Warning Letter - PekCura Labs - Unapproved GLP-1 Drugs Sold Online
Summary
The FDA issued a Warning Letter to PekCura Labs (Pensacola, FL) on March 31, 2026, finding that the company sells unapproved new drugs including GLP-1-S, GLP-2-T, GLP-3-R, and Bacteriostatic Water through its website pekcuralabs.com. FDA reviewed the website in January 2026 and determined these products are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), not generally recognized as safe and effective, with no approved applications under section 505. The introduction or delivery of these products into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA requires a written response within fifteen working days detailing corrective steps or reasoning for non-compliance; failure to adequately address the matter may result in seizure and injunction.
Companies selling peptide-based products (GLP-1, GLP-2, GLP-3 analogues, amylin analogs, or combination products) online with clinical outcome claims should review whether their labeling and marketing establish "intended use" as drugs under 21 U.S.C. 321(g)(1), regardless of disclaimer language. FDA's evidence here included published study references and specific outcome data (cardiovascular endpoints, HbA1c reductions, body weight loss percentages) cited on product webpages—these constitute evidence of intended use under 21 CFR 201.128.
About this source
FDA Warning Letters are public notifications to firms the agency believes are significantly violating FDA regulations. Common triggers include Current Good Manufacturing Practice violations, unauthorized drug claims, substandard clinical trial conduct, unapproved marketing, and tobacco sales to minors. Letters require a written response within 15 working days. Around 75 letters land each month across drug manufacturers, medical device makers, tobacco retailers, and dietary supplement companies. Watch this if you run a regulated manufacturing operation, advise on FDA compliance, defend companies in enforcement matters, or track quality-system failures that precede recall events. GovPing publishes each letter with the recipient, agency division, and cited violations.
What changed
FDA's Warning Letter identifies that PekCura Labs violated the FD&C Act by introducing unapproved new drugs into interstate commerce. The products—GLP-1-S, GLP-2-T, GLP-3-R peptide products, and Bacteriostatic Water—lack FDA-approved applications under section 505 and are not generally recognized as safe and effective. The agency found the firm's "research use only" labeling claims contradicted by website marketing materials that describe clinical outcomes including cardiovascular benefits, HbA1c reductions, and body weight loss data.
Pharmaceutical manufacturers and distributors selling peptide products, GLP-1 analogues, or compounding pharmacy products marketed for human use should review their product labeling and marketing materials against FDA's intended-use standards. Firms with similar "research use only" or "not for human consumption" disclaimers alongside clinical outcome claims may face similar enforcement risk. Response to FDA is mandatory within fifteen working days; failure to address violations could result in seizure and injunction.
What to do next
- Respond in writing within fifteen working days of receipt of this letter with specific steps taken to correct any violations
- Include copies of related documentation and an explanation of each step being taken to prevent recurrence of violations
- If corrective action cannot be completed within fifteen working days, state the reason for delay and time within which corrections will be completed
Archived snapshot
Apr 8, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Delivery Method: Via Email Product: Drugs Recipient: Jonathan Snider, Owner Jonathan Speck, Owner PekCura Labs 3210 Bayou Blvd
Pensacola, FL 32503
United States
contact@pekcuralabs.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States
WARNING LETTER
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:
GLP-1-S (all variations)
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, nonfatal
myocardial 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).”
GLP-2-T (all variations)
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).”
GLP-3-R (all variations)
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).”
Cag (1mg) Tirz (10mg) Blend
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.”
Bacteriostatic Water (all variations)
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).
Conclusion
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.
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:
04/07/2026
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