FDA issues warnings to two companies for unapproved semaglutide, tirzepatide
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Key takeaways:
- The FDA sent warning letters to US Chem Labs and Synthetic Inc. for offering unapproved semaglutide and tirzepatide.
- The FDA said evidence showed companies intended for the drugs to be for human use.
The FDA has issued warning letters to two companies for offering unapproved and misbranded versions of semaglutide and tirzepatide on their websites, according to a press release.
On Feb. 7, the FDA sent letters to US Chem Labs and Synthetix Inc. for introducing unapproved and misbranded semaglutide (Ozempic/Wegovy, Novo Nordisk) and tirzepatide (Mounjaro/Zepbound, Eli Lilly) products into interstate commerce. According to the press release, both companies offered semaglutide and tirzepatide for sale on their websites “for research purposes.” However, the FDA stated in its letters to both companies that the claims made about the drugs on their respective websites suggest the products are intended to be drugs for human use.
In the warning letter sent to US Chem Labs, the company’s description of semaglutide claims the agent can improve glycemic control for people with type 2 diabetes, reduce the risks for stroke and myocardial infarction and that it is “quickly becoming famous for weight loss.” For tirzepatide, the website discusses numerous benefits, including improved glycemic control, weight loss, delayed or prevented need for insulin and improved quality of life, according to the FDA.
US Chem Labs was also cited for offering the peptide thymalin for both adults and children. According to the warning letter, the company claimed thymalin can treat various conditions, including immunosuppression after chemotherapy for people with cancer.
In the letter to Synthetix Inc., doing business as Helix Chemical Supply, the FDA cited evidence from the company’s website where it describes semaglutide as being able to lower glucose levels, enhance insulin secretion, improve heart, liver and lung function and slow or prevent the effects of Alzheimer’s disease. For tirzepatide, the FDA cited the company’s description of the standard dosing schedule, which is identical to the standard schedule for Mounjaro.
In both letters, the FDA stated the products being offered are not generally recognized as “safe and effective” and cannot be legally introduced into interstate commerce without approval from the FDA. Additionally, the FDA described the agents as misbranded as their labeling does not include “adequate directions for their intended use.” Both companies were directed to notify the FDA in writing within 15 working days of receiving the letter of the steps they will be taking to address the violations.
The warning letters come shortly after the FDA issued warnings to people with diabetes and obesity about the use of counterfeit medications. As Healio previously reported, the FDA issued a warning in December 2023 that counterfeit semaglutide was circulating in the U.S. drug supply chain. In January 2024, Lilly issued its own warning in a public letter that people should avoid using counterfeit or compounded tirzepatide medications.
References:
- Warning Letter – Synthetix Inc. DBA Helix Chemical Supply MARCS-CMS 668918. Available at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synthetix-inc-dba-helix-chemical-supply-668918-02072024. Published Feb. 7, 2024. Accessed Feb. 14, 2024.
- Warning Letter – US Chem Labs MARCS-CMS 669074. Available at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-chem-labs-669074-02072024. Published Feb. 7, 2024. Accessed Feb. 14, 2024.
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