August 28, 2016

FDA Warns Aspirin-Containing Antacids Can Cause Bleeding

The FDA is warning consumers that over the counter heartburn or antacid medications that contain aspirin can cause stomach or intestinal bleeding. While cases of bleeding are rare, in 2009 the FDA issued a warning about this risk associated with consuming aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). The FDA has discovered eight new cases of serious bleeding caused by aspirin-containing antacids since the first warning in 2009. Some of those people were so sick they needed a blood transfusion. Dr. Karen Murry Mahoney, Deputy Director of the Division of Nonprescription Drug Products at FDA said, "take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach problems. Unless people read the Drug … [Read more...]

Consent Decree Shuts Down Kwong Tung Foods

The U.S. District Court for the District of Minnesota has entered a consent decree of permanent injunction against Kwong Tung Foods Inc., doing business as Canton Foods to prevent the distribution of adulterated noodles and sprouts. The complaint was filed on July 14, 2016 at the request of the FDA. The complaint alleges that Kwong Tung Foods violated the federal Food, Drug, and Cosmetic Act by preparing, packing, and/or holding noodles and sprouts under insanitary conditions so the food may have been contaminated with filth or rendered injurious to health. The facility, according to the complaint, failed to exclude pests and rodents, failed to maintain equipment, and failed to ensure adequate employee sanitation. Principal Deputy Assistant Attorney General Benjamin C. Mizer, … [Read more...]

FDA Warning Letter Sent to Lavella Brothers Warehouse

On June 23, 2016, the FDA sent a warning letter to Lavella Brothers food warehouse in Chester, Pennsylvania after an inspection on May 4 through May 26, 2016 found "significant violations of the FDA's Current Good Manufacturing Practice (cGMP) regulations. The violations "cause the food products stored at your facility to be adulterated, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contamianted with filth or rendered injurious to health." The facility is also not registered with FDA. The violations included: not using water that is safe and of adequate sanitary quality in food and food-contact surfaces. The firm did not have running water in the restrooms, and the toilets and hand washing sinks were not functioning. There had … [Read more...]

FDA to Tighten Labels and Marketing of Animal Antibiotics

Recently, an antibiotic-resistant superbug called MCR-1 has been found in two people and two pigs in the United States, and it was just found in the water in Rio de Janeiro. Brazilian scientists discovered a drug-resistant bacteria off the coast of one of the city's beaches, one month before the Summer Olympics starts. Giving antibiotics to food animals at sub-therapeutic doses is one way that these superbugs evolve. The MCR-1 resistance gene makes the last-line antibiotic colistin useless. The gene has been found in other bacteria in other countries. Since this gene can be transferred to other organisms, scientists are very worried. So the FDA is planning to tighten labels and marketing options for antibiotics intended for animal use. That agency sent a letter to animal drug … [Read more...]

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...]

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