A consent decree has been issued against Salud Natural Entrepreneur, Inc. (Salud) for allegedly distributing adulterated and misbranded dietary supplements and unapproved new drugs. The company allegedly claimed that theoe products would cure, mitigate, treat, or prevent diseases such as cancer, diabetes, heart disease, and high blood pressure. The decree was filed by the Department of Justice in the Northern District of Illinois on March 3, 2022 on behalf of the FDA. The decree also alleges that Salud did not comply with current Good Manufacturing practices regulations that are designed to help ensure the safety of nutritional supplements. And also, the decree alleges that on one occasion Salud used ingredients that had tend positive for Salmonella bacteria in manufacturing a … [Read more...]
Natural Solutions Foundation Must Stop Distributing COVID Treatment
A federal court permanently enjoined Natural Solutions Foundation, a New Jersey entity, and its principals from distributing unapproved and misbranded drugs that were marketed as a treatment for COVID-19. The company was distributing a "nano silver" product that they claimed would prevent, treat, or cure COVID-19. The enforcement action was prosecuted by Trial Attorney Brianna M. Gardner of the Civil Division’s Consumer Protection Branch, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA’s Office of Chief Counsel. The complaint was filed at the request of the FDA, and states that nano silver is not generally recognized by qualified experts as safe and effective to prevent, treat, or cure COVID-19, and that these claims are not supported by … [Read more...]
U.S. Grandma’s Herbs Consent Decree of Permanent Injunction
A consent decree of permanent injunction has been entered between U.S. Grandma's Herbs, Inc. of St. George, Utah, and the company's owners. The company allegedly marketed products as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs, according to an FDA news release. The U.S. District Court for the District of Utah entered the consent decree on behalf of the FDA. The FDA has not approved Grandma's Herbs products for any use. The company has claimed that the products could be used to "diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy." Judy McMeekin, Pharm.D., FDA’s associate commissioner for regulatory affairs said in a statement, "The … [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...]
Valley Processing Ordered To Stop Producing Adulterated Juices
The U.S. District Court for the Eastern District of Washington entered a consent decree between the FDA and Valley Processing of Sunnyside, Washington to stop the company from distributing adulterated juice products until they comply with the Federal Food, Drug, and Cosmetic Act. The complaint, filed on November 6, 2020, states that Valley Processing juice products allegedly contained inorganic arsenic and patulin toxins at levels that can cause health problems. This juice was distributed for use in school lunch programs. This consent decree prohibits Valley Processing from receiving, preparing, processing, packing, holding, labeling, and/or distributing FDA regulated products until it completes corrective actions. The company had stopped its juice processing activities, but they … [Read more...]
FDA Sues Valley Processing For Heavy Metal in Juice, Insanitary Conditions
According to press reports, the FDA is suing Valley Processing of Sunnyside, Washington because the company allegedly is not monitoring for toxic heavy metals in its juice products and producing under insanitary conditions. Valley Processing supplies juices to the national school lunch program. Three million servings of the company's juice products were distributed every year to the federal school lunch program. The lawsuit was filed November 6, 2020 in the U.S. District Court of Eastern Washington. The lawsuit states that the company allegedly ignored years of notifications from inspectors about issues that put kids at risk of consuming products that were "injurious to health." The company has agreed to a consent decree. The lawsuit states, "Defendants’ juice products are … [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...]
Golden Gate Soy Products Shut Down For Listeria Monocytogenes
The FDA announced that Golden Gate Soy Products, a food manufacturer based in California, is discontinuing selling food products until the company complies with federal regulations. FDA inspections at the company's facility found Listeria monocytogenes bacteria in the food preparation area and that the company was holding food for distribution under insanitary conditions. There is zero tolerance for Listeria monocytogenes contamination in ready-to-eat products. The pathogen can become very hard to remove when it becomes established in a facility, especially when conditions are wet or damp. U.S. Magistrate Judge Jacqueline Scott Corley for the Northern District of California entered a consent decree of permanent injunction on November 22, 2019. Golden Gate Soy Products … [Read more...]
Consent Decree Against Biogenyx and Basic Reset For FD&C Act Violations
A federal court has ordered two Tennessee-based companies to stop distributing drugs, dietary supplements, and devices until the companies comply with the Federal Food, Drug, and Cosmetic Act (FD&C). The companies are Biogenyx and Basic Reset. The FDA has not approved these drugs or devices "for any use, despite the companies’ claims that these products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain." In addition, those companies have unlawfully distributed dietary supplements that are adulterated and misbranded, according to the decree. During inspections at the facilities, FDA inspectors found numerous violations of the Current Good Manufacturing Practices … [Read more...]
Saranac Brand Foods Enjoined From Distributing Foods After Listeria Found in Plant
A federal court has permanently enjoined Saranac Brand Foods of Saranac, Michigan from "preparing, processing, and distributing adulterated ready-to-eat foods," according to a press release from the U.S. Department of Justice. The complaint was filed on November 29, 2018 at the request of the FDA, and the finding was entered today, Monday, December 3, 2018 by the United States District Court for the Western District of Michigan. The FDA alleges that Saranac Brand Foods violated the Federal Food, Drug, and Cosmetic Act by putting adulterated ready-to-eat foods into commerce. The company prepared and distributed about 35 foods, including dips, sauces, and salads such as spinach dip, macaroni salad, enchilada sauce, and coleslaw. Assistant Attorney General Jody Hunt of the … [Read more...]
