WARNING LETTER
Xcel Research LLC
MARCS-CMS 694608 —
December 10, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Andrew Pierce
Xcel Research LLC
1309 Coffeen Ave., Suite 12238
Sheridan
,
WY
82801
United States
Support@XcelPeptides.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
December 10, 2024
RE: 694608
Dear Andrew Pierce:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.xcelpeptides.com in October 2024 and has observed that your website offers various products such as “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” for sale in the United States. As described below, your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” 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, “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE,” evidence obtained from your website establishes 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 website that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:
“RETA” (Retatrutide)
On your webpage https://www.xcelpeptides.com/product/reta/:
• “Retatrutide, a triple agonist peptide, interacts with glucagon, GIP, and GLP-1 receptors. In clinical trials, it exhibits potential for weight management by regulating appetite and metabolism in research test subjects.”
• “Enhanced Insulin Sensitivity . . . By enhancing insulin sensitivity, retatrutide peptide helps test subjects maintain stable blood glucose levels and reduces the risk of developing metabolic disorders associated with insulin resistance.”
• “Cardiovascular Protection . . . [R]etatrutide peptide has been shown to improve endothelial function, reduce arterial stiffness, and lower blood pressure, thus reducing the risk of cardiovascular diseases such as hypertension and atherosclerosis.”
“CagriLean” (Cagrilintide and Semaglutide)
On your webpage https://www.xcelpeptides.com/product/cagrilean/:
• “Cagrilintide and semaglutide blend that aids test subjects in managing weight and improving blood sugar levels. This peptide combination helps research subjects feel fuller for longer, curbing their appetite and enhancing metabolic function.”
• “Understanding Cagrilintide and Semaglutide . . . Cagrilintide is a synthetic peptide known for its ability to regulate appetite. It mimics the natural hormone amylin, which plays a crucial role in controlling hunger and food intake. On the other hand, Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It has been extensively researched for its effects on glucose regulation and appetite suppression.”
• “Enhanced Glucose Regulation . . . CagriLean helps maintain stable blood glucose levels, reducing the risk of glucose spikes and crashes. This can be instrumental in experiments focusing on insulin sensitivity, glucose metabolism, and the development of diabetes treatments.”
“CAGRILINTIDE”
On your webpage https://www.xcelpeptides.com/product/cagrilintide/:
• “Enhanced Glucose Control . . . By influencing the release of insulin and other hormones involved in glucose metabolism, it may help stabilize blood sugar levels. This effect could be beneficial for research test subjects with conditions such as diabetes or insulin resistance.”
• “Improved Lipid Profile: Research suggests that Cagrilintide may also have favorable effects on lipid metabolism, leading to improvements in lipid profiles. By influencing the breakdown and utilization of fats, it may help lower levels of triglycerides and LDL cholesterol while increasing HDL cholesterol levels.”
• “Cagrilintide exhibits a wide range of potential health benefits for research test subjects, spanning appetite regulation, glucose control, weight management, lipid metabolism, inflammation, cardiometabolic protection, neuroprotection, and the convenience of long-acting formulation.”
“MAZDUTIDE”
On your webpage https://www.xcelpeptides.com/product/mazdutide/:
• “Mazdutide. . .[is] designed to mimic the actions of a hormone called glucagon-like peptide-1 (GLP-1). It offers numerous benefits in research subjects, such as improving blood sugar control by stimulating insulin secretion and reducing appetite. Additionally, it aids in weight management and may enhance cardiovascular health by lowering blood pressure and improving cholesterol levels.”
• “Cardiovascular Health: Mazdutide exhibits cardioprotective effects, which could be advantageous for research test subjects at risk of cardiovascular diseases. GLP-1 receptor activation has been linked to improvements in cardiovascular function, such as reducing blood pressure and improving lipid profiles.”
“SEMA” (Semaglutide)
On your webpage https://www.xcelpeptides.com/product/sema/:
• “Regulation of Blood Sugar Levels: Sema exhibits potent glucose-lowering effects by stimulating insulin secretion and inhibiting glucagon release, two crucial mechanisms in maintaining blood sugar balance.”
• “Weight Loss and Appetite Suppression: . . . By acting on specific receptors in the brain, this peptide promotes satiety and reduces food intake, leading to decreased body weight and fat mass.”
• “Neuroprotective Potential: Emerging evidence suggests that semaglutide peptide may possess neuroprotective properties, offering potential benefits in neurodegenerative diseases such as Alzheimer’s disease.”
“SURVODUTIDE”
On your webpage https://www.xcelpeptides.com/product/survodutide/:
• “Survodutide. . .belongs to a class of drugs known as dual agonists, meaning it targets two different types of receptors in the body: the glucagon receptor and the glucagon-like peptide-1 (GLP-1) receptor. These receptors play crucial roles in regulating various bodily functions, including metabolism, appetite, and blood sugar levels.”
• “Health Benefits of Survodutide . . . Improved Blood Sugar Control[.] One of the most significant benefits of survodutide is its ability to improve blood sugar control in research lab subjects . . .. [I]t can help regulate blood glucose levels more effectively than targeting either receptor alone. In research subjects, this dual action has shown promise in stabilizing blood sugar levels, which is crucial for managing conditions like diabetes."
“SERMORELIN”
On your webpage https://www.xcelpeptides.com/product/sermorelin/:
• “Sermorelin, a peptide studied in clinical trials, is believed to enhance the release of growth hormone in subjects. This heightened growth hormone production is associated with potential benefits, including improved metabolism and the facilitation of weight loss.”
• “Enhanced Muscle Growth and Repair[.] One of the primary benefits observed in test subjects administered with sermorelin is enhanced muscle growth and repair.”
• “Improved Metabolism and Fat Loss[.] Another notable benefit of sermorelin is its potential to improve metabolism and aid in fat loss.”
Your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN” 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 actions 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
Content current as of:
12/17/2024
Regulated Product(s)
Drugs