Gram Peptides
FDA issued a warning letter to Gram Peptides (Bernard Gramlich, Rancho Santa Fe, CA) on March 31, 2026, after reviewing the company's website and finding it offered Retatrutide, Tirzepatide, and Bacteriostatic Water for Injection for sale as unapproved new drugs. Despite 'Research Use Only' disclaimers, the website's marketing claims—describing appetite suppression, weight loss, glucose regulation, and metabolic benefits—established intended human drug use under the FD&C Act. FDA cited violations of sections 301(d) and 505(a) of the FD&C Act and warned that failure to correct may result in seizure or injunction.
Flagged claims (6)
GLP-1-R peptide acts through coordinated activation of: GLP-1 receptors – improving glucose response, slowing gastric emptying, and reducing appetite.
Benefits of GLP-2 Peptide . . . o Metabolic Regulation – Studied for its ability to lower glucose and support balanced insulin levels. o Weight Management – Associated with significant decreases in body weight in both animal and human studies. o Improved Lipid Profiles – Research shows reductions in triglycerides and improved cholesterol ratios.
[I]nfluences appetite suppression, insulin sensitivity, thermogenesis, and fat-oxidation models.
not intended for human consumption, medical use, or veterinary use
[D]emonstrated significant potential for reducing body weight, improving glucose handling, and enhancing lipid metabolism.
Research Use Only
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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