Stability and storage Findings

FDA Review Violations were identified and documented during a review of your website texpeptide.com in July 2026. Based on our review, “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 (10 ml)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website,“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 (10 ml)” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.1 Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: GLP-1 SEM (Semaglutide) On the webpage https://texpeptide.com/product/glp-1-sem/: “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.” “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.” GLP-2 TRZ (Tirzepatide) On the webpage https://texpeptide.com/product/glp-2-trz/: “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.” “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-3 RT (Retatrutide) On the webpage https://texpeptide.com/product/glp-3-rt/: “GLP-3 RT offers a unique and comprehensive approach to regulating glucose metabolism, energy balance, and weight management.” “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.” SS-31 (Elamipretide) On the webpage https://texpeptide.com/product/ss-31/: “SS-31 helps stabilize mitochondrial membranes, reduce oxidative stress, and improve electron transport chain efficiency, ultimately enhancing cellular energy production (ATP).” “This peptide has been widely studied for its antioxidant and cytoprotective properties, making it a promising therapeutic candidate for conditions linked to mitochondrial dysfunction.” Tesamorelin On the webpage https://texpeptide.com/product/tesamorelin/: “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.” PT-141 (Bremelanotide) On the webpage https://texpeptide.com/product/pt-141/: “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.” Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml) Your firm offers “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” to be used in combination for injection. Therefore, your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” is a drug. 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 (10 ml)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

There is no written testing program designed to assess the stability characteristics of drug products.

There is no written testing program designed to assess the stability characteristics of drug products.

Drug products are not stored under appropriate conditions of temperature, humidity and light so that their identity, strength, quality, and purity are not affected.

The written stability testing program is not followed.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.