing bacteria, posing a hazard. After testing 1,606 samples in 2014 and 2015, FDA found raw milk cheese aged 60 days or more has less than one percent contamination rate for Salmonella, … [Read more...]

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