October 30, 2020

FDA Investigates Two E. coli Outbreaks That May Be Romaine

The FDA is investigating two E. coli outbreaks that may be caused by romaine lettuce. Those outbreaks were announced by the Centers for Disease Control and Prevention (CDC) on Wednesday, October 27, 2020. Both of these outbreaks are caused by E. coli strains that are genetically related to two previous romaine outbreaks: One in in 2019 from Salinas, California lettuce. and one in 2018 from Yuma, Arizona lettuce. FDA Deputy Commissioner for Food Policy and Response said in a statement, "The FDA, along with the CDC and our state and local partners, are working to investigate two outbreaks of Shiga toxin-producing E. coli O157:H7 (STEC) illnesses. We do not know what food is causing people to get sick or whether it involves an FDA-regulated food product. However, we have seen similar … [Read more...]

OxyElite Pro Dietary Supplement Executives Sentenced in Fraud Scheme

A federal court in Texas has sentenced two former OxyElite Pro dietary supplement executives to prison and ordered two companies to pay $10.7 million in criminal forfeiture for fraudulently selfing popular workout supplements called Jack3d and OxyElite Pro, according to the United States Department of Justice. U.S. District Judge Sam A. Lindsay presided. Former USPlabs CEO Jacobo Geissler was sentenced to 60 months, and former USPLabs president Jonathan Doyle was sentenced to 24 months. All of the defendants were charged in a 2015 indictment returned by a federal grand jury in the Northern District of Texas. U.S. Attorney for the Northern District of Texas, Erin Nealy Cox, said in a statement, "Dietary supplement companies cannot be allowed to deceive their consumers and hide the … [Read more...]

FDA Warning Letter to Dole Fresh Vegetables Mislabeled Tuscan Herb Salad

The FDA has sent a warning letter dated September 25, 2020 to Dole Fresh Vegetables at 2959 Salinas Highway in Monterey, California, after failure to comply with preventive controls of thee Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.  The product, HEB Tuscan Herb Chopped Salad Kit, was recalled in March 2020 for undeclared peanuts, wheat, soy, and tree nuts, four of the major food allergens. The FDA states that the company said that the mislabeling occurred when the incorrect masterpack kit, which is the kit containing the dressing and other toppings, was "unintentionally used during the production of the salad." The company also stated that the firm "did not have a robust enough verification process for product … [Read more...]

Texas Court Sentenced Blue Bell Creameries; Will Pay $17.25 Million in 2015 Listeria Outbreak

A federal court in Texas has sentenced Blue Bell Creameries  to pay $17.5 million in criminal penalties in association with the deadly 2015 Listeria monocytogenes outbreak that killed three people who lived in Kansas. The company allegedly shipped contaminated product to hospitals where patients who were already susceptible to infection ate the ice cream in milkshakes and ice cream cups. In May 2020, Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream products. The $17.25 million fine and forfeiture is the largest ever criminal penalty in a food safety case. Judy McMeekin, Pharm.D., Associated Commissioner for Regulatory Affairs in the FDA, said in a statement, "The health of American consumers and the safety of our food are too important to … [Read more...]

FDA Issues the First Injunction Under the Produce Safety Rule

The FDA has issued its first injunction under the Produce Safety Rule against a company that makes sprouts and soy products. That Rule, which was part of the Food Safety Modernization Act of 2011 and was finalized on January 26, 2016, gives the FDA power to issue consent decrees of permanent injunction against corporations for violating safety standards. The Produce Safety Rules mandates that sprout operations take measures "to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions … [Read more...]

Don’t Use Maison Terre Goldenseal Root Powder, FDA Says

The FDA is telling health care professionals and consumers to not use a product called Maison Terre Goldenseal Root Powder, because it is contaminated with high counts of various bacteria, including "multiple pathogens," according to a government press release. The company that repackaged and distributed this product, Maison Terre, is located in Little Rock, Arkansas. Goldenseal root powder has been used in various ways as a herbal supplement. It can be made into a tea, or ingested if sold in tablet or capsule form. It also may be applied to the skin as a topical treatment. Some people use it for indigestion and heartburn, and it has been used as a mouthwash to help heal canker sores. FDA laboratory analysis discovered the contamination. The advisory states, "Use of these … [Read more...]

FDA Recalls Certain Hand Sanitizers with 1-Propanol as Toxic

The FDA is recalling certain hand sanitizers with 1-propanol as toxic, adding to the  list of hand sanitizers that contain methanol, or wood alcohol. These hand sanitizers are labeled to contain ethanol or isopropyl alcohol, which are the correct ingredients, but have tested positive for 1-propanol contamination, which is not an acceptable ingredient for hand sanitizer. Scroll down in the linked document to find the long list of recalled hand sanitizers. Ingesting 1-propanol can cause central nervous system depression, which can result in death. Symptoms of 1-propanol exposure include confusion, decreased consciousness, and slowed pulse and breathing. Animal studies have shown that the central nervous system depressant effects of 1-propanol are two to four times as potent as … [Read more...]

FDA Announces Voluntary Phase Out of PFAS Used in Food Packaging

The FDA is announcing a voluntary phase out of PFAs that are used in some types of food packaging. PFAS are short chain per- and poly-fluoroalkyl substances that contain 6:2 fluorotelomer alcohol. This is often used as grease-proofing agents on paper and paper board food packaging. Food safety experts are concerned that the use of these compounds in food packaging. Since paper and paperboard come into contact with food, experts think the chemicals may migrate into the food. PFAS are very persistent, which means they don't break down and can accumulate over time. In animals, PFAS have caused reproductive, developmental, liver and kidney, and immunological effects. They have also caused tumors in animals. In human studies, PFAS can cause increased cholesterol levels, and more … [Read more...]

FDA Puts Some Hand Sanitizer Manufacturers on Import Alert

The FDA is reiterating its warning about dangerous alcohol-based hand sanitizers that contain undeclared methanol, and is also putting some hand sanitizer manufacturers on import alert. That means that any product those companies try to import into the United States will be stopped and held at the border. The government is also working with these hand sanitizer manufacturers to recall products and is encouraging retailers to remove recalled products from store shelves. The FDA first became aware of this problem in June 2020 and issued warnings to consumers at that time. Another warning was issued earlier this month about "an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily … [Read more...]

FDA Expands Recalls of Hand Sanitizers That Contain Methanol

The FDA has expanded recalls of some brands of hand sanitizers that may contain methanol, or wood alcohol, that is toxic and can be absorbed through the skin. The sanitizers are labeled as made with ethyl alcohol, but contain methanol. Methanol can be life-threatening if ingested. Children may accidentally drink it, and some adults use it as a substitute for alcohol. The FDA knows of some cases of children and adults suffering blindness, who were hospitalized, and who died after drinking hand sanitizers. Symptoms of substantial methanol exposure can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Properly made hand sanitizers are a substitute for hand-washing, but they must contain at least 60% … [Read more...]

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