PekCura Labs

March 31, 2026

RE: 721709

Jonathan Snider and Jonathan Speck:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pekcuralabs.com/ in January 2026. The FDA has observed that your website offers “GLP-1-S” (all variations), “GLP-2-T” (all variations), “GLP-3-R” (all variations), and “Bacteriostatic Water” (all variations) (hereinafter PekCura Labs products) for sale in the United States. Based on our review, these products 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).

These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.

Despite statements on your product labeling marketing your products for “Research, [sic] Development [sic] use only” and “are Not [sic] for Human [sic] consumption of any kind,” 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 for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.

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:

On the webpages https://pekcuralabs.com/shop/pcl-glp-1-s-5mg/, https://pekcuralabs.com/shop/pcl-glp-1-s/, https://pekcuralabs.com/shop/gmp-pcl-glp-1-s/, and https://pekcuralabs.com/shop/gmp-pcl-glp-1-s-5mg/:

“What is GLP-1-S? . . . In multiple studies utilizing once-weekly subcutaneous administration at a 2.4 mg dose, GLP-1-S consistently induced substantial reductions in body weight under experimental conditions. . . . GLP-1-S has also been associated with changes in cardiovascular endpoints in long duration studies. . . . GLP-1-S 2.4 mg administered weekly was associated with a reduced incidence of composite cardiovascular outcomes, including death from cardiovascular causes, nonfatalmyocardial infarction, and nonfatal stroke (Lincoff et al., 2023). An earlier trial using 0.5 mg and 1.0 mg doses similarly reported a statistically significant reduction in the rate of first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in subjects with type 2 diabetes treated with GLP-1-S relative to placebo (Marso et al., 2016).”

On the webpages https://pekcuralabs.com/shop/pcl-glp-2-t-10mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-15mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-30mg/, https://pekcuralabs.com/shop/pcl-glp-2-t-60mg/, https://pekcuralabs.com/shop/gmp-pclglp-2-t-15mg/, and https://pekcuralabs.com/shop/gmp-pcl-glp-2-t/:

“What is GLP-2-T? . . . Across randomized controlled trials, GLP-2-T induced dose-dependent reductions in HbA1c and body weight, outperforming GLP-1 receptor agonists and basal insulin comparators (Karagiannis et al. 2022). Reductions in fat mass, as confirmed via body composition studies, indicate preferential loss of adiposity over lean mass (Sokary & Bawadi 2025).”

On the webpages https://pekcuralabs.com/shop/pcl-glp-3-r-10mg/ and https://pekcuralabs.com/shop/gmp-pcl-glp-3-r-30mg/:

“What is GLP-3-R? . . . In controlled studies, GLP-3-R led to significant, dose-dependent reductions in body weight (up to -24.2%), BMI, and waist circumference over 48 weeks, alongside improvements in metabolic markers such as HbA1c, fasting glucose, and blood pressure. These effects are attributed to its multi-receptor mechanism enhancing energy expenditure, insulin secretion, and lipid metabolism (Abouelmagd et al., 2025).”

On the webpage https://pekcuralabs.com/shop/pcl-ct-blend/:

“What is C/T Blend? . . . The pairing of Cagrilintide’s amylinergic modulation with GLP-2-T’s incretin-based pathways presents a complementary approach to the investigation of integrated energy balance and metabolic regulation.”

Your firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug.

Your PekCura Labs products 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 above-described 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).

The violations cited in this letter are 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 lead to regulatory or 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 correct 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. Please include your firm name and the unique identifier “721709” in the subject line of the email.