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WARNING LETTER

Summit Research Peptides MARCS-CMS 695607 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Summit Research Peptides

1678 Montgomery Hwy, Ste 104-285
Hoover, AL 35216
United States

support@summitpeptides.shop
info@summitpeptides.shop
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

December 10, 2024

RE: 695607

Dear Summit Research Peptides:

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).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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