June 21, 2018

Precut Melon Linked to Salmonella Outbreak Sold in More States: AL, CA, FL, KS, MD, MN, NE, ND, SD, and TN; Lawsuits Filed

The FDA just stated that there are more states where precut melon and fresh-cut melon products linked to a Salmonella Adelaide outbreak were sold. They were also sold in Alabama, California, Florida, Kansas, Maryland, Minnesota, Nebraska, North Dakota, South Dakota, and Tennessee. That means the states that received these products include Alabama, California, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Nebraska, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Virginia, West Virginia, and Wisconsin. The products were packaged in clear plastic clamshell containers and were sold under several different brand names. The stores that the FDA has listed as carrying the melons are Costco, Jay C, Kroger, … [Read more...]

FDA Seeks Injunction Against Company Selling Unapproved Hand Sanitizers

One part of food safety is keeping your hands clean. That's why food safety experts tell consumers to wash their hands before they prepare food or before they eat. That can be difficult when you are away from home. That's why hand sanitizers are so popular. But one company is selling unapproved hand sanitizers that claim to prevent infections from many different pathogens, so the FDA is seeking a permanent injunction against that company. The company is BioDefense Inc. of Lake Forest, California. The product is Zylast topical antiseptics. The company claims that the hand sanitizer is effective against pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. These are drug claims, and so the product is regulated by FDA as a … [Read more...]

FDA Warns Companies to Stop Selling Highly Concentrated Caffeine Products

The FDA is warning companies that make two highly concentrated caffeine products to stop making them, because the government considers them a threat to public health. The companies are Liquidcaffeine and Dual Health Body and Mind. FDA Commissioner Scott Gottlieb said, "Despite being informed of the dangers of highly concentrated and pure caffeine, we’re still finding companies that are disregarding consumer safety by illegally selling products with potentially dangerous and lethal amounts of caffeine. The FDA recently took action to explain which pure and highly concentrated caffeine products cannot be lawfully marketed because they pose an unacceptable risk to consumers. We’ve already seen at least two deaths linked to pure or concentrated caffeine, and we’ll be enforcing the law to … [Read more...]

FDA Sends Warning Letter to Maker of Necco Wafers and Sweethearts

The FDA has sent a warning letter to the maker of Necco Wafers and Sweethearts about the conditions in their facility. The letter was sent to the New England Confectionary Company in Massachusetts. The inspection conducted late last year found "serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation." The violations included "significant evidence of rodent activity and insanitary conditions" throughout the facility. That means the candy products are adulterated. FDA inspectors found evidence of rodent activity in the food storage areas of the facility. Rodent excreta pellets that were too numerous to count and evidence of widespread rodent activity were found in "multiple areas" throughout the … [Read more...]

FDA Takes Action Against OTC Teething Products That Contain Benzocaine

The FDA is warning consumers that over-the-counter (OTC) teething products that contain Benzocaine pose "a serious risk to infants and children." The agency announced that those products containing that pain reliever should no longer be marketed, and is asking companies to stop selling these products. If the companies do not comply, the FDA will initiate a regulatory action to remove those products from the market. The FDA is also asking that companies add warnings to all other benzocaine oral health products to describe some serious health risks. FDA Commissioner Scott Gottlieb said, "The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit. Because of the lack of efficacy for teething and the … [Read more...]

Food Safety and Consumer Groups Want FDA To Establish Rapid Traceability Of Produce

Food safety groups and consumer groups are calling on the FDA to establish requirements for rapid traceability of produce within the next six months. Nine organizations sent a letter to the FDA on May 24, 2018, after government officials have not solved the deadly multistate E. coli O157:H7 HUS outbreak linked to romaine lettuce. The groups that signed the letter include Center for Science in the Public Interest, Consumer Federation of America, Food and Water Watch, STOP Foodborne illness, Consumers Union, The Pew Charitable Trusts, and three others. They want the FDA to implement "long overdue provisions of the 2011 FDA Food Safety and Modernization Act (FSMA)" that require the FDA to establish record keeping requirements for high risk foods that will enhance … [Read more...]

FDA Sends Warning Letter To Three Companies Selling Unapproved Kratom Products

The FDA is warning companies that sell illegal, unapproved kratom products marketed for opioid cessation, pain treatment, and other medical uses to stop. Three corporations were issued warning letters on May 22, 2018: Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California, and Revibe, Inc., of Kansas City, Missouri. The government states that those companies are illegally selling unapproved kratom-containing drug products and making unproven claims about their ability to help in the treatment of opioid addition and withdrawal. Other unproven claims the FDA alleges the companies are making including treating pain, lowering blood pressure, treating cancer, and reducing neuron damage caused by strokes. The FDA has repeatedly warned consumers that no kratom product … [Read more...]

FDA and Lawyer Explain Why Deadly Romaine E. coli O157:H7 HUS Outbreak Is Unsolved

The FDA has issued a report on the deadly E. coli O157:H7 HUS outbreak that is linked to romaine lettuce. A least 172 people in 32 states are sick in this outbreak. One person in California has died, 75 people have been hospitalized, and 20 have developed hemolytic uremic syndrome. While FDA officials have identified Harrison Farms of Yuma, Arizona as the grower and sole source of the whole-head romaine that sickened eight in the Anvil Mountain Correctional Facility in Nome Alaska, they do not know where in the supply chain the contamination occurred. It could have been in the fields, during harvest, during processing, or during transport. The issue in this outbreak is that the romaine lettuce that would have made people sick wasn't available at exposure locations when ill people … [Read more...]

Trends in Food Recalls Finds Recalls Increased Significantly Between 2004 and 2013

The USDA and FDA have issued a report on food recall trends from 2004 to 2013. In it, they find that recalls increased significantly in that time period. The report, titled "Trends in Food Recalls: 2004-2013" was published in April 2018. Between 2004 and 2008, food recalls in the United States averaged 304 a year. Between 2009 and 2013, the annual average increased to 676 recalls. The volume of food sold in the United States during the latter time period partially explains the statistically significant increase, but other factors are involved too. During the 2009 to 2013 time frame, pathogen and risk detection technology improved substantially. In addition, regulatory oversight and enforcement increased. Finally, Congress passed the Food Safety Modernization Act and the Food … [Read more...]

FDA Recalls and Destroys Kratom Products; Kratom is Associated with a Multistate Salmonella Outbreak

The FDA has said it has recalled and destroyed products made with kratom, and warns consumers that the substance can be hazardous. The supplements it has collected and destroyed were distributed nationwide under the brand names Botany Bay, Enhance Your Life, and Divinity by Divinity Products Distribution of Grain Valley, Missouri. The company has agreed to stop selling all products containing kratom.   The FDA is also encouraging all companies that sell products containing kratom to take steps to remove their products from the market and submit evidence to the FDA to evaluate them according to the regulatory pathway. Government officials are concerned about this product since the FDA has stated that 36 deaths are related to the use of the product. In addition, kratom products … [Read more...]

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