November 26, 2015

FDA Warning Letter to Frito-Lay’s Tennessee Facility

The FDA has sent a warning letter to Frito-Lay's Tennessee facility, sating that inspections in May and June 2015 "revealed serious violations of FDA's Current Good Manufacturing Practice requirements." That means food products held at that facility are considered adulterated because they were "prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health." Frito-Lay has responded to Form FDA 483, and included a number of corrective actions. The adequacy of those actions will be assessed during the next inspection. The inspections in May and June revealed that the roof was leaky, often directly over exposed product through the facility. The equipment wash and sanitize bay, walls, and floor in the pretzel … [Read more...]

Whole Leaf Stevia Isn’t Considered GRAS

Many foods contain a chemical from Stevia, which is a herb that is very sweet and doesn't add calories to food. It is considered a sugar substitute, the only one made from a plant (not in a factory) and it is 200 times sweeter than sugar. But in a warning letter to the Ten Ren Tea Company of San Francisco, the FDA told them that whole leaf Stevia is not on the generally regarded as safe (GRAS) list. Whole Stevia leaves and "crude Stevia extracts" are not approved as food additives. The FDA has received petitions for the use of whole-leaf Stevia and its crude extracts in food, but data to support its safe use have been lacking, according to the government. Literature reports raise safety concerns about the use of these forms of the plant. There are concerns about effects of whole … [Read more...]

Senators Follow up on Unanswered Antibiotic Resistance Questions

United States Senators Elizabeth Warren (D-MA), Dianne Feinstein (D-CA), and Kirsten Gillibrand (D-NY) sent a letter to the Interagency Task Force for Combating Antibiotic-Resistant Bacteria, asking again for information on how that body plans to address critical gaps in the FDA policies on overuse of antibiotics in food animals. A letter was sent in December 2014, but they have not received a formal response. The letter states, "we are extremely disappointed that we have not received a formal response form your office. Antibiotic-resistant bacteria present a major public health threat and public health experts agree that antibiotic resistance stems not only from antibiotic use in human medicine, but also from use in animals." The senators asked for a response within 30 days. They … [Read more...]

Report Finds Trans Fats Increase Mortality Risk

A study published in the BMJ (British Medical Journal) has found that consumption of trans fats is associated with greater risk of mortality, a greater risk of dying from heart disease, and a greater risk of developing heart disease. Researchers in Canada reviewed 41 observational studies, which means the association cannot be "causal". But the certainty between trans fat consumption and coronary heart disease is "moderate", and the certainty between saturated fat and all mortality outcomes is "very low". Dietary guidelines recommend that saturated fats should be limited to less than 10% of daily calorie intake. The report concludes that "Saturated fats are not associated with all cause mortality, CVD, CHD (coronary heart disease), ischemic stroke, or type 2 diabetes, but the … [Read more...]

FDA Releases NARMS Report on Antibiotic Resistance

The Food and Drug Administration (FDA) has released its 2012-2013 National Antimicrobial Resistance Monitoring System (NARMS) Integrated Report. The report focuses on major food born pathogens that are resistant to antibiotics important in human medicine, and on multidrug resistant pathogens. NARMS screens for non-typhoidal Salmonella, Campylobacter, E. coli, and Enterococcus. Salmonella and Campylobacter are the leading causes of bacterial food poisoning. The report reveals "mostly encouraging findings, with some areas of concern." About 80% of human Salmonella isolates are not resistant to any of the tested antibiotics. This number has not changed in the past 10 years. In addition, Salmonella multi-drug resistance has not changed, and the number of multi-drug resistant Salmonella … [Read more...]

FDA Orders Manufacturers to Omit Trans Fats Within 3 Years

Today, the FDA finalized its determination that trans fats, made from partially hydrogenated oils (PHOs), are not "generally recognized as safe" or GRAS, for use in human food. Food manufacturers will have three years to remove this ingredient from products. FDA's Acting Commissioner Stephen Ostroff said in a statement, "the FDA's action on this major source of artificial trans fats demonstrates the agency's commitment to the heart health of all Americans. This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year." Since 2006, food manufacturers have been required to include trans fat content information on nutrition labels on all food products. But manufacturers could put "0 grams trans fat" on the label if the product contained … [Read more...]

Details of 2008 Inspection Report at Jeni’s Ice Cream Facility

The FDA has released two inspection reports on Jeni's Ice Cream facility in Missouri. A 2008 report found problems, as did a 2015 report. The Missouri Department of Agriculture found Listeria monocytogenes bacteria in Jeni's ice cream in April 2015, and the plant shut down to find the problem. The 2008 report found that plant managers did not take measures to exclude pests from the processing areas. Rodent pellets were found along the oven wall, in the dry food product storage area, and throughout the storage area. A live rodent on a glue trap was found next to the cleaning supply door. The plant did not have adequate screening or other protection against pests. There were "numerous holes in the exterior wall of the facility without screening to prevent pest access." Garage bay doors … [Read more...]

Memorial Day and Summer Holiday Food Safety Tips from the FDA

The FDA has released tips on eating safely this Memorial Day. Safe food handling when eating outdoors is important and can be tricky. When you are transporting food for a picnic or potluck, make sure to keep cold food cold and hot food hot. Cold food should be stored at temperatures below 40°F to prevent bacterial growth. You can pack meat, poultry, and seafood while still frozen so they stay colder longer. Organize cooler components. A plain picnic basket usually isn't insulated enough to hold perishable foods. Use two coolers, with beverages in one and perishable foods in another. As people take out drinks, they won't expose food to warm outdoor temperatures. Keep coolers closed too. Keep raw meat, poultry, and seafood wrapped and separate from foods that will be eaten raw. … [Read more...]

FDA Report on Blue Bell Broken Arrow, OK Ice Cream Plant

The Listeria monocytogenes outbreak linked to Blue Bell ice cream has sickened 10 people and killed three of those patients. The FDA has issued a report on each of Blue Bell's facilities after extensive inspections and investigations. We told you about the Brenham, Texas facility inspection report last week. Now here are details on the Broken Arrow, Oklahoma facility. The initial recall of Blue Bell ice cream was for product made at the Brenham facility. But officials in Kansas conducted an investigation at the Via Christi hospital kitchen after a Listeria outbreak there earlier this year. An unopened single serving cup of Blue Bell ice cream taken from the hospital kitchen contained the pathogenic bacteria. That ice cream was made in the Broken Arrow plant. The inspection report … [Read more...]

Attorney Discusses Blue Bell FDA Inspection Reports

Attorney Brendan Flaherty, who is representing people sickened in the Blue Bell ice cream Listeria outbreak, discusses the FDA inspection reports about the company's facility. Since ice cream is a ready-to-eat food with no consumer "kill step" of cooking, any finding of Listeria in the plant is a serious issue. Listeria bacteria was present in the Broken Arrow, Oklahoma Blue Bell processing plant as early as March 2013, according to the report. Blue Bell was notified of its "improper cleaning" and continued to ship product from the facility. The company knew they had a "pervasive Listeria infestation in their plant. In the Broken Arrow, Oklahoma plant, they sanitized using normal procedures, and subsequent tests found more Listeria. In other words, the cleaning processes were not … [Read more...]

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