June 30, 2016

FDA Requests Data About Safety of Hand Sanitizers

The FDA issued a proposed rule yesterday requesting additional scientific data to support the safety and effectiveness of ingredients used in hand sanitizers that are marketed over the counter. The agency wants to make sure that regular use of these products doesn't present unknown safety and efficacy concerns. This does not mean the FDA thinks these products are unsafe or ineffective. Antiseptic rubs are products used when soap and water are not available. They are left on and not rinsed off with water. Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said in a statement, "today, consumers are using antiseptic rubs more frequently at home, work, school, and in other public settings where the risk of infection is relatively low. These products … [Read more...]

FDA Too Slow To Issue Recalls, HHS Audit Says

The FDA is too slow to get food companies to recall contamianted products, according to an audit by the Department of Health and Human Services (HHS). In some cases, firms waited for months before they recalled their products that caused many illnesses. The HHS Office released a report that states "we found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation's food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA's immediate attention." FDA relies on firms to recall food that can be harmful to the public health. The government did not have the authority to … [Read more...]

Don’t Eat Raw Dough for Food Safety Reasons

The FDA blog is focusing on raw dough today. The government is warning consumers that eating raw dough is risky and could give you food poisoning. While most people think that part of making cookies and cake is eating the raw dough or batter, you could get sick. Kids are especially vulnerable to serious complications from food poisoning, including kidney failure and death. The E. coli O121 outbreak linked to General Mills flour is a case in point. Flour is a raw agricultural product that can harbor pathogenic bacteria. Heat is the only thing that will kill those bacteria. A government investigation found that raw dough eaten or handled by some of those sickened was made with General Mills flour produced in their Kansas City, Missouri facility. Bacteria in a flour sample was linked to … [Read more...]

FDA Targets Internet Sales of Illegal Prescription Meds

The FDA, in partnership with international regulatory and law enforcement agencies, took action in June against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The effort, led by INTERPOL, was part of Operation Pangea IX. George Karavetsos, director of the FDA's Office of Criminal Investigations, said, "preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers' health. Operation Pangea IX demonstrates the FDA's continuing commitment to stand united with our international partners to protect consumers in the United States and throughout the world from criminals who put profit above the health and safety of consumers." The action ran from May 31 to June 7, 2016. Extensive … [Read more...]

Food Safety Issues Prompt FDA Warning Letter to Whole Foods North Atlantic Kitchen

Food safety violations at the Whole Foods North Atlantic Kitchen in Everett, Mass. are serious enough that food made there is considered adulterated, the U.S. Food and Drug Administration told the company in a warning letter dated June 8, 2016. Among the agency's finding at the facility was a positive tests for non-pathogenic Listeria on food contact surfaces.  The finding shows conditions inside the facility would support the presence and growth of Listeria monocytogenes, a pathogen, the agency said. Under the Food and Drug Act, foods are considered adulterated if they "were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health." In addition to finding non-pathogenic Listeria, the agency found: food was … [Read more...]

Before Listeria Outbreak, CRF Uncooperative with FDA, Documents Show

Updated June 15 Before being linked to a multistate Listeria outbreak that includes eight illnesses and two deaths, CRF Frozen Foods was reluctant to cooperate with inspectors from the U.S. Food and Drug Administration (FDA) and was advised of legal sanctions available to the agency if the firm did not correct serious deficiencies, documents released this week by the agency reveal. On April 23, CRF Frozen Foods issued a recall of 11 frozen vegetables for possible Listeria contamination. On May 2, 2016, CRF expanded the recall to include all organic and traditional frozen vegetable and fruit products processed in its Pasco, Washington facility since May 1, 2014. The expanded recall, includes 358 consumer products sold under 42 separate brands. On May 3, the company was linked to a … [Read more...]

Flour and Other Contaminated Foods: Food Defect Action Levels

The recall of Gold Medal flour for possible E. coli O121 contamination and the outbreak that is associated with those products reminded me of my food safety classes at the University of Minnesota. The CDC stated tonight that "collaborative investigative efforts indicate that flour produced at the General Mills facility in Kansas City, Missouri is a likely source of this outbreak." While E. coli bacteria in flour may seem unlikely to many, it does happen. And foods do contain "icky" ingredients in addition to bacteria. Most people don't know that there are allowable levels of "unavoidable defects" in food and that the FDA has set these levels to below what would make an average person ill. Those "defects" include the presence of insect filth, maggots, insect eggs, mold, grit, rust, and … [Read more...]

FDA Issues Final Food Defense Regulation

The FDA released the Food Safety Modernization Act (FSMA) final rule for mitigation strategies to protect food against intentional adulteration last week. This rule is intended to prevent public harm by requiring companies in the U.S. and abroad to take steps to prevent adulteration of the food supply. These facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination. They must also establish food defense monitoring procedures and corrective actions, verify that the system is working, and ensure that personnel assigned to these areas receive training and maintain records. Before 1982, most food and drug products did not have tamper-proof packaging or tamper-resistant seals. In 1982, seven … [Read more...]

FDA Releases Year 5 Reportable Food Registry

The Reportable Food Registry is released by the Food and Drug Administration every year. It is a synopsis of a one-year reporting period from the Registry. The current edition is the 5th Annual Report: September 8, 2009 through September 7, 2014. The FDA is required to establish an electronic portal. Reports about instances of reportable food must be submitted to the FDA within 24 hours. A reportable food is an article of food or feed for which there is reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to people or animals. The RFR is considered an early warning tool for public health risks and helps the government remove contaminated foods from the marketplace. The RFR covers all human and animal … [Read more...]

Issues Found at CRF Frozen Foods Linked to Listeria Outbreak

The FDA has released a 483 inspection report about the conditions at CRF Frozen Foods plant in Pasco, Washington. That report, released on May 12, 2016, gives more information about the conditions at that plant. Food produced at that facility has been linked to a Listeria monocytogenes outbreak that goes back to 2013, and has led to dozens of frozen produce recalls. At least eight people in three states have been sickened in this outbreak. Damaged equipment described as being "impossible to clean" could be a factor in this contamination. The inspection, conducted March 14 to March 17, 2016, may provide some insight into how the produce was contaminated. The company was told on April 25, 2016 that a Listeria monocytogenes outbreak going back to 2013 was linked to its products by whole … [Read more...]

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