Tex Peptides — FDA Warning Letter (August 24, 2026)

Summary

Company

TXP Innovations LLC (dba Tex Peptides)

Letter number

#735067

Issue date

August 24, 2026

Subject

Unapproved New Drugs/Misbranded

Word for word, from the letter of August 24, 2026

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

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.

Violations were identified and documented during a review of your website texpeptide.com in July 2026. Based on our review, “Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” 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).

This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Based on a review of your website,“Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” are drugs under 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 any function of the body.1 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:

Your firm offers “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the six above-mentioned products. The sale of these products together demonstrates that you intend your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” to be used in combination for injection. Therefore, your “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” is a drug.

Semaglutide (GLP-1 SEM),” “Tirzepatide (GLP-2 TRZ),” “Retatrutide (GLP-3 RT),” “SS-31 (Elamipretide),” “Tesamorelin,” “PT-141 (Bremelanotide),” and “Bacteriostatic Water 0.9% Benzyl Alcohol (10 ml)” 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 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).

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026

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