A preterm infant has died after receiving Evivo with MCT Oil probiotic in the hospital. That dietary supplement, produced by Infinant Health, is formulated to contain the live bacterium Bifidobacterium longum subsp. infantis, according to the FDA. The infant developed sepsis caused by that bacterium. The FDA is investigating this death. Genomic sequencing data found … Read more
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 … Read more
A dietary supplement executive has been sentenced to prison in a Texas federal court for his role in fraudulently seeing popular workout supplements, according to the U.S. Department of Justice. Former S.K. Laboratories Vice President Sitesh Patel of Irvine, California, was sentenced to 41 months imprisonment and one year of supervised release by U.S. District … Read more
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 … Read more
The FDA Is issuing a public health alert about dietary supplements that contain cesium salts, primarily cesium chloride. This ingredient has significant safety risks, including heart toxicity and potential death. The FDA is also alerting health care professionals about the risks of cesium salts, which are sometimes promoted as alternative treatments for cancer. Cesium salts … Read more
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 … Read more
The FDA has issued a warning to consumers to avoid Miracle or Master Mineral Solution, since they have received many reports that these products have made consumers sick. The government first warned consumers about these products in 2010, but they are still being promoted on social media and sold online by independent outlets. These products … Read more
The U.S. District Court for the District of Colorado has entered a permanent injunction against EonNutra LLC, two related companies, CDSM LLC and HABW LLC, and their owner, to prevent the distribution of “adulterated and misbranded dietary supplements and unapproved and misbranded drugs.” The Department alleges that the defendants, who sell about 150 dietary supplement … Read more
Ton Shen Health/Life Rising Corporation of Chicago expanded a recall of “DHZC-2” Tablets to include all lots purchased before August 24, 2016 after state and federal health authorities said they were investigating six reports of adverse effects associated with the herbal supplement including the illnesses of two children and the possibility of two deaths. Health officials … Read more
A U.S. District Judge for the Middle District of Florida, James S. Moody, Jr. has entered a consent decree of permanent injunction between the United States and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements, for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes … Read more