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WARNING LETTER

Gram Peptides MARCS-CMS 721806 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
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

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