Warning Letter: Gram Peptides - Unapproved Retatrutide and Tirzepatide Sales
Summary
FDA issued a Warning Letter to Gram Peptides (Bernard Gramlich) on March 31, 2026, for marketing and selling unapproved new drugs, specifically Retatrutide (labeled as "GLP-1-R peptide") and Tirzepatide (labeled as "GLP-2 peptide"), in violation of sections 301(d) and 505(a) of the FD&C Act. The agency determined the products are "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective, and no approved applications are in effect for them. FDA has given the firm fifteen working days to respond with specific corrective steps or reasoning why no violations exist.
Firms selling peptide products labeled as "research use only" should audit their websites for any statements describing metabolic, weight-management, glucose-regulation, or appetite-suppression effects, as FDA treats such claims as evidence of intended drug use regardless of disclaimer language. The Retatrutide and Tirzepatide products cited here are the same active ingredients found in FDA-approved GLP-1/GIP receptor agonist drugs, placing them squarely in the unapproved-new-drug category even when marketed for animal or laboratory research.
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 determined that Gram Peptides violated the FD&C Act by selling Retatrutide and Tirzepatide without approved applications, despite labeling them "for research use only." The agency found evidence of intended drug use based on website claims about appetite suppression, glucose response, weight management, and lipid metabolism. Bacteriostatic Water for Injection sold alongside the peptides was also deemed a drug under the Act.\n\nPeptide compounders and research chemical suppliers should review their product labeling and marketing claims carefully. FDA's analysis treats health-related claims on product pages—including metabolic benefit statements—as evidence of intended drug use regardless of disclaimers. Firms receiving Warning Letters face 15 working days to respond or risk seizure and injunction.
What to do next
- Notify FDA in writing within fifteen working days of receipt of the letter of specific steps taken to correct violations, including an explanation of each step to prevent recurrence and copies of related documentation
- If products are not in violation, provide reasoning and supporting information for FDA consideration
- If corrective action cannot be completed within fifteen working days, state the reason for the delay and time within which corrections will be completed
- Send response to FDAAdvisory@fda.hhs.gov with firm name and unique identifier '721806' in the subject line
Penalties
Failure to adequately address the matter may lead to regulatory or legal action including seizure and injunction
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: Bernard Gramlich Gram Peptides PO Box 9227
Rancho Santa Fe, CA 92067
United States
support@grampeptides.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States
WARNING LETTER
March 31, 2026
RE: 721806
Bernard Gramlich:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://grampeptides.com from January to March 2026. The FDA has observed that your website offers “Retatrutide” (also referred to by your firm as “GLP-1-R peptide”) and “Tirzepatide” (also referred to by your firm as “GLP-2 peptide”) and “Bacteriostatic Water for Injection” (hereinafter Gram Peptides 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 Use Only,” and “not intended for human consumption, medical use, or veterinary use,” 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:
Retatrutide (also referred to as “GLP-1-R Peptide”)
On the webpage https://grampeptides.com/product/retatrutide/:
- “[I]nfluences appetite suppression, insulin sensitivity, thermogenesis, and fat-oxidation models.”
- “[D]emonstrated significant potential for reducing body weight, improving glucose handling, and enhancing lipid metabolism.”
“GLP-1-R peptide acts through coordinated activation of: GLP-1 receptors – improving glucose response, slowing gastric emptying, and reducing appetite.”
Tirzepatide (also referred to as “GLP-2 Peptide”)
On the webpage https://grampeptides.com/product/tirzepatide/:“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.”
Bacteriostatic Water for Injection
Your firm offers “Bacteriostatic Water for Injection” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the two above-mentioned GLP products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water for Injection” to be used in combination for injection. Therefore, your “Bacteriostatic Water for Injection” is a drug.
Your Gram Peptides 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 “721806” 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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