The FDA is warning consumers not to buy or use Neptune's Fix, a product that is marketed for pain relief, to improve brain function, and treat anxiety, depression, and opioid use disorder. The government has received reports of serious complications after the use of this product, including seizures and loss of consciousness. The product contains tianeptine, which is a substance that is not approved by the FDA for any medical use. Tianeptine is considered an alternate to fentanyl and oxycodone. While some companies in this country are planning to seek FDA approval for this drug, that has not happened. According to Consumer Reports, tianeptine-related calls to poison controls centers have "skyrocketed" since 2015. At least four people in the United States have died after using the … [Read more...]
Consent Decree Against Evig Dietary Supplement Manufacturer
A consent decree of permanent injunction has been entered against Evig LLC, a dietary supplement manufacturer and distributor, along with the company's CEO, and Premium Production LLC and its manager, according to the FDA. These companies produce and market Balance of Nature Products, with false label claims. Those corporations are located in St. George, Utah. The U.S. District Court for the District of Utah, Central Division entered the consent decrees. The FDA has not approved the Balance of Nature products for any use. The company has made claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19. And Evig LLC violated current good manufacturing practice (CGMP) … [Read more...]
Preterm Infant Dies After Receiving Evivo with MCT Oil Probiotic
A preterm infant has died after receiving Evivo with MCT Oil probiotic in the hospital. That dietary supplement, produced by Infinant Health, is formulated to contain the live bacterium Bifidobacterium longum subsp. infantis, according to the FDA. The infant developed sepsis caused by that bacterium. The FDA is investigating this death. Genomic sequencing data found that the bacteria that caused sepsis in the infant was a genetic match to the bacteria in the probiotic. The FDA is now warning that preterm infants who are given these dietary supplements are "at risk of invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics." Medical literature reports state that microorganisms in probiotics have caused bacteremia or fungemia, sometimes with severe … [Read more...]
Permanent Injunction Issued Against Dietary Supplement Confidence USA
An order of permanent injunction has been entered against Confidence USA Inc. of Long Island, New York, and the company's president Helen Chian and general manager and founder Jim Chao by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York. The order was entered until the company "comes into compliance with federal supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements." The defendants must cease manufacturing, holding, or distributing dietary supplements until the FDA tells them they can resume operations. The company has made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. … [Read more...]
Dietary Supplement Executive Sentenced For Fraudulent Sales
A dietary supplement executive has been sentenced to prison in a Texas federal court for his role in fraudulently seeing popular workout supplements, according to the U.S. Department of Justice. Former S.K. Laboratories Vice President Sitesh Patel of Irvine, California, was sentenced to 41 months imprisonment and one year of supervised release by U.S. District Juge Sam A. Lindsay. According to documents that were filed intros case, Patel "Patel played a key role in developing and manufacturing the popular workout and weight loss supplements known as Jack3d and OxyElite Pro, which were distributed by Dallas-based USPlabs." Patel and several co-defendants admitted that they imported substances "with false and misleading labeling to avoid law enforcement and regulatory agency … [Read more...]
OxyElite Pro Dietary Supplement Executives Sentenced in Fraud Scheme
A federal court in Texas has sentenced two former OxyElite Pro dietary supplement executives to prison and ordered two companies to pay $10.7 million in criminal forfeiture for fraudulently selfing popular workout supplements called Jack3d and OxyElite Pro, according to the United States Department of Justice. U.S. District Judge Sam A. Lindsay presided. Former USPlabs CEO Jacobo Geissler was sentenced to 60 months, and former USPLabs president Jonathan Doyle was sentenced to 24 months. All of the defendants were charged in a 2015 indictment returned by a federal grand jury in the Northern District of Texas. U.S. Attorney for the Northern District of Texas, Erin Nealy Cox, said in a statement, "Dietary supplement companies cannot be allowed to deceive their consumers and hide the … [Read more...]
FDA Alerts Consumers to Dangers of Cesium Salts in Supplements
The FDA Is issuing a public health alert about dietary supplements that contain cesium salts, primarily cesium chloride. This ingredient has significant safety risks, including heart toxicity and potential death. The FDA is also alerting health care professionals about the risks of cesium salts, which are sometimes promoted as alternative treatments for cancer. Cesium salts have never been proven to be safe and effective to treat cancer or for any other use. While only a few dietary supplements on the market contain this ingredient, consumers should not purchase those products. According to the alert, there have been"multiple clinical case reports and non-clinical studies show significant safety concerns related to the use of such products, including potentially fatal cardiac … [Read more...]
Consent Decree Against Biogenyx and Basic Reset For FD&C Act Violations
A federal court has ordered two Tennessee-based companies to stop distributing drugs, dietary supplements, and devices until the companies comply with the Federal Food, Drug, and Cosmetic Act (FD&C). The companies are Biogenyx and Basic Reset. The FDA has not approved these drugs or devices "for any use, despite the companies’ claims that these products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain." In addition, those companies have unlawfully distributed dietary supplements that are adulterated and misbranded, according to the decree. During inspections at the facilities, FDA inspectors found numerous violations of the Current Good Manufacturing Practices … [Read more...]
FDA Warns Against Miracle or Master Mineral Solution; Illnesses Reported
The FDA has issued a warning to consumers to avoid Miracle or Master Mineral Solution, since they have received many reports that these products have made consumers sick. The government first warned consumers about these products in 2010, but they are still being promoted on social media and sold online by independent outlets. These products are marketed under various names, including Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, and Water Purification Solution (WPS). When these products are mixed according to package directions, they become a chemical that is used as bleach. In addition, some of the distributors are making false and dangerous claims that Miracle Mineral Supplement, when mixed with citric acid, acts as an … [Read more...]
Permanent Injunction Closes Dietary Supplement Makers
The U.S. District Court for the District of Colorado has entered a permanent injunction against EonNutra LLC, two related companies, CDSM LLC and HABW LLC, and their owner, to prevent the distribution of "adulterated and misbranded dietary supplements and unapproved and misbranded drugs." The Department alleges that the defendants, who sell about 150 dietary supplement products, violated the Federal Food, Drug, and Cosmetic Act. Several of those products were labeled as dietary supplements, but were marketed as drugs. The company claimed that the product could help treat or prevent diseases such as "heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders." According to the complaint, the defendants offered these claims to the public without … [Read more...]
