September 16, 2021

Active Food Poisoning Outbreak Investigations From FDA and USDA

What are the current active food poisoning outbreak investigations that the FDA and USDA are investigating? While there have been several outbreak investigations that have closed, there are still six open investigations on the FDA Outbreak Table, and one, possibly two, investigations on the USDA Table. On the FDA Table, there are two cyclospora outbreak investigations. Neither has any product linked to it. The first outbreak has 37 patients, an increase of two more patients since the last update 12 days ago. Traceback has been initiated, but there has been no on-site inspection, no sample collection, and no analysis. The second cyclospora outbreak has 119 patients, an increase of one patient since the last update. Traceback has begun, on-site inspection has been initiated, and … [Read more...]

Real Water Ordered To Stop Distributing Adulterated Real Water Products

Real Water ordered to stop distributing adulterated Real Water products by a federal court. The U.S. District Court for the District of Nevada has permanently enjoined AffinityLifestyles Inc. and Real Water Inc. from preparing, processing, and distributing adulterated and misbranded bottled water. The water is allegedly the only common link between five children who developed non-viral hepatitis¬†and acute liver failure in late 2020. The alkaline water products may also be associated with non-viral hepatitis cases in seven adults. The water products were marketed as a healthy alternative to tap water, but the government alleges that the products consisted of municipal tap water that the defendants processed with various chemicals in violation of good manufacturing practices, relevant … [Read more...]

Real Water Ceased Operations After Non-Viral Hepatitis Outbreak

The FDA has announced that Real Water ceased operations after the non-viral hepatitis outbreak associated with their alkaline water may have sickened at least 16 people. According to a consent decree complaint, the company allegedly failed to comply with FDA manufacturing requirements. U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction on June 1, 2021 between the United States and AffinityListstyles.com Inc, which is the majority shareholder of Real Water Inc. According to the compliant filed by the Department of Justice on behalf of the FDA, the defendants allegedly violated the FD&C Act by operating facilities that failed to meet preventive controls requirements to control food hazards. The complaint also alleges that the products are … [Read more...]

Real Water Hepatitis Outbreak Increases to 11 Sick and 1 Probable Case

The Real Water hepatitis outbreak has increased to 11 people sick and 1 probable case, according to an update from the FDA. This is a non-viral hepatitis outbreak, which means that particular brand of alkalized water may have caused liver inflammation. This outbreak is not caused by the contagious hepatitis virus. The one probable case meets the case definition but has not been tested for viral hepatitis to rule that out. There are three kinds of non-viral hepatitis. The first is caused by consuming too much alcohol; the second is an auto-immune disease where the immune system attacks the liver; and the third is caused by chemicals, prescription and non-prescription medications, and nutritional supplements. This is an increase of six new cases since the last update was released … [Read more...]

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