TXP Innovations LLC dba Tex Peptides
FDA issued a warning letter to TXP Innovations LLC dba Tex Peptides (CEO Felicia Romero, Dallas TX) following a July 2026 review of texpeptide.com, finding that seven products — Semaglutide (GLP-1 SEM), Tirzepatide (GLP-2 TRZ), Retatrutide (GLP-3 RT), SS-31 (Elamipretide), Tesamorelin, PT-141 (Bremelanotide), and Bacteriostatic Water 0.9% Benzyl Alcohol — are unapproved new drugs marketed with explicit therapeutic and disease-treatment claims in violation of sections 301(d) and 505(a) of the FD&C Act. The products are injectable, raising heightened public health concern. FDA demanded a written corrective response within 15 business days and warned that failure to comply may result in seizure or injunction.
Flagged claims (10)
In addition to its glucose-lowering effects, GLP-1 SEM has been shown to support weight loss by reducing appetite and promoting a feeling of fullness, making it a valuable therapeutic candidate in obesity management. Research also suggests potential benefits for cardiovascular health, liver function, and neuroprotection, expanding its relevance beyond diabetes care.
PT-141, also known as bremelanotide . . . is specifically researched for its ability to increase arousal and desire. PT-141 targets the central nervous system directly to improve libido and pleasure. It's an effective and powerful enhancer for both mood and your senses.
GLP-3 RT offers a unique and comprehensive approach to regulating glucose metabolism, energy balance, and weight management.
Tesamorelin is a synthetic peptide analog of Growth Hormone-Releasing Hormone (GHRH), a naturally occurring hormone that stimulates the pituitary gland to release growth hormone (GH). By mimicking the natural activity of GHRH, Tesamorelin effectively increases the production and secretion of growth hormone, which in turn elevates levels of insulin-like growth factor-1 (IGF-1) in the body.
By binding to GLP-1 receptors, it enhances insulin secretion, suppresses glucagon release, and slows gastric emptying, ultimately helping to regulate blood glucose levels. This makes GLP-1 SEM a key area of interest in the management of type 2 diabetes, obesity, and metabolic disorders.
This peptide has been widely studied for its antioxidant and cytoprotective properties, making it a promising therapeutic candidate for conditions linked to mitochondrial dysfunction.
Early research suggests that GLP-3 RT may provide superior outcomes compared to GLP-1 or dual agonists alone, including greater weight reduction, improved insulin sensitivity, enhanced lipid metabolism, and better long-term metabolic stability. Additionally, studies are investigating its potential in cardiovascular protection, liver health (NAFLD/NASH), and neuroendocrine regulation.
Beyond its primary effects on glucose metabolism and weight loss, GLP-2 TRZ is being investigated for its potential in cardiovascular health, lipid regulation, and reducing systemic inflammation. Its role in insulin sensitivity, appetite suppression, and long-term metabolic improvements makes it a promising therapeutic option in endocrinology and obesity research.
GLP-2 TRZ enhances insulin secretion, reduces glucagon levels, and promotes appetite regulation, offering a powerful approach to improving blood sugar control and weight management.
SS-31 helps stabilize mitochondrial membranes, reduce oxidative stress, and improve electron transport chain efficiency, ultimately enhancing cellular energy production (ATP).
Required actions (2)
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 "735067" in the subject line of the email.
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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