December 11, 2019

Search Results for: supplements

Life Rising Dietary Supplements Seized by U.S. Marshals

U.S. Marshals seized more than 300,000 containers of dietary supplements from Life Rising Corporation in June 2019 at the request of the FDA. The seized goods included tablets, capsules, and teas. The brand names for some of the 500 products are Life Rising, Holicare, or HopeStream. The U.S. District Court for the Northern District of Illinois found that there was probable cause that "the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements," according to the FDA news release. The FDA issued an Administrative Detention Order in May 2019 to prevent these products from reaching consumers until they could be seized based on these violations. Melinda K. … [Read more...]

Life Rising Supplements Recalled For Possible Lead Contamination

Life Rising Corporation of Willowbrook, Illinois, is recalling  Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because they may cantina excessive levels of lead. When consumed, lead can cause serious health problems, including damage to the nervous system and internal organs. Symptoms of acute, or short term, lead poisoning include abdominal pain, nausea, muscle weakness, vomiting, diarrhea, weight loss, and bloody urine. The long term consequences of lead poisoning can include learning difficulties, hearing loss, lower IQ, and developmental delay. Children are especially vulnerable to lead poisoning. These recalled dietary supplements were sold mostly in the Chicago area at HoliCare clinics, … [Read more...]

FDA Goes After Dietary Supplements That Claim Alzheimer’s Treatment

The FDA is taking action against 17 companies for illegally selling dietary supplement products that claim to treat or cure Alzheimer's disease. The agency posted 12 warning letters and 5 online advisory letters to those corporations. The companies are illegally selling more than 58 products, many sold as dietary supplements, that are unapproved new drugs or misbranded drugs. These products have not been reviewed by the FDA and are not proven safe and effective to treat these diseases and health conditions. In fact, these products could be unsafe and could prevent a patient from seeking proper treatment. FDA Commissioner Dr. Scott Gottlieb said in a statement, "Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical … [Read more...]

Supplement Makers Warned by FDA About Tianeptine in Dietary Supplements

The FDA is warning two companies for illegal marketing of dietary supplements that contain tianeptine. One of the warning letters was sent to MA Labs LLC, for Vicaine, and the other was sent to Jack B Goods Outlet Store, for Tianaa Red, Tianaa White, and Tianaa Green. Tianeptine has caused serious adverse events, according to that agency. Tianeptine is illegally used to treat opioid use disorder, and pain and anxiety. It is not a vitamin, mineral, herb, among acid dietary substance; or a concentrate, metabolite, constituent, extract, or combination of those substances. Dr. Scott Gottlieb, FDA Commissioner, said in a statement, "The bottom line is this: we’ve seen growing instances where profiteers are pushing potentially dangerous compounds – often with unproven drug claims and … [Read more...]

Permanent Injunction Issued Against Dietary Supplements Containing Undisclosed Drugs

The U.S. District Court for the District of New Jersey has entered an order of permanent injunction against S. Hackett Marketing LLC doing business as Just Enhance. This injunction requires the defendants to cease the distribution of their products until they take remedial measures and comply with the Federal Food, Drug, and Cosmetic Act. The notice states that the defendants violated the Act by selling unapproved drugs and misbranded drugs to consumer on more than 100 different websites. The complaint states that the label on these products claimed, without FDA approval or any clinical studies demonstrating safety and effectiveness, that they could treat or provident serious conditions. Some of those conditions included impotence and prostatitis. Testing at the FDA laboratory … [Read more...]

Two Recalls: One for Chicken Produced Without Inspection; Another for Allergens in Supplements

Two recalls have been issued by the USDA and FDA for two different products. Halal chicken has been recalled for lack of inspection, and dietary supplements are recalled for undeclared allergens. No illnesses or allergic reactions have been reported to date in either recall. The first recall is for Afandina Halal's raw poultry products that were produced without the benefit of several inspection. These raw chicken items were produced and packaged from May 14 through June 22, 2018. They include 40-pound bulk boxes containing “Afandina, Halal Wholesale Chicken, Boneless Leg Meat,” 40-pound bulk boxes with “Afandina, Halal Chicken, Whole Chicken Legs,” and 40-pound bulk boxes with “Afandina, Halal Chicken, Chicken Cutlets.” These products have the establishment number "P-51183" inside the … [Read more...]

Two Manufacturers Recall Kratom Supplements for Possible Salmonella

Two manufacturers are recalling kratom-containing dietary supplements for possible Salmonella contamination. Illness have been reported tied to these recalled products. Badger Botanicals of Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements that were sold directly to consumers through the company website from January 1, 2018 to April 12, 2018 because it has the potential to be contaminated with Salmonella. One potential illness has been reported in connection with this issue. There is a multistate Salmonella outbreak linked to some kratom containing products in the U.S. right now. At least 132 people are sick in this outbreak as of April 5, 2018, according to the FDA. We don't know whether or not the illness reported in this recall is … [Read more...]

Nutrizone Expands Recall of Kratom Dietary Supplements to Include All Products for Possible Salmonella Contamination

Nutrizone is expanding its recall of various lots of multiple dietary products for possible Salmonella contamination again.  The recall is being expanded to include all lots sold. No illnesses have been reported to date in connection with these specific products, but there is a multistate Salmonella outbreak linked to kratom-containing products at this time. At least 132 people in 38 states have been infected with one of four strains of Salmonella bacteria. All lot numbers, all package sizes, and all types of packaging of the following products are recalled: Cali Green Malay, Cali Maeng Da, Cali Thai, Nirvanio Bali, Nirvanio Green Malay, Nirvano Maeng Da, Nirvano Special Reserve, Pain Out Green Malay, Pain Out Maeng Da, and Pain Out Thai. These products were sold in Florida, California, … [Read more...]

Pain Out Dietary Supplements Recalled for Possible Salmonella

NutriZone of Houston, Texas is recalling four different kratom-containing dietary supplements because they may be contaminated with Salmonella bacteria. No illnesses have been reported to date in connection with this problem. These kratom products were sold in Pennsylvania, Oklahoma, Washington, Missouri, Florida, Mississippi, California and Texas at the retail level. The products include Pain Out Maeng Da in 36 capsule pouches. The lot number is 10957. Also recalled is Pain Out Thai in 108 capsule bottles. That lot number is 10960-D. Pain Out Malay in 324 capsule bottles is also recalled, with lot number 10958-I. And finally, Nirvanio Green Malay in 25 capsule bottles, with lot number 10958-C is recalled. Lot numbers are found on the packaging near the Nutrition Facts panel. Routine … [Read more...]

Consent Decree Issued Against MyNicNaxs, Maker of Dietary Supplements

A federal court ordered a Florida-based company called MyNicNaxs to stop selling drugs and dietary supplements until it complies with the Federal Food, Drug, and Cosmetic Act and other requirements. The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction against MyNicNaxs of Deltona Florida. The company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers online through their websites. Some of these products tested positive for undeclared active pharmaceutical ingredients. Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research said in a statement, "Marketing products with undeclared active pharmaceutical … [Read more...]

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