September 18, 2020

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...]

SNI Recalls Kratom Dietary Supplements for Undeclared Drugs

SNI National is recalling all Kratom products because they contain Kratom (Mitragyna Speciosa), which is a new ingredient for which there is "inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury." Scientific literature shows serious concerns about the toxicity of Kratom in organ systems. Consumption of these products may lead to "respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms," according to the FDA release. The primary ingredient doesn't fall under the Federal Food, Drug, and Cosmetic Act as having all the information … [Read more...]

Pain Free by Nature Recalling Reumofan Plus Tablets

Pain Free by Nature of C0lorado is recalling "Reumofan Plus" Tablets because they contain the undeclared active pharmaceutical ingredients methocarbamol and diclofenac. Taking this product could result in serious and life-threatening injuries. Methocarbamol is a muscle relaxant available only by prescription. Diclofenac is a prescribed NSAID that can cause sudden heart attacks, strokes, bleeding ulcers, and holes in the stomach and intestine. Reumofan Plus is a treatment for muscle pain, arthritis, osteoporosis, bone cancer, and other medical conditions. The product is packaged in a green and gold box in 30 tablet containers. It was distributed nationwide through internet sales. The recall was initiated after the FDA discovered the packaging didn't reveal the presence of the active … [Read more...]

Weight Loss Supplement Fruta Planta Recalled for Unapproved Drug

MyNicKnaxs of Florida is recalling Reduce Weight Fruta Planta because it contains Phenolphthalein, making the supplement an unapproved new drug. Phenolphthalein was once used in over the counter laxatives, but it was banned because of concerns of carcinogenicity. Consumption of this product could cause serious gastrointestinal disturbances, irregular heartbeat, and cancer. All lots of Reduce Weight Fruta Planta are recalled. The product contains 10.2 mg of Phenolphthalein. No illnesses or injuries have been reported to date. If you purchased this product, stop using it immediately. Return it to the place of purchase for a refund. If you have experienced side effects or adverse reactions associated with this product, report to FDA's MedWatch Adverse Event Reporting program. … [Read more...]

Mega Slim Dietary Supplement Recalled for DMAA

YoungYou International is recalling Mega Slim Herbal Appetite Management, a dietary supplement, because it contains DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is dangerous to your health. It can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest, or heart attack. The chemical is an unapproved dietary ingredient. Mega Slim Herbal Appetite Management is packaged in white bottles with 30 white capsules. The lots include the bar code 736211614094 and an expiration date of June 2014. The product was only sold through the YoungYou web site. If you purchased this product, do not take it. Return it to the company for a refund. The company is only issuing refunds to customers who … [Read more...]

Dietary Supplements Can’t Treat Concussion

The FDA is warning consumers that, despite claims to the contrary, dietary supplements can't treat concussion. Some companies are offering "untested, unproven and possible dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs). FDA is monitoring the marketplace and taking enforcement action where they feel it is appropriate. They will issue warning letter to companies as necessary as the first step. Warning consumers is another step. Finally, the FDA can go to the courts and get an injunction against a corporation making supplements with unproven or misleading claims, forcing them to stop production and recall the product. One common claim made by some corporations is that using a particular dietary supplement can promote faster … [Read more...]

Burn 7 Capsules Recalled for Undeclared Sibutramine

Deseo Rebajar, Inc. is recalling Burn 7 Capsules, a dietary supplement to promote weight loss, because it contains undeclared Sibutramine. That is a previously controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The drug substantially increases blood pressure and/or pulse rate in some people. It may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The recalled product is Burn 7 capsules with lot #MFD: 07.18.2013 (Exp: 07.17.2015). The product was sold directly to customers from the company offices in Fajardo, Caguas and Bayamon, and through the company's website. If you purchased this product, do not use it. Return it to the place of purchase for a refund. If … [Read more...]

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