← All FDA warning letters

FDA Warning Letter · #733652

NuScience Peptides LLC — FDA Warning Letter (August 24, 2026)

Issued August 24, 2026Status: activeCenter for Drug Evaluation and Research (CDER)

Primary Source

View the original FDA letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026

Summary

Company
NuScience Peptides LLC
Letter number
#733652
Issue date
August 24, 2026
Subject
Unapproved New Drugs/Misbranded

What FDA cited

Violations were identified and documented during a review of your website nusciencepeptides.com in July 2026. Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” 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).

Quoted verbatim from the FDA warning letter dated 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.

Violations were identified and documented during a review of your website nusciencepeptides.com in July 2026. Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” 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.

“GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” 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).

Source: U.S. Food and Drug Administration. Quoted as a verbatim excerpt for editorial commentary; no claim is made beyond what FDA itself has published. The full letter is available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026

What FDA warning letters mean

A warning letter is FDA's principal means of telling a company that the agency considers something it's doing — a marketing claim, a manufacturing practice, a labeling choice — to violate the Federal Food, Drug, and Cosmetic Act. Companies typically have 15 working days to respond.

A warning letter is not a recall, a criminal charge, or a finding that the company has broken the law. It is the start of a regulatory conversation. FDA may issue a close-out letter once it is satisfied that the company has corrected the cited issues.

For compounded GLP-1 telehealth providers, the most common citations involve unapproved new drug claims, misbranding, and the use of bulk drug substances not on FDA's approved list under FDCA sections 503A and 503B.

Where to get GLP-1 safely: vetted online providers

Vetted telehealth providers that prescribe online. We compare pricing, form, and states served.

No insurance needed · vetted by our editors

WeightLossRankings.org is reader-supported. When you buy through links on our site, we may earn an affiliate commission. Learn more

8.1

GobyMeds

Budget-conscious shoppers

7.7

Ivim Health

Budget-conscious shoppers

7.4

Brightmeds

Compounded or brand GLP-1 bundled with TRT and peptides for men

Other warning letters in our database

View the full database →

Editorial Disclaimer

FDA warning letters are public regulatory communications and do not, on their own, indicate that a company has done anything illegal. Companies often respond to warning letters with corrective action, and many letters are eventually closed out. The full text of this letter is available on fda.gov via the link above.

Key terms, explained

New to GLP-1s? Tap any term for a quick, plain-English definition.