December 10, 2019

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...]

Smart Lipo Recalled for Undeclared, Banned Drugs

SmartLipo365 of Dallas is recalling all lots of Smart Lipo capsules because they have been found to contain contain undeclared, banned drugs. Consumers who have purchased these products should not use them as they could cause serious, life-threatening health problems. All 800, 900 and 950 mg capsules are being recalled after the U. S. Food and Drug Administration (FDA) conducted an analysis and found them to contain sibutramine, desmethylsibutramine, and phenolphthalein which are not declared on the label. Sibutramine is banned drug.  Before it was removed from the market in 2010 for posing health risks to patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke, it was used as an appetite suppressant. Phenolphthalein is a banned drug … [Read more...]

NPA Questions Tests on NY’s Herbal Supplements Probe

The CEO of the Natural Products Association (NPA) is questioning the testing methods used in the New York Attorney General's probe of herbal supplements. Show us the data, he says. Last week, New York Attorney General Eric T. Schneiderman sent cease and desist letters to GNC, Target, Walmart, and Walgreens after tests on their store brand herbal supplements tests showed most did not contain the contain plant species identified on the label. And some contained contaminants not identified on product labels. Because supplements do not have to undergo a premarket evaluation by the U.S. Food and Drug Administration (FDA) before they are sold,  manufacturers are responsible for ensuring that their products are safe and accurately labeled. Undeclared ingredients can interfere with … [Read more...]

Walgreens Pulls Phony Herbal Supplements; Walmart, Target, GNC Keep Selling

After tests showed their store-brand herbal supplements did not to contain the herbs on their labels,  Walmart, Walgreens Target and GNC all received cease and desist letters from New York Attorney General Eric T. Schneiderman yesterday.  Only Walgreens has responded by pulling the products. Walmart Target and GNC issued statements that they were looking into the matter. While they do, their shoppers cam feel free to shell out $8-$10 on bottles full of sand, allium, pine, wheat/grass, rice mustard, citrus, dracaena (houseplant) or cassava (tropical tree root), but labeled Ginseng, Garlic, St John' Wort or Echinacea. Because that's what the tests found. According to Schneiderman's office,  79 percent of herbal products tested did not contain plant species identified on the label. And … [Read more...]

NY AG Takes Aim at At GNC, Target, Walmart, Walgreens Herbal Supplements

New York Attorney General Eric T. Schneiderman has asked GNC, Target, Walmart, and Walgreens to stop selling their store brand herbal supplements immediately because of mislabeling. Cease and desist letters sent to the companies yesterday say tests on the products found 79 percent  did not contain plant species identified on the label. And some contained contaminants not identified on product labels. Supplements do not have to undergo a premarket evaluation by the U.S. Food and Drug Administration (FDA) before they are sold. Manufacturers are responsible for ensuring that their products are safe and accurately labeled. Unfortunately, not all of them do. In fact, many supplements, especially those sold as weight loss or body building supplements, contain undeclared ingredients that … [Read more...]

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