April 22, 2018

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...]

Reishi D. Supplement Facility Warned by FDA

The FDA has sent a warning letter to the Reishi D. International dietary supplement facility in South San Francisco, California. Inspectors found serious violations of the current Good Manufacturing Practice, which means the product is considered adulterated. Inspectors also collected labels and brochures for the supplement that contain violations of the Act and regulations. The supplement is considered a drug because it is "ntended for use in the cure, mitigation, treatment, or prevention of disease." Claims on the product, such as "has been used in Traditional Chinese Medicine for thousands of years.." and "Propolis … contains more than 30 different flavonoids and antioxidants to help control free radicals. Free radicals are caused by waste from our body cells that increase with … … [Read more...]

FDA Publishes Risk Profile of Pathogens and Filth in Spices

Did you know that spices can contain pathogenic bacteria and filth? The FDA has published the 2017 Risk Profile of Pathogens and Filth in Spices to "describe the nature and extend of the pubic health risk posed by consumption of spices in the U.S." The report identifies the most commonly occurring microbial hazards in spices, and evaluates the current mitigation and control options. There have been recalls of these types of products for possible bacterial contamination in the past few years. In October 2017, for example, Spicely Organics recalled tarragon for possible Salmonella contamination. And in 2014, some Costco pepper was recalled, also for Salmonella. The draft risk profile did identify Salmonella as the pathogen most commonly associated with human illness that was … [Read more...]

FDA Releases Information About Opioid Compounds in Kratom

The FDA released information about adverse events and scientific analysis providing evidence of opioid properties in kratom, an ingredient used in some dietary supplements. Food Poisoning Bulletin told you about a warning the FDA issued last November about this ingredient, stating that the substance is addictive and has been linked to deaths in this country. The FDA conducted a scientific analysis using a computational model developed by scientists in the agency, which provides "even stronger evidence of kratom compounds' opioid properties." More adverse events involving this product have been reported. Government officials are concerned about the use of this substance to treat opioid withdrawal symptoms. The press release states that "there is no reliable evidence to support the … [Read more...]

Stericycle Posts Information on Food Recalls in 2017

Stericycle Expert Solutions keeps track of recalls issued by the FDA and USDA every quarter and every year. For the fourth quarter of 2017, they found that FDA food recalls declined 5% to 150 - the lowest number since the first quarter of 2016. And recalled FDA for units declined 93% to 7 MM, which is less than any quarter since the first quarter of 2016 and lower than 9 of the last 12 quarters. On the other hand, USDA recalls increased 17% to 28, which is still lower than four of the last five quarters. Recalled pounds of USDA-regulated foods dropped 92% to 597,896, which is the lowest since the third quarter of 2013. Most of the FDA recalls, or 54.7%, were for undeclared allergens in foods, which is up from 371% in the second quarter of 2017, and almost the same as the third … [Read more...]

Prescription Medical Food Limbrel Recalled for Serious Adverse Events

Primus ia voluntarily recalling all lots within a certain expiration date of Limbrel, a prescription medical food, because of rare but serious and reversible adverse events. There have been 30 adverse events reported to the government between January 7, 2007 and November 9, 2017. Elevated liver function tests or acute hypersensitivity pneumonitis have been associated with the use of Limbrel products. These conditions occurred in rare cases with varying degrees of severity in patients taking Limbrel for the first time within the first few weeks. Patients may not notice the adverse effects until they consult with their doctor or until they need to be hospitalized. No deaths have been reported, and all adverse effects resolved without any residual problems after the patient stopped taking … [Read more...]

What Happens to the FDA, CDC, and USDA During the Government Shutdown?

The United States government is under a shutdown as of January 20, 2018. What does that mean to the work done by the FDA and USDA to help keep our food supply safe? The FDA has posted a statement saying that "only some of our work is permitted to continue during a lapse in funding." Agency operations will continue in areas that address "imminent threats to the safety of human life and activities funded by carryover user fee funds." The FDFA will still monitor for and respond to food poisoning outbreaks; will support high-risk food and medical product recalls when those products endanger consumers; pursue criminal and some civil investigations when they believe the public health is at risk; screening food and medical products imported to the U.S.; and address "other critical pubic … [Read more...]

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...]

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