FDA Warning Letter on misbranded and unapproved Drugs

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

On February 7, 2024, the FDA published a new Warning Letter addressing the company US Chem Labs from the United States. The products concerned are the new drugs "Semaglutide", "Tirzepatide" and "Thymalin", which have not been approved by the FDA and have been marketed or supplied for distribution in violation of FDA regulations. In addition, these products are misbranded ("research chemicals only"; "not for human consumption"). According to the FDA definition of drugs and also according to information on the website, they are intended to prevent, treat or cure disease and/or affect the structure or function of the body. While Semaglutide and Tirzepatide are used to treat type 2 diabetes, many patients have recently turned to these drugs for weight loss instead. Thymalin, on the other hand, biologically stimulates the thymus to produce more peptides that help regulate the immune and endocrine systems. The thymus gland has the task of producing T lymphocytes or T cells.

Unapproved new drugs

In summary, the products "semaglutide", "tirzepatide" and "thymalin" are not generally recognized as safe and effective for the uses described above and are therefore "new drugs for human use". Subject to certain exceptions not applicable here, new drugs may not be legally introduced or supplied into commerce without an FDA-approved application, which has not been done for these products. In addition, the FDA is particularly concerned that for the "Thymalin" product marketed for use in children. The use of untested drugs may have unpredictable and unintended consequences, particularly in vulnerable populations such as children and infants, who may be at greater risk for adverse effects associated with certain drugs due to children's varying ability to absorb, metabolize, distribute, or excrete such drugs or their metabolites.

Misbranded drugs

The products "Semaglutide", "Tirzepatide" and "Thymalin" are also misbranded in that their labeling does not provide adequate directions for the intended use(s). Adequate directions for use" means directions that would enable a non-specialist to use a medicinal product safely and for its intended purpose(s). Prescription-only medicinal products include those which, because of their toxicity or other potentially harmful effects or because of the way they are used or the accompanying measures required for their use, can only be used safely under the supervision of a legally authorized medical specialist. The products "Semaglutide", "Tirzepatide" and "Thymalin" are indicated for conditions that cannot be diagnosed and treated by a non-professional. Therefore, adequate instructions cannot be written so that a layperson can safely use the products for their intended purposes. In addition, the products "Semaglutide", "Tirzepatide" and "Thymalin" are also prescription-only medicinal products in view of their toxicity or potential for adverse effects, their methods of administration or the accompanying measures required for their use.

More detailed information can also be found in the FDA's warning letter to US Chem Labs.