April 21, 2018

FDA Warns Companies That Make Coco Loko and Legal Lean as Unapproved New Drugs

The FDA is warning makers and manufacturers of two products, Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs. These products are promoted as alternatives to street drugs. The government has sent a warning letter to one company about this problem. Claims made in the promotional materials for the products demonstrate they are intended to be used as alternatives to street drugs. These products, as labeled and marketed, "may pose safety concerns," according to the press release. The FDA is concerned that these products encourage drug abuse in individuals, including minors. These street drug alternatives are used for recreational purposes to affect psychological states. FDA Commissioner Scott Gottlieb said … [Read more...]

FDA Warns Consumers About Adverse Events Associated with Limbrel, a Dietary Supplement

The FDA is alerting consumers about "potentially life-threatening health problems" linked to Limbrel, a dietary supplement that is marketed to "manage the metabolic processes associated with osteoarthritis." The company is not removing the product from the market. This product is marketed as a medical food, but the FDA's investigation determined that it is an unapproved new drug. And the FDA does not have mandatory recall authority over drug products. The FDA is reminding consumers "not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise … [Read more...]

Maker of Ruth’s Salads Warned About Listeria Monocytogenes Contamination by FDA

B&H Foods, the maker of Ruth's Salad, was warned about Listeria monocytogenes contamination in their facility by the FDA in November 2017. B&H Foods recalled Ruth's Pimento Spreads in February of this year for possible Listeria monocytogenes contamination, and expanded that recall later. No illnesses have been reported in connection with the consumption of these products. The warning letter is long and details many violations of the current Good Manufacturing Practice regulations for foods. First, during an FDA inspection in May 2017, environmental swabs were taken. Lab analysis found they contained Listeria monocytogenes bacteria, which made the products prepared in that facility adulterated. Two strains of Listeria bacteria were found. One was found in the Chester, … [Read more...]

FDA Alerts Public to Possible Mold in Comforts For Baby Purified Water

The FDA is alerting the public to a recall of Comforts FOR BABY Purified Water with Fluoride, sold in Kroger stores, for potential mold contamination. The product was recalled after consumers complained about seeing mold. Testing by Kroger identified the mold ad Talaromyces penicillium. The water is sold in clear 1 gallon containers, but the mold may not be visible to the eye. The product has sell by dates from 4/26/2018 to 10/10/2018. The UPC number on the product is 0 41260 37597 2 and the plant code is 51-4140. The labels also states DISTRIBUTED BY THE KROGER CO, CINCINNATI, OHIO 45202. The FDA is issuing this alert to reach parents and caregivers who may have bought the product and don't know about the recall. This product is intended for infants. It was sold to Kroger chain … [Read more...]

FDA Warns Against Harmful Effects of Kratom

The FDA is warning consumers about the risks of consuming kratom, which is an ingredient in dietary supplements that is sold as a treatment for depression, pain, and anxiety. First, those conditions are serious medical issues that should be diagnosed and managed by a licensed healthcare provider. And second, this substance can be addictive and has been linked to deaths.   Kratom is a plant that grows in Thailand, Malaysia, Indonesia, and Papua New Guinea. Supporters say that it's natural because it's a natural product. But it has effects similar to opioids, such as codeine and morphine, and can lead to abuse, addiction, and death. Kratom is often taken recreationally by users for euphoric effects. There is an opioid epidemic in this country, and officials say that the … [Read more...]

FDA Complaint Filed Against Michel Cordon Bleu for Adulterated Seafood

The United States filed a civil complaint against Michel Cordon Bleu Inc. of Los Angeles, California to prevent the distribution of adulterated seafood products on Tuesday, October 3, 2017. This complaint was filed in the US. District Court for the Central District of California. The Court was asked for a permanent injunction to shut down the facility which is located at 3625 South Western Avenue in Los Angeles. That company prepares, processed, packs, holds, and distributes vacuum-packed, ready-to-eat cold and hot smoked fish and fishery products. The complaint alleges that Michel Cordon Bleu and Michel G. Blanchet adulterated seafood products by "preparing, packing, or holding them under insanitary conditions whereby the seafood may have become contaminated with filth or may … [Read more...]

Why is a Product Recalled?

We tell you about food recalls every day. All foods in this country are regulated by the FDA and the USDA. Manufacturers must follow guidelines for production, label the food correctly, and make sure it won't make people sick. But when a problem occurs, a recall may be issued. And if a recalled product is an ingredient in other products, secondary recalls are issued. When a product is defective or harmful, removing it from the marketplace is the most effective way to protect consumers. Recalls are almost always voluntary. A company could discover a problem and recall a product on their own, or they could recall it after the FDA raises concerns. The FDA can also request a recall. The government oversees the recall strategy and assesses its adequacy. Food products may be recalled … [Read more...]

The FDA Weighs In on The Deadly Papaya Salmonella Outbreak

The FDA has updated its information on the deadly Salmonella outbreak linked to imported Maradol papayas. Increased testing by the FDA has found papayas from two farms positive for Salmonella strains that matched illnesses not related to the initial outbreak. So the FDA is telling consumers not to eat Maradol papayas from these farms in Mexico: Carica de Campeche in Tenabo, Campeche, Mexico; Caraveo Produce in Tecomán, Colima, Mexico; and El Zapotanito in La Huerta, Jalisco, Mexico. No papayas are currently on the market from these farms because their shelf life has passed, but the agency is continuing traceback and trace forward activities. Other importers may have sourced papayas from those farms. Three brand of Maradol papayas have been recalled:  Caribeña brand, distributed … [Read more...]

The Smokehouse of NY Closed By Permanent Injunction

The Smokehouse of NY, LLC entered a consent decree of permanent injunction on June 29, 2017, after a federal judge ordered them to stop selling their products until it can comply with food safety regulations. According to the FDA, the facility was contaminated with Listeria monocytogenes bacteria. Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs said in a statement, "The Smokehouse of NY had several opportunities to come into compliance with the law. Through the use of modern technology, the FDA was able to establish that the company has resident strains of L. mono in its facility that it has consistently failed to eradicate. Conditions like these are unacceptable and the FDA took action to protect Americans." The complaint listed a long history of recurring … [Read more...]

Food Safety for Older Adults

The FDA has released information about food safety for older adults. Anyone who is over the age of 65 needs to be very vigilant about food safety. Many of those who become seriously ill and even die from food poisoning are elderly. The bodies of older adults do not work as well as they did decades ago. The stomach and intestinal tract hold onto food for longer periods of time, the senses of smell and taste are altered, and the liver and kidney's don't work as well to get rid of toxins. And by the age of 65, many people have been diagnosed with a serious illness. That is a double whammy, since people with chronic health problems are also at higher risk for serious complications from food poisoning. After the age of 75, many people also have reduced immune system responses. That … [Read more...]

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