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...]
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...]
Fusion Health Is Ordered to Stop Selling Covid-19 Vitamin D Treatments
Fusion Health is ordered to stop selling Covid-19 Vitamin D products by the U.S. Department of Justice,. Two other companies also owned by Matthew Ryncarz, Vitality LLC doing business as Pharm Origins, and Fusion Ionz LLC doing business as Pharm Origins, are included in the complaint. These companies allegedly sold and distributed products that the defendants claimed would "cure, mitigate, or treat COVID-19 and other diseases." Several products were sold that supposedly contained Vitamin D3, such as "Immune Shot," "Immune Boost," and "Core." None of these products are generally recognized as safe and effective by qualified experts, according to the complaint. Deputy Assistant Attorney General Daniel J. Feith said in a statement, "The Department of Justice will not allow … [Read more...]
FDA Stops Sales of Nano Silver as False COVID-19 Treatment
The FDA stops sales of Nano Silver as false COVID-19 treatment through a civil complaint for permanent injunction. The complaint was filed on November 13, 2020 in U.S. District Court for the District of New Jersey. The U.S. is alleging that Natural Solutions Foundation sold and distributed a nano silver product that the defendants claim will "cure, mitigate, treat, or prevent COVID-19." Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division said in a statement,“The Department of Justice will not allow individuals to take advantage of the ongoing public health emergency by peddling unproven, unapproved drugs. We will continue to work closely with the Food and Drug Administration to halt the illegal sale of such products during this … [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...]
Permanent Injunction Against Sundial Herbal Products For Unapproved Drugs
A federal judge has entered an order of permanent inunction against Sundial Herbal Products to stop distributing their products because they have been labeled unapproved new drugs and misbranded drugs. Despite previous warnings from the FDA, the company "continued to violate the law and distributed their products," according to a new release issued by the FDA. FDA Chief Counsel Stacy Amin said in a statement, "Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases places consumers’ health at risk. We remain committed to pursuing and taking swift action against those who attempt to subvert the regulatory functions of the FDA by repeatedly disregarding the law and … [Read more...]
Blue Bell Pleads Guilty in Ice Cream Listeria Monocytogenes Outbreak
Blue Bell pleads guilty in ice cream Listeria monocytogenes outbreak and pays $19.35 million. And a former company president has been charged in connection with a scheme to allegedly cover up the incident, according to the Justice Department. The charge is that the company shipped contaminated and adulterated product. That deadly outbreak covered a five year time span from 2010 to 2015 that sickened 10 people. All of the patients were hospitalized. Three people who lived in Kansas died. Eight of the patients were hospitalized when they were served contaminated Blue Bell ice cream. The outbreak strain of Listeria monocytogenes were found in ice cream made at the Blue Bell plants in Brenham, Texas and Broken Arrow, Oklahoma. This outbreak was long and complicated; we have put together … [Read more...]
Consent Decree Against PA Miller’s Organic Farm For Avoiding Inspections
A consent decree has been issued against Miller's Organic Farm of Bird-in-Hand, Pennsylvania for violating USDA laws by avoiding inspections and misbranding meat and poultry. In November 2019, the U.S. government permanently enjoined the company and its owner, Amos Miller, for obstructing federal health and safety oversight and from selling uninspected meat to the company's nationwide "private membership association." USDA inspectors and investigators went to the farm in December 2019 to assess compliance with the injunction. They found 2,000 pounds of fresh meat carcasses that Miller's had slaughtered without federal inspection, in violation of the injunction. FSIS tagged the meat so it couldn't be used or sold, but Miller's voluntarily destroyed them. FSIS fond more violations … [Read more...]
Injunction Filed Against MI Home Style Foods by FDA
Home Style Foods, a seafood and salad processor in Hamtramck, Michigan has been enjoined against producing and distributing ready-to-eat seafood salads, non-seafood salads, pierogis, and dips because they were processed under insanitary conditions, according to the Department of Justice. The complaint was filed on January 13, 2020 against the company and the company's president, Michael J. Kowalski. The complaint states that the company "violated the Food, Drug and Cosmetic Act by processing and distributing fish products and other food, including salads, pierogis, and dips, in a facility where government inspectors previously found evidence of Listeria contamination. The complaint also alleged violations of seafood safety regulations designed to mitigate hazards associated with … [Read more...]
Judge Strikes Down Iowa Ag Gag Law
A federal judge struck down Iowa's ag gag law last week. Those laws make it illegal for animal rights advocates to go undercover to expose animal abuse at farms and puppy mills. The 2012 law was approved by Iowa lawmakers, and carried a fine of up to year in jail. ACLU legal director Rita Bettis Austen said the ruling was "an important victory for free speech." She also said that the law was an example of government using its power to protect those in power. She added, "Ag gag clearly is a violation of Iowans' First Amendment rights to free speech. It has effectively silenced advocates and ensured that animal cruelty, unsafe food safety practices, environmental hazards, and inhumane working conditions go unreported for years." The Animal Legal Defense Fund was one of the … [Read more...]
