Peak Performance Peptides: FDA Warning Letter (August 24, 2026)

Summary

Company

Peak Performance Peptides

Letter number

#735127

Issue date

August 24, 2026

Subject

Unapproved New Drugs/Misbranded

This letter is one of a run to online sellers of research-use peptides: FDA warning letters to peptide sellers, 2023 to 2026.

FDA’s letter of August 24, 2026 to Peptide Partners LLC also cites its recipient for selling products FDA calls unapproved new drugs.

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 pppepz.com in July 2026. Based on our review, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin”1 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, “Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” 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.2 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:

Bac waterYour firm offers “Bac water” for sale to be used to reconstitute the peptide products sold on your website, which are drugs intended for injection, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bac water” to be used in combination for injection. Therefore, your “Bac water” is a drug.

“Bac water,” “GLP-3R” (retatrutide), “Semaglutide,” “SS-31,” “PT-141,” and “Tesamorelin” 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).

Despite statements on your product labeling marketing your products for “research use only” and “not for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. In addition to the cited drug claims, you market bacteriostatic water as a solvent for reconstituting your products, thus, providing the means to prepare an injectable drug for human administration.

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/peak-performance-peptides-735127-08242026

What FDA warning letters mean

Other warning letters in our database

• BluefitMD — February 20, 2026
• 24HrDoc — February 20, 2026
• Thrive Health Solutions — February 9, 2026
• PQ Pharmacy, LLC — October 10, 2025
• Prime Peptides — December 10, 2024