PekCura Labs
FDA issued a warning letter to PekCura Labs (Jonathan Snider and Jonathan Speck, Pensacola, FL) on March 31, 2026, after reviewing their website in January 2026. The agency found that PekCura Labs was selling injectable peptide products marketed as 'GLP-1-S,' 'GLP-2-T,' 'GLP-3-R,' and 'Bacteriostatic Water' — all unapproved new drugs under section 505(a) of the FD&C Act — with product pages making explicit disease-treatment and body-weight-reduction claims referencing clinical studies. Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on the marketing language, and warned that failure to correct violations could result in seizure and injunction.
Flagged claims (11)
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).
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).
These effects are attributed to its multi-receptor mechanism enhancing energy expenditure, insulin secretion, and lipid metabolism (Abouelmagd et al., 2025).
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.
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-1-S has also been associated with changes in cardiovascular endpoints in long duration studies.
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.
Research, [sic] Development [sic] use only
Reductions in fat mass, as confirmed via body composition studies, indicate preferential loss of adiposity over lean mass (Sokary & Bawadi 2025).
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.
are Not [sic] for Human [sic] consumption of any kind
Required actions (3)
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.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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