The agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns. Under the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements, and generally require preapproval from the FDA. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. The agency has previously expressed concern about several of these ingredients for reasons including, for example, the potential adverse effects of higenamine on the cardiovascular system. The dietary supplements sold by the companies listed above contain one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine. Nutritional Sales and Customer Service LLC.New York Nutrition Company (American Metabolix).Exclusive Nutrition Products, LLC (Black Dragon Labs).Warning letters were sent to the following companies: These products could potentially harm consumers. Some of the identified dietary supplements also are drugs, despite lacking approval, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Food and Drug Administration (FDA) posted warning letters to multiple companies for selling adulterated dietary supplements that contain, in some cases, new dietary ingredients (NDIs) for which the FDA has not received the required premarket NDI notifications and, in others, unsafe food additives. The FDA regrets the confusion this error has caused. As a result, the Warning Letter the FDA issued to Glanbia has been retracted and the FDA is continuing its investigation to determine the responsible firm and reissue the warning letter. Glanbia discovered this error and immediately notified the FDA. The error occurred because the website on which the products Uplift Max and Shred Her Max are sold incorrectly stated that the site was the property of one of Glanbia’s subsidiaries, Optimum Nutrition. However, the FDA has since determined that Glanbia was incorrectly identified and does not sell the products Uplift Max and Shred Her Max, which were cited in the FDA Warning Letter sent to the company on May 4, 2022. (Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. The codes are official episode numbers used by the network.On May 9, 2022, the FDA issued a Constituent Update (below) stating that Glanbia Performance Nutrition (Manufacturing), Inc. The dates, days, and times listed are for their first appearance on the network. The episode list and air dates below are for Nickelodeon and Nicktoons in the United States. The series stars Jonny Gray, Jake Goodman, Saara Chaudry, Emilia McCarthy, Jean-Michel Le Gal, and Siobhan Murphy. Next-door neighbor Jill - called Howie from always asking “how?” - is Shred’s curious apprentice and pops in unexpectedly, usually through his window. Shred’s confident sister, Abby, enjoys teasing her brother but is always there for him when it counts. The roommates become buddies and make their way through trials of teen life, which they approach from opposite points of view. About The ShowĬelebrity snowboarder Max Asher recently moved to Colorado to train for the Winter Cup and lives with the family of whiz kid Alvin Ackerman - whom Max nicknames Shred. Five episodes remain unaired in the United States. After the first season, the show was moved to Nicktoons. The Canadian co-produced series lasted two seasons and 39 episodes. Max & Shred premiered on Nickelodeon in October 2014.
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