December 10, 2023

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...]

Dietary Supplement Salesman Sentenced For Anabolic Steroid Distribution

A dietary supplement salesman has been sentenced for conspiring to distribute anabolic steroids, according to a notice from the U.S. Justice Department. The salesman, James Boccuzzi, director of sales for the company, led sales for a sports and dietary supplement company called Blackstone Labs LLC, that was based in Boca Raton, Florida. A jury convicted him in December 2021 of conspiracy to defraud the FDA and conspiracy to distribute anabolic steroids. He was sentenced to 51 months by U.S. District Judge William P. Dimitrouleas of the Southern District of Florida. Boccuzzi and co-conspirators conspired to defraud the FDA and to illegally manufacture and distribute anabolic steroids that were controlled substances under the Designed Anabolic Steroid Control Act. Evidence at trail … [Read more...]

FDA Allows Qualified Health Claim For Magnesium and Blood Pressure

The FDA is allowing a qualified health claim for magnesium and blood pressure, that it will not object to the use of certain health claims regarding the consumption of that mineral and a reduced risk of high blood pressure. The claim will be allowed if it is "appropriately worded" to avoid misleading consumers, and if other factors for the use of this claim are met. A petition was submitted on behalf of The Center for Magnesium Education and Research, LLC. It requested that the FDA authorize a health claim about the relationship between the consumption of magnesium and the reduced risk of high blood pressure. A health claim iterates the relationship between a substance and a disease or health-related condition. The petition was reviewed, along with other evidence related to the … [Read more...]

FDA Warns Against Black Oxygen Organics Fulvic Care Powder and Tablets

The FDA is warning consumers not to take Black Oxygen Organics Fulvic Care Powder and Tablets dietary supplements because they may contain elevated levels of lead and arsenic. Immediately stop using the product and do not let other household members or pets to use them. These products were sold online at the company's website. Black Oxygen Organics Fulvic Care Powder and Tablets were sampled at the U.S.-Canadian border, where the high levels of the heavy metals were found. The FDA detained the shipment and put the product under Import Alert 99-42. You can see pictures of product labels at the FDA web site. More shipments of the product were detained after September 14, 2021, but the firm released those products into commerce without the FDA's knowledge when they should have been … [Read more...]

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