Tuesday, February 13, 2024

 

  • From FDA Roundup dated 2/13/2024
  • Today, the FDA posted warning letters to US Chem Labs and Synthetix Inc. doing business as Helix Chemical Supply for introducing unapproved and misbranded semaglutide and tirzepatide products into interstate commerce. 

    US Chem Labs offers for sale semaglutide and tirzepatide “for research purposes.”  However, the products are accompanied by claims such as weight loss, reducing the risk of stroke, heart attack, or heart disease. In addition, the firm offers a product called “thymalin” (not related to semaglutide or tirzepatide) for both adults and children, for treatment of various conditions, such as immunosuppression after chemotherapy in cancer patients.

    Helix Chemical Supply also offers semaglutide and tirzepatide for sale for “research purposes.” However, the products include claims such as treatment of Alzheimer’s disease, lowering blood sugar, or enhancing insulin secretion. 

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