September 28, 2016

FDA Issues Revised Draft Guidance to Improve Supplement Safety Notifications

The FDA issued a revised draft guidance on August 11, 2016 to improve dietary supplement companies' new dietary ingredient (NDI) premarket safety notifications to the government.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...]

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...]

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