July 3, 2022

Search Results for: supplements

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 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...]

Rae Wellness Dietary Supplements Recalled For Child Resistant Packaging Failure

Two Rae Wellness dietary supplements are being recalled due to failure to meet the child resistant packaging requirement. This poses a risk of poisoning to children. The recalled products are Rae Prenatal Capsules and Rae Immunity Capsules. The recalling firm is Rae Wellness of Minneapolis, Minnesota. These products were manufactured in the United States. The products are dietary supplements that contain iron. Any product that has iron must be in child resistant packaging per the Poison Prevention Packaging Act. No illnesses or adverse events have been reported to date. The Rae Wellness dietary supplements were sold at Target stores nationwide and online at Target.com, ThriveMarket.com, Amazon, FabFitFun.com, and StandardDose.com from September 2019 through February 2022 for the … [Read more...]

Consent Decree Against Salud Natural Entrepreneur Supplements

A consent decree has been issued against Salud Natural Entrepreneur, Inc. (Salud) for allegedly distributing adulterated and misbranded dietary supplements and unapproved new drugs. The company allegedly claimed that theoe products would cure, mitigate, treat, or prevent diseases such as cancer, diabetes, heart disease, and high blood pressure. The decree was filed by the Department of Justice in the Northern District of Illinois on March 3, 2022 on behalf of the FDA. The decree also alleges that Salud did not comply with current Good Manufacturing practices regulations that are designed to help ensure the safety of nutritional supplements. And also, the decree alleges that on one occasion Salud used ingredients that had tend positive for Salmonella bacteria in manufacturing a … [Read more...]

Blackstone Labs Conspired to Sell Unlawful Dietary Supplements

Blackstone Labs and two of its executives pleaded guilty to conspiring to sell illegal anabolic steroid and unlawful dietary supplements, according to the U.S. Justice Department. According to court documents, on November 17, 2021, the executives, Phillip Braun and Aaron Singerman, pleaded guilty to distributing controlled substances and to selling unapproved new drugs.in violation of FDA statutes through their company, which was located in Boca Raton, Florida. The defendants admitted that, from 2012 through 2017, they conspired to sell products that were unapproved new drugs and/or illegal controlled substances, while they falsely characterized their products as safe and legal dietary supplements under the Designer Anabolic Steroid Control Act. The products were also falsely … [Read more...]

Nutracap Dietary Supplements Recalled For Undeclared Allergens

Nutracap dietary supplements, including the brands Boba Origin, Etedream, RAW, Steel, and Vital Force, are being recalled for the allergens wheat, milk, soy, and coconut that are not declared on the label. Anyone who is allergic to those ingredients, including people who have lactose intolerance or celiac disease, could have a serious reaction if they eat them. No illnesses or allergic reactions have been reported by the company to date. These Nutracap dietary supplements were shipped to Alabama, California, Florida, and Texas from June 4, 2020 though October 1, 2021. During an FDA inspection on November 4, 2021, the firm was notified that their labels did not disclose the presence of these allergens on some of their products. You can see pictures of the recalled products at the FDA … [Read more...]

Bea Lydecker Living Free Supplements Recalled For Allergen

Bea Lydecker's Naturals of Oregon City, Oregon is recalling six Bea Lydecker Living Free supplements products because they contain soy, one of the major food allergens, that is not declared on the label. Anyone who is allergic to soy could have a serious allergic reaction if they consume these products. No allergic reactions have been reported to the company to date in connection with this issue. These dietary supplements were distributed to retailers, wholesalers, and practitioners nationwide. They were also sold from the company's website between June 2019 and June 17, 2021. These are the recalled products: Living Free Adult Extra (vitamins), 100 capsules per bottle. Living Free Adult Extra (vitamins), 500 capsules per bottle. Living Free Heart/Blood Vessel, 100 capsules … [Read more...]

FDA Warns Companies For Selling Dietary Supplements With False Claims

The FDA has warned 10 companies for selling dietary supplements with false claims, sending them warning letters. These supplements "claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act)." The warning letters were issued to: Enlifta LLC; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc. Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA's Center for Food Safety and Applied Nutrition, said in a statement, "Dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health … [Read more...]

FDA Says Some Weight Loss, Other Supplements May Be Dangerous

The FDA has released a consumer update stating that weight loss products and other supplements, including male enhancement products, that are sold online or in stores may be dangerous because they may be illegal. Some of these dietary supplements can be made with potentially dangerous ingredients that are not listed on the label. Over the past 10 years, the FDA has waned consumers that some products that are sold over the counter contain active hidden ingredients. This is especially the case for products that are marketed for weight loss, pain relief, body building, sleep aids, and male enhancement. Some of these products are actually drugs and are falsely represented as being dietary supplements. FDA has also found products that are marketed as supplements that claim to treat or … [Read more...]

FDA Finds Bitter Orange Supplements Can Contain Unapproved Drugs

The FDA has released a study that finds some bitter orange dietary supplements can contain unapproved drugs. This supplement is sold as a sports performance supplement and weight management supplement. It became popular after Ephedra products, a type of amphetamine, were banned from the U.S. after it was linked to heart attacks, strokes, seizures, and sudden deaths. But as Consumer Reports points out, the government agency hasn't begun enforcement action against the companies that make these products, nor has it warned consumers about them. Manufacturers claim that bitter orange supplements increase energy and suppress appetite. The bitter orange supplements can contain synephrine, an amine, which can cause adverse cardiovascular events, especially when taken with caffeine. For … [Read more...]

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