June 26, 2022

FDA Updates Activities on Infant Formula Supply Challenges

The FDA has updated its activities on infant formula supply challenges. The agency is trying to increase the supply and availability of infant formula since the Abbott Nutrition plant in Sturgis, Michigan closed because the FDA found Cronobacter contamination in the environment. The agency warned parents not to use certain powdered infant formula products from that facility on February 17, 2022. A recall was issued by Abbott the same day. Cronobacter is a bacteria that can cause serious illness and death in infants, particularly premature babies and those with other medical conditions. A consent decree of permanent injunction was filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. Abbott has agreed to take corrective actions following the FDA … [Read more...]

Bravo Packing Ordered to Stop Distribution of Adulterated Pet Food

Bravo Packing has been ordered by the courts to stop distributing pet food adulterated with Salmonella bacteria. This order was on behalf of the FDA. The complaint was filed on March 15, 2022 and alleges that Bravo Packing violated the Federal Food, Drug, and Cosmetic Act by distributing animal food that was contaminated with pathogens, and by causing animal food to become adulterated while it was held for sale.   Samples that were collected by the FDA during inspections of the Bravo Packing facility in July 2019 and April 2021 allegedly contained Salmonella, a pathogen that can cause serious illness in both pets and humans. Salmonella can be transferred to people from animal food through handling of the food or through direct contact with infected animals. Principal … [Read more...]

Felix Custom Smoking Enjoined From Distributing Seafood Products

Felix Custom Smoking has been enjoined from distributing seafood products through a consent decree filed on March 9, 2022 by the FDA and the U.S. Justice Department. The owner of that establishment, Diane Zollinger, has allegedly violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing "adulterated ready-to-eat seafood products, including fish jerky and cold- and hot-smoked salmon," according to the complaint. The business sells products directly to consumers from its location and through farmers markets, as well as providing custom processing for fishermen and other wholesalers. The facility is located in Monroe, Washington. The claims made in the complaint are allegations that, if the case were to proceed to trail, the government must prove by a preponderance of … [Read more...]

Consent Decree Against Salud Natural Entrepreneur Supplements

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...]

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