January 20, 2018

FDA Responds to OIG Report Criticizing Recall Response

The FDA has responded to an Office of the Inspector General (OIG) report stating that the agency is slow to respond to critical food recalls. The final version of the report looked at recall practices from October 1, 2012 to May 4, 2015. FDA Commissioner Scott Gottlieb said, "Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission." The FDA response stated that the most efficient way to ensure unsafe foods are quickly recalled is to work directly with the companies and giving the public information about the recall. The FDA is going to issue guidance on recall communications in … [Read more...]

FDA’s Recall Process Did Not Always Ensure Nation’s Food Supply Safety

The FDA's recall process did not always ensure the safety's of this country's food supply, according to a report released today by the Office of Inspector General (OIG) of U.S. Department of Health and Human Services. Reviews of the recall process oversight were conducted previously. According to the repot, "At the time of those OIG reviews, FDA did not have statutory authority to require food manufacturers to initiate recalls of most foods.." Enactment of the Food Safety Modernization Act (FSMA) in 2011 gave the FDA new authority to order a mandatory recall to force firms to recall potentially harmful foods. The review of the OIG was conducted to determine whether or not the FDA is fulfilling its responsibility to safeguard America's food supply. The objectives of the report … [Read more...]

FDA Proposes New Enforcement to Protect Consumers from Unproven Homeopathic Drugs

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that may be harmful. FDA is going to update its existing policy to address situations where these treatments are marketed for serious diseases and conditions, but have not shown any clinical benefits. The policy will also cover situations where these products contain potentially harmful ingredients or don't meet current good manufacturing practices. FDA Commissioner Dr. Scott Gottlieb said in a statement, "In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in … [Read more...]

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...]

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