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...]
Dietary Supplement Executive Sentenced For Fraudulent Sales
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 Juge Sam A. Lindsay. According to documents that were filed intros case, Patel "Patel played a key role in developing and manufacturing the popular workout and weight loss supplements known as Jack3d and OxyElite Pro, which were distributed by Dallas-based USPlabs." Patel and several co-defendants admitted that they imported substances "with false and misleading labeling to avoid law enforcement and regulatory agency … [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...]
FDA Alerts Consumers to Dangers of Cesium Salts in Supplements
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 have never been proven to be safe and effective to treat cancer or for any other use. While only a few dietary supplements on the market contain this ingredient, consumers should not purchase those products. According to the alert, there have been"multiple clinical case reports and non-clinical studies show significant safety concerns related to the use of such products, including potentially fatal cardiac … [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...]
FDA Warns Against Miracle or Master Mineral Solution; Illnesses Reported
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 are marketed under various names, including Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, and Water Purification Solution (WPS). When these products are mixed according to package directions, they become a chemical that is used as bleach. In addition, some of the distributors are making false and dangerous claims that Miracle Mineral Supplement, when mixed with citric acid, acts as an … [Read more...]
Permanent Injunction Closes Dietary Supplement Makers
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 products, violated the Federal Food, Drug, and Cosmetic Act. Several of those products were labeled as dietary supplements, but were marketed as drugs. The company claimed that the product could help treat or prevent diseases such as "heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders." According to the complaint, the defendants offered these claims to the public without … [Read more...]
Ton Shen/ Life Rising Recalls all DHZC-2 Tablets After Reports of Illnesses, Deaths
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 say the product, which was sold nationwide in retails stores and distributed through mail orders, may be contaminated with elevated levels of lead, a toxic substance. Exposure to anything but small amounts of lead can cause lead poisoning. Symptoms of lead poisoning include abdominal cramps, vomiting, fatigue, irritability, muscle weakness, behavior or mood changes, delirium, seizures, and coma. In young children, … [Read more...]
Dietary Supplement Distributor Ordered to Stop Selling Product
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 a civil fraud charge, by promoting the product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to support the claims. Hill was sent a warning letter in April 2011, stating that the therapeutic claims he is making are untrue. The FDA has not approved the product for any use. The product was marketed as a treatment for herpes. In addition, the … [Read more...]
Pink Bikini Supplements Recalled for Undeclared, Banned Drugs
Lucy's Weight Loss System of Arlington, Texas, is recalling all lots of Pink Bikini and Shorts on the Beach Capsules because they contain an undeclared, banned ingredient. Consumers who have purchased this product should not use it. The recall includes all colors, 30 count, 750MG per capsules. The U.S. Food and Drug Administration (FDA) found these products contain Sibutramine, Phenolphthalein, and/or Diclofenac, which are not declared on the label. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. It is known to substantially increase blood pressure and/or pulse rate. Phenophthalein is an ingredient previously used in over-the-counter laxatives, that was removed from the market after it was found to cause cancer. Diclofenac is a … [Read more...]
