September 26, 2016

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. “This case reminds us again that dietary supplements are not regulated as drugs by the FDA," said Elliot Olsen, an attorney with law firm PritzkerOlsen, who has represented … [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 Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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...]

CSPI: FDA Should Ban Retail Sale of Bulk Caffeine

The Center for Science in the Public Interest is saying that the FDA should ban the retail sale of bulk caffeine as a dietary supplement. Parents of two young men who died after ingesting this product met with FDA officials and senators to press their cause. CSPI is formally petitioning the FDA over this issue. >Katie and Dennis Stiner of Ohio lost their 18 year old son Logan in May of this year. James and Julie Sweatt of Alabama lost their 24 year old son Wade in July 2014 after he ingested caffeine powder for the first time. One teaspoon of powdered caffeine is equivalent to 25 cups of coffee. It is very difficult to determine the difference between a safe dose and a deadly dose when caffeine is used in this form. Serving sizes are between 1/32 and 1/16 of a teaspoon - amounts that … [Read more...]

ABC Dophilus Powder Recalled for a Fungus

Solgar, Inc. of New Jersey is recalling ABC Dophilus® Powder, a dietary supplement, because it contains Rhizopus oryzae, a fungus that causes Mucormycosis, a rare infection. This infection can cause health problems in premature infants, children, and anyone with a weakened immune system. Otherwise healthy people can also become ill if they ingest this fungus. One consumer complaint has been received to date. The product is Solgar ABC Dophilus® Powder, NET Wt. 1.75 oz (50 grams). The UPC number is 0 33984 00010 0 and the Lot Numbers are 074024-01R1, 074024-01, and 074024-02, with Expiration Date 7/31/15. It was sold in AL, AR, AZ, CA, CT, CO, FL, IA, IL, IN, MI, ME, MO, MA, NC, NE, NY, NJ, NV, OH, OK, PA, PR, UT, TN, TX, VT, KY, WI, WA, UK, and Israel through pharmacies, retail … [Read more...]

FDA Issues Sit and Slim II Warning for Unapproved Drugs

The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II which contains the unapproved drugs sibutramine and phenolphthalein. The product is marketed as a weight loss aid. Sibutramine was removed from the market in October 2010 for safety reasons. The product poses a health threat to consumers because it can substantially increase blood pressure and pulse rate. This poses serious problems for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The drug can also interact with other medications and cause a  life-threatening situation. Phenolphthalein is an unapproved drug in the United States. Studies have shown that it presents a cancer-causing risk. Health care professionals and … [Read more...]

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