August 14, 2022

FDA Warns of Dietary Supplements with Live Yeast in Immunocompromised Persons

The FDA is warning those who are immunocompromised against taking dietary supplements that contain live bacteria or yeast and is warning healthcare providers about the use of these products in susceptible patients. A premature infant who was given ABC Dophilus Powder as part of an in-hospital treatment developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae mold was found in an unopened container of the ABC Dophilus Powder. The FDA has sent a letter to healthcare providers around the country regarding this issue. That product was recalled on November 14, 2014 by the FDA for the mold. After the infant's death, FDA is telling healthcare providers that dietary supplements are not regulated as drugs by the FDA. They are not subject to FDA's … [Read more...]

Mixing Dietary Supplements and Meds Is a Danger

The Food and Drug Administration, in one of its Consumer Updates, reminds you that mixing medications and dietary supplements can endanger your heath. Robert Mozersky , a medical officer at the FDA said, "Some dietary supplements may increase the effect of your medication, and other dietary supplements may decrease it." Dietary supplements can change metabolism, absorption, and excretion of a medication and affect how it works. Mozerky added, "you may be getting either too much or too little of a medication you need." One example of a supplement that interacts with prescription medications is St. John's Wort. That supplement, which is often taken for depression, can make meds for HIV/AIDS, heart disease, depression, birth control pills, and treatments for organ transplants less … [Read more...]

Green Coffee Bean Supplement Maker Settles FTC Charges

The Federal Trade Commission has settled with Applied Food Sciences, Inc. on charges that it used the results of a flawed study to market baseless weight-loss claims about its green coffee extract. The FTC stated that the study was "so hopelessly flawed that no reliable conclusions could be drawn from it." The flawed study was promoted on the Dr. Oz Show. The settlement requires the company to pay $3.5 million and to have scientific substantiation for any future weight-loss claims it makes, including at least "two adequate and well-controlled human clinical trials." The company made the false claims to retailers, who repeated the claims to consumers. Jessica Rich, Director of the FTC's Bureau of Consumer Protection said in a statement, "Applied Food Sciences knew or should have known … [Read more...]

FDA: Dietary Supplements Don’t Treat Concussions

Despite claims by some manufacturers, dietary supplements do not treat concussions, the U.S. Food and Drug Administration (FDA) wants consumers to know. Especially, parents of kids involved in football, soccer and other fall sports. A concussion is a traumatic brain injuries (TBI) caused by a blow to the head, or by violent shaking of the head or upper body. TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional, says the FDA, which is warning consumers to avoid dietary supplements that claim to prevent, treat, or more quickly heal concussions. "We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready … [Read more...]

FDA Issues Warning About Weight Loss Product Zi Xiu Tang Bee Pollen

Zi Xiu Tang Bee Pollen, a product marketed for weight loss and body shaping, contains one or more harmful pharmaceutical ingredients not listed on the label and should not be taken by consumers,  the U.S. Food and Drug Administration (FDA) is warning.  The FDA has tested Zi Xiu Bee Pollen products from various distributors in the United States and all of them contain undeclared  sibutramine or phenolphthalein which have both been banned for their harmful side effects. The FDA has received dozens of reports of adverse effects associated with the use of this product including heart palpitations, increased heart rate, increased blood pressure, chest pain, diarrhea, anxiety, insomnia,  suicidal thoughts, and seizure. Consumers who have experienced negative side effects while taking this … [Read more...]

StemAlive Capsules Recalled for Undeclared Milk

Stemvida International Corporation of Ontario, CA is recalling StemAlive capsules sold in 90-count bottles because they contains undeclared milk. People with an allergy or severe sensitivity to milk should not consume this product as they run the risk of serious or life-threatening allergic reaction. The product was packaged in a white plastic bottle with white lid. The brand name StemVida International appears on the white and gold label. It was distributed to the following states: Arizona, California, Colorado, Florida, New Jersey, New York, Nevada, Oklahoma, Texas and Utah. No illnesses have been reported to date. The lot number and expiration date is printed in black ink at the bottom of the label. The products under recall have the following lot numbers and expiration dates: … [Read more...]

FDA Commissioner’s Take on Caffeine in Food and Supplements

How much caffeine should be allowed in food, beverages and supplements? In August 2013, the Institute of Medicine (IOM), an independent nonprofit organization, held a public workshop on that topic at the request of the U.S. Food and Drug Administration's (FDA). Today the IOM issued a 164-page summary about the workshop. The report does not make recommendations, but describes the risks associated with caffeine consumption and explores safe levels of consumption. The workshop was prompted by the sudden boom in caffeine-added products including gum, candy, snacks, energy drinks, supplements and bottled water. A safe level of caffeine has never been determined for those products. The only time the FDA has approved the use of added caffeine was for cola. That was in the 1950s. "In the … [Read more...]

Dietary Supplement Industry Largely Unregulated

There is a lot of confusion about the dietary supplement industry, what products they are allowed to sell, and how they are regulated. Before 1990, supplements were mainly just vitamins and minerals. Interest peaked in the early 1990s, and more manufacturers got into the business.  Congress wanted to strengthen the FDA's enforcement powers over misleading claims and unscrupulous manufacturers. But in 1994, outfits such as Mercola and other supplement supporters got the Dietary Supplement Health and Education Act passed. It was heavily supported by the supplement industry. In addition, companies got consumers involved, telling them that the government was going to take away their supplements. That was a lie. A huge groundswell of public opinion helped get the Act passed. Dietary … [Read more...]

FDA: Tell Us If You’ve Been Injured By A Dietary Supplement

If you've been injured by a dietary supplement, the U.S. Food and Drug Administration (FDA) wants to know about. The agency announced today that it is now accepting online submissions of reports about adverse health events triggered by the use of dietary supplements. Both voluntary and mandatory reports can now be submitted online. To make a report, click here. According to the Dietary Supplement and Nonprescription Drug Consumer Protection Act,  if a manufacturer, packer, or distributor's name appears on the label of a dietary supplement,  the company must share with the FDA any reports of serious adverse events associated with the use of the product. There are more than 85,000 dietary supplements on the market. In terms of regulation, the FDA considers them food, not drugs and … [Read more...]

Buyer Beware: Supplements, Energy Drinks Don’t Need FDA Approval

Do you know what’s in that dietary or sports supplement you’re taking? Is that energy drink you bought at the checkout counter safe? Maybe not. Energy drinks and supplements, including those marketed as diet or sports aids, fall into the “food” category of products regulated by the U.S. Food and Drug Administration (FDA). Food producers aren’t required to provide the FDA with evidence of a product’s safety before selling it. And while food labels are supposed to accurately reflect ingredients and make no false claims about health benefits, some supplement makers skirt these rules causing dire health problems for the unsuspecting consumers who take them. Dietary supplements have been linked to cases of liver damage and death. In fact, a recent study by the Drug-Induced Liver Injury … [Read more...]

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