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FDA Press Releases·

FDA Roundup: February 13, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 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 c...