NuScience Peptides LLC
FDA issued a warning letter to NuScience Peptides LLC (Cornelius, NC), operated by Joseph and Ratsamy DeRosa, after a July 2026 website review found the company selling multiple unapproved injectable peptide drugs — including GLP-1/GLP-2/GLP-3 analogs, Survodutide, Mazdutide, PT-141 (Bremelanotide), Tesamorelin, and Bacteriostatic Water — without FDA-approved applications under FD&C Act section 505(a). The products' own marketing copy established intended human therapeutic use despite 'research use only' disclaimers, constituting unapproved new drug violations under sections 301(d) and 505(a). FDA warned that failure to correct violations could result in seizure and injunction, and required a written corrective response within 15 business days.
Flagged claims (13)
[R]esearch has indicated that ipamorelin can counteract glucocorticoid-induced reductions in bone formation, suggesting its potential in mitigating bone density loss associated with glucocorticoid therapy.
Tesamorelin, a growth hormone-releasing hormone (GHRH) analog, has been shown to significantly reduce visceral adipose tissue and improve liver health by decreasing liver fat and preventing fibrosis progression.
**Mechanism of cardiovascular benefit and weight loss** In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration.
Survodutide (BI 456906) is a dual agonist targeting both the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R), developed for laboratory research into obesity and type 2 diabetes metabolic pathways. Preclinical studies in rodent models have demonstrated its efficacy in promoting weight loss and improving glycemic control.
Beyond metabolic effects, tesamorelin has demonstrated the ability to reduce muscle fat and increase muscle area in clinical studies . . . [s]uch findings are particularly relevant for exploring interventions in muscle-wasting conditions.
Furthermore, research indicates that tesamorelin may enhance cognitive function, including improvements in executive function and verbal memory.
Mazdutide (IBI362), a dual agonist targeting both GLP-1 and glucagon receptors, has shown promising results in clinical trials for weight management and metabolic disorders. This mazdutide peptide has been extensively studied in humans, but preclinical research, particularly in rat models, remains limited.
PT-141, also known as bremelanotide, is a synthetic PT-141 peptide classified as a non-selective agonist of melanocortin receptors, with primary activity at MC3R and MC4R. This research peptide has been widely examined in preclinical models to better understand melanocortin-mediated signaling pathways involved in sexual behavior and neuroendocrine regulation.
In conclusion, survodutide's dual GCGR/GLP-1R agonism offers a multifaceted approach to treating metabolic disorders. Its efficacy in preclinical models supports further investigation and development as a subject of investigation for obesity and metabolic disorder research.
GLP-2 Tirz, a research peptide of significant interest, is known for its dual agonist activity on glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) receptors. This peptide has been extensively studied in rodent models, particularly rats, to explore its metabolic effects and potential therapeutic applications in various conditions.
Additional studies examining melanocortin receptor agonists support the role of PT-141 in modulating sexual behaviors across sexes through central nervous system pathways. The involvement of the melanocortin system highlights the relevance of PT-141 peptide in experimental research exploring neural control of sexual function.
Furthermore, mazdutide has been associated with reductions in liver fat content and improvements in insulin sensitivity in clinical trials, highlighting its potential for treating non-alcoholic fatty liver disease and type 2 diabetes.
GLP-3 RT (Retatrutide) is a novel investigational peptide being explored for its potential research applications in metabolic disorders, particularly obesity and type 2 diabetes. Also known as LY3437943, it functions as a triple receptor agonist — a glp3 peptide that targets the GLP-1, GIP, and glucagon receptor pathways simultaneously
Required actions (3)
Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number "733652" in the subject line of the email.
Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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