Summit Research Peptides — FDA Warning Letter (December 10, 2024)

Summary

Company

Summit Research Peptides

Letter number

#695607

Issue date

December 10, 2024

Subject

Unapproved New Drugs/Misbranded

Word for word, from the letter of December 10, 2024

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://summitpeptides.shop in October 2024 and has observed that your website offers “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products for sale in the United States. We have also reviewed your social media website at https://www.facebook.com/summitpeptides/. Your social media website directs consumers to your https://summitpeptides.shop website to purchase your products. As described below, your “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Despite statements on your product labeling marketing your products as “RESEARCH USE ONLY” and “INTENDED AS A RESEARCH CHEMICAL ONLY,” evidence obtained from your websites establish that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your websites that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:

From your “Semagultide” (or “Sema”) product webpage https://summitpeptides.shop/products/sema-10-pack?variant=45101962887394:• “Overview: Sema is a GLP-1 analog with therapeutic applications in type 2 diabetes and obesity. It enhances insulin secretion and reduces appetite, leading to improved glycemic control and weight loss.”• “Product Features: o GLP-1 analog simulating human incretin activity o Enhances insulin secretion and beta cell function o Delays gastric emptying, reducing appetite o Supports weight management in obesity o Exhibits cardioprotective and neuroprotective potential”

From your “Retatrutide” (or “Reta”) product website https://summitpeptides.shop/products/reta?variant=45843937525986:• “Overview: Reta is an experimental tritagonist drug targeting three hormone receptors: GLP-1, GIP, and glucagon. It is designed to mimic these hormones' effects, such as enhancing satiety, regulating blood sugar, and suppressing appetite.”• “Product Features: o Tritagonist: Interacts with GLP-1, GIP, and glucagon receptors. o Regulates appetite and blood sugar levels. o Administered via specific receptors in the brain and gut.”• “Conclusion: Reta presents a promising approach for obesity and diabetes treatment, offering a novel mechanism of action through a triple-receptor agonist profile. It’s a significant development in the search for more effective treatments for these conditions.”

On your social media website at https://www.facebook.com/summitpeptides/:• May 18, 2024 post: “Unlock Maximum Health Benefits with Cagrilintide and Semaglutide . . . designed to help you achieve your health goals more effectively than ever before! Enhanced Weight Loss: Achieve superior weight reduction with the synergistic effects of Cagrilintide and Semaglutide. Experience greater weight loss results and take control of your journey to a healthier you. Optimized Cardiovascular Health: Support your heart health with this powerful combination. Promote better cardiovascular health and ensure your heart remains strong and healthy. Improved Glucose Management: Maintain stable blood sugar levels and achieve effective glucose control with the combined benefits of Cagrilintide and Semaglutide, enhancing your overall metabolic health . . . Achieve Your Weight Loss Goals Faster with Cagrilintide & Semaglutide”

From your “Tirzepatide” (or “Tirz”) product website https://summitpeptides.shop/products/tirz?_pos=1&_sid=39f4021bd&_ss=r• “Overview: Tirzepatide is a cutting-edge synthetic derivative of the Glucagon-Like Peptide-1 (GLP-1), designed specifically for the scientific community to advance research in metabolic disorders and diabetes management. With its unique structure and mode of action, Tirz represents a promising frontier for investigating new therapeutic strategies.”• “Research Applications: Tirz is extensively utilized in preclinical studies to explore its potential in: o Enhancing insulin secretion o Regulating blood sugar levels o Investigating weight management pathways o Exploring cardiovascular benefits.”

From your “Mazdutide” product website https://summitpeptides.shop/collections/full-catalog/products/mazdutide• “Mazdutide is an investigational peptide with a novel dual-action mechanism, designed to mimic and enhance the biological activities of certain endogenous hormones. It is at the forefront of research in metabolic disorders and has shown promising results in early studies related to weight management and glucose regulation.”• “Mazdutide is primarily investigated for its potential in: o Understanding and enhancing wight loss mechanisms o Improving glucose homeostasis in diabetic models o Studying hormone receptor interactions and signaling pathways o Exploring its effects on metabolic rate and energy expenditure

Your “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024

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