April 13, 2021

FDA Updates Real Water Non-viral Hepatitis Outbreak

The FDA has updated the Real Water non-Viral hepatitis outbreak that has sickened at least five children living in Nevada. The consumption of Real Water brand alkaline water is the only common link identified among all of the cases so far. This brand of water is owned by Real Water, Inc. of Mesa, Arizona. FDA is in the beginning stage of this investigation, and more products may be connected to this outbreak. An investigation at the Real Water firm has begun. What's new in this update s that the government has added areas in the country where the water was distributed. The water was sold in 5-gallon containers through home delivery and subscription; in bottles that were sold online and in stores; and as "Real Water" concentrate that is sold online. The 5-gallon containers are … [Read more...]

FDA Warns Earth Tea Against False Statements About COVID-19

The FDA has sent a warning letter to B4B Corporation, makers of Earth Tea, against false statements regarding the treatment and cure of COVID-19. The FDA says that the company is offering the product for sale and that it is intended to "mitigate, prevent, treat, diagnose, or cure COVID-19 in people." That makes the product and unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act and also makes the product a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. Some examples of claims on the company's website that misleading represent the product as safe and/or effective for the treatment and prevention of the viral illness include, "Earth Tea works fast so it can eliminate quarantine time. With those simple steps we can move to end the … [Read more...]

FDA Warns Mercola Over Products Claiming to Treat and Cure COVID-19

The FDA has sent a warning letter to Mercola.com about their products being marketed as diagnostic tools, treatment options, and cures for COVID-19. The letter, dated February 18, 2021, addresses "Unapproved and Misbranded Products Related to Coronavirus Disease 2019." The company's websites and social media accounts promote these products which are considered unapproved new drugs sold in violation of the FDA's Food, Drug and Cosmetic Act. The FDA is taking urgent measures to protect consumers that, without approval or authorization by that agency, claim to "mitigate, prevent, treat, diagnose, or cure COVID-19 in people." The government states that Mercola must take immediate action to cease the sale of these unapproved and unauthorized products. Some of the claims on the … [Read more...]

Real Water Non-Viral Hepatitis Illnesses Investigated by FDA

The FDA is investigating Real Water non-viral hepatitis illnesses, according to an outbreak investigation notice. The CDC and the Southern Nevada Health District are aiding in the investigation. On March 13, the FDA was told by the Southern Nevada Health District about five cases of acute non-viral hepatitis in infants and children that occurred in November 2020 with an unknown cause. Those cases resulted in acute liver failure. All five patients were hospitalized and have since recovered. All of these children live in Nevada. The last illness onset date was November 29, 2020. All of the children consumed "Real Water" brand alkaline water. The patients lived in four different households. Five more people, including two adults and three children, from two of the four households … [Read more...]

Arby’s Norovirus Outbreak in Springfield, Illinois Sickens 92

An Arby's norovirus outbreak in Springfield, Illinois has sickened at least 92 people and the restaurant has closed for a second time in less than a month. That restaurant is located at 3009 South Dirksen Parkway in Springfield. Sangamon County public health officials confirmed to News Channel 20 that norovirus is the cause of the illnesses. Norovirus is an extremely contagious virus that causes symptoms of diarrhea, nausea, and vomiting. Illness onset is quick, usually within a couple of hours, and the illness resolves quickly, often with a day or two, with patients typically not needing medical attention. The illness is spread person-to-person, through contact with contaminated surfaces, and through contaminated food and drink. The restaurant closed in late February after about … [Read more...]

Another Mystery E. coli O157:H7 Outbreak Ends With 22 Sick

Another mystery E. coli O157:H7 outbreak has ended with no source, according to the Centers for Disease Control and Prevention (CDC)> The FDA and USDA collected different types of dates but were unable to identify a food source of this multistate outbreak. The outbreak is over as of March 11, 2021. Last summer and fall, the CDC announced two other mystery E. coli O157:H7 outbreaks that sickened a total of 44 people, hospitalizing 18. The pathogen in one of those outbreaks was linked to bacteria that sickened people in a 2019 romaine lettuce outbreak. A total of 22 people in 7 states were sickened in this latest outbreak.  The case count by state is: Arkansas (9), Maryland (1), New York (1), Oklahoma (6), Texas (1), Virginia (2), and Washington (2). Illness onset dates ranged … [Read more...]

Three Outbreaks on the FDA CORE Investigation Table; Two Are Unsolved

There are currently three outbreaks on the FDA CORE Investigation Table and two remain unsolved. The first is caused by Salmonella Miami, with 64 sickened and no product or place identified. The second is an E. coli O157:H7 outbreak that has sickened 16 people, with no product or place identified. And the third is the Listeria monocytogenes outbreak that has sickened 11 people, linked to recalled El Abuelito queso fresco cheese. The number of identified outbreaks continues to be slow. During the pandemic last year, the number of outbreaks was at a real low, with only ten multistate food poisoning outbreaks identified in the entire year. Two of the outbreaks have CDC investigation notices. The E. coli O157:H7 outbreak has not been updated since February 2, 2021, but officials seem … [Read more...]

El Abuelito Cheeses Were More Widely Distributed Than First Thought

UPDATE 3/9/21: El Abuelito cheeses were also sold in Rhode Island. The FDA has updated its investigation into the deadly multistate Listeria monocytogenes outbreak that is linked to recalled El Abuelito queso fresco and has revealed that El Abuelito cheeses were more widely distributed than first thought. The case count still stands at 11 sick, with 10 hospitalized and one death. Four patients were from Maryland and four from New York, with one from Connecticut and two from Virginia. The recalls are also unchanged. The first recall, issued on February 19, 2021, after whole genome sequencing testing conducted by the state of Connecticut found the outbreak strain in a sample of El Abuelito queso fresco, was for El Abuelito Queso Fresco as well as the brands Rio Grande and Rio Lindo … [Read more...]

Permanent Injunction Issued Against Dietary Supplement Confidence USA

An order of permanent injunction has been entered against Confidence USA Inc. of Long Island, New York, and the company's president Helen Chian and general manager and founder Jim Chao by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York. The order was entered until the company "comes into compliance with federal supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements." The defendants must cease manufacturing, holding, or distributing dietary supplements until the FDA tells them they can resume operations. The company has made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. … [Read more...]

Michigan National Guard Sickened After Being Served Undercooked Food

About 50 members of the Michigan National Guard have been sickened with what may be food poisoning after they were allegedly served undercooked chicken and food that is "raw and moldy" while deployed in Washington, D.C. Some were sent to the hospital. Some troops were  hospitalized, according to a letter from the state's House delegation that was sent to CBS News, although the National Guard denies that. The troops were served food by private contractors hired by the National Guard Bureau. Pictures of undercooked chicken have been circulating on social media. An unidentified sergeant told WXYZ.com that "there were 74 meals found with raw beef in them. Just yesterday, the lunches were, soldiers had found metal shavings in their food." Senator Gary Peters (D-MI) has asked that the … [Read more...]

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