FDA Roundup: February 13, 2024

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Feb 13, 2024, 12:27 ET

SILVER SPRING, Md., Feb. 13, 2024 /PRNewswire/ -- 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 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.
On Monday, Covetrus North America LLC, a company based in Dublin, Ohio, which sells veterinary products to customers across the United States, pled guilty to causing the introduction and delivery of misbranded veterinary prescription drugs into interstate commerce. As part of the agreement, Covetrus will pay over $23 million in criminal fines and forfeitures.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration