More Tejocote supplements are being recalled because they actually contain yellow oleander, a toxic plant. There is no information on the recall notice if anyone has reported adverse reactions, because the notice was posted on the FDA's Enforcement Reports page. The recalling firm is HandNatural of San Luis, Arizona. Yellow oleander, which is a poisonous plant found in Central America and Mexico, can cause many adverse health effects. The seed looks very similar to tejocote. People who consume yellow oleander may suffer from nausea, vomiting, diarrhea, abdominal pain, dizziness, heart changes, arrhythmia, and more. These neurological, gastrointestinal, and cardiovascular health issues can be serious or fatal. You can see the long list of recalled products along with the package … [Read more...]
More FDA Warnings About Yellow Oleander in Supplements
The FDA is issuing more warnings about yellow oleander in supplements. So far, 18 dietary supplements have been identified as problematic. Yellow oleander is a toxic plant and can cause serious health problems that can be fatal. One of the issues is that some of the firms that produce and/or distribute these products are refusing to issue recalls. The agency is still communicating with those firms about this issue. And the FDA is evaluating any regulatory pathways they have to remove these products from the marketplace. The FDA has found that some products marketed as tejocote root, which can be identified as Crataegus mexicana, Raiz de Tejocote, and Mexican Hawthorn, may contain yellow oleander. The plant can cause serious problems with the cardiovascular, gastrointestinal, and … [Read more...]
5 Star Nutrition Distributed Misbranded Dietary Supplements
According to the Justice Department, Defyned Brands, also known as 5 Star Nutrition, distributed misbranded dietary supplements. The company pled guilty to a three count information charging it with that action. The company admitted that from September 2018 to July 2020, it delivered into interstate commerce misbranded dietary supplements, which are considered a type of food under the Federal Food, Drug, and Cosmetic Act. The specific admission was that shipments of products known as Epivar, Alpha Shredded, and Laxobolic were misbranded. They allegedly contained ingredients that were mislabeled as supplements or were not listed on the product label. The products were marketed as dietary supplements. They were sold at 5 Star Nutrition Retail locations. The company has agreed to … [Read more...]
FDA Warns About Probiotics For Hospitalized Preterm Infants
The FDA warns about probiotics for hospitalized preterm infants. A preterm baby died earlier this month after receiving Evivo with MCT Oil probiotic in the hospital. The government is concerned about the risk that products with live bacteria pose to preterm infants. A letter was recently sent to healthcare providers warning them about this problem. The agency also issued two warning letters to companies for illegally selling their products for treating or preventing disease in preterm infants. Probiotics contain live bacteria or yeast and are usually marketed as foods or dietary supplements. The FDA says that infants can develop sepsis if they are given these products. Some companies are illegally selling probiotics to treat or prevent diseases such as reducing the risk of … [Read more...]
FDA Warns Companies Selling Supplements For Heart Disease
The FDA is warning seven companies for allegedly illegally selling dietary supplements for heart disease. The FDA says that these corporations claim that their products cure, treat, mitigate, or prevent cardiovascular disease or related conditions, such as stroke, atherosclerosis, or heart failure. These products are considered unapproved new drugs and have not been evaluated by the FDA for safety and efficacy. The warning letters were sent to these companies: Essential Elements (Scale Media Inc.) Calroy Health Sciences, LLC Iwi BergaMet North America, LLC Healthy Trends Worldwide, LLC (Golden After 50) Chambers' Apothecary Anabolic Laboratories, LLC The CDC states that cardiovascular disease is the leading cause of death in this country. In 2020, almost … [Read more...]
Court Enjoins Company From Distributing Adulterated Supplements
A federal court has permanently enjoined an Arizona company from distributing adulterated supplements. The complaint, which was filed on October 12, 2022, enjoined Global Vitality, Inc., doing business as Enzyme Process International, from distributing these adulterated supplements, which were also misbranded. The complaint was filed in the U.S. District Court of the District of Arizona. FDA alleges that inspectors visited the Global Vitality facility in Chandler, Arizona many times, in 2012, 2014, 2016, 2019, and in June and July 2021, and found violations of regulatory requirements meant to control the risk of hazards in dietary supplements. The government also alleges that the company failed to follow current good manufacturing practices for dietary supplements. In addition, a … [Read more...]
Some Imported Dietary Supplements and Drugs May Harm You
Some imported dietary supplements and nonprescription drugs may harm you, according to the FDA. Consumers buy these products from ethnic stores, international stores, flea markets, swap meets, or purchase them online. Scammers often target ads to people who prefer to shop at these nontraditional places. And those companies know that some groups who may not speak or read English well can be targets. Many of these consumers have long traditions of using herbal remedies, so these corporations put the word "natural" on the packaging, thinking it will inspire trust. But natural does not mean safe. And even if a label says "natural," the product could still have hidden drugs and other dangerous ingredients. Or they could contain potentially harmful chemicals that are not on the … [Read more...]
FDA Starts Dietary Supplement Education Initiative
The FDA has started a Dietary Supplement Education Initiative to help consumers understand the risks and benefits of these products. The program, called Supplement Your Knowledge, offers fact sheets and educational material. More than half of Americans take dietary supplements. These products are regulated by the FDA as food, not as drugs. The FDA does not approve these products before they are sold to consumers. The companies that make them are responsible for making sure they meet safety standards and do not violate the law. The FDA monitors adverse events reporting and can take action after complaints or injuries have been registered. There have been many recalls of dietary supplements for the inclusion of unapproved drugs that can cause serious health problems. In 2017, … [Read more...]
FDA Warns Companies Allegedly Selling Adulterated Dietary Supplements
The FDA has sent warning letters to companies that are allegedly selling adulterated dietary supplements. The supplements contain new dietary ingredients for which the FDA has not received the required premarket NDI notifications. Others contain unsafe food additives. And others are drugs that have not been approved, because they are intended for use in the care, mitigation treatment, or prevention of disease. Edit: The FDA has removed Glanbia from this list "On May 9, 2022, the FDA issued a Constituent Update (below) stating that Glanbia Performance Nutrition (Manufacturing), Inc. (Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. However, the FDA has since determined that Glanbia was incorrectly identified and does not sell the … [Read more...]
National Poison Prevention Week is 60; Drop in Child Poisoning Deaths
National Poison Prevention Week is 60 years old. There has been a dramatic drop in child poisoning deaths over the decades since this was started because of the efforts of the government and the Consumer Product Safety Commission. Alexander Hoehn-Saric, Chair of the U.S. Consumer Product Safety Commission said in a statement, "Decades of diligence and collaborative efforts have contributed to a dramatic decline in children being poisoned. Yet, progress is not guaranteed. Recent increases in fatalities demonstrate the need for continued vigilance and work to limit and eventually eliminate these preventable tragedies." National Poison Prevention Week started in 1962. Since then, this community, which includes the American Association of Poison Control Centers, consumer advocates, … [Read more...]
