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EnforcementMarch 31, 2026

FDA Issues Warning Letters to Online Research-Peptide Sellers Gram Peptides, Prime Sciences, and Mile High Compounds

Warning letters issued March 31, 2026

On March 31, 2026, the FDA issued warning letters to Gram Peptides, Prime Sciences, and Mile High Compounds LLC after reviewing their websites. According to the letters, the sites offered products including retatrutide, tirzepatide, semaglutide, and cagrilintide for sale in the United States.

The FDA stated that the products are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. The three letters share one date, one issuing office, and one legal theory, and they are reported here as a single grouped enforcement event on that basis.

A central point in the letters concerns labeling. The FDA stated that research use only labeling did not change its conclusion where the evidence showed an intended human use. In the agency's reading, the intended use shown by the evidence, not the disclaimer alone, decides the regulatory classification.

A warning letter states the FDA position as an allegation and enforcement step; it is not a court judgment. None of the products named in these letters is FDA-approved, and approval in this field belongs only to a specific approved drug product and its labeled indication.

RetatrutideTirzepatideSemaglutideCagrilintide

Sources

  • FDA warning letter - Gram Peptides, MARCS-CMS 721806, March 31, 2026
  • FDA warning letter - Prime Sciences, MARCS-CMS 721805, March 31, 2026
  • FDA warning letter - Mile High Compounds LLC, MARCS-CMS 721600, March 31, 2026

Frequently Asked Questions

What did the FDA do on March 31, 2026?▾

The FDA issued warning letters to Gram Peptides, Prime Sciences, and Mile High Compounds LLC after reviewing their websites, which offered products including retatrutide, tirzepatide, semaglutide, and cagrilintide for sale in the United States.

What did the FDA say about these products?▾

The FDA stated that the products are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.

What did the FDA say about research use only labeling?▾

The FDA stated that research use only labeling did not change its conclusion where the evidence showed an intended human use.

Is a warning letter a court judgment?▾

No. A warning letter is an FDA allegation and enforcement step that states the agency position. It is not a court judgment.

Regulatory reporting only. This article describes FDA actions on specific drug products - it is not usage guidance. Peptide Stores Online sells compounds strictly for laboratory research use, not for human consumption.

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All products listed on Peptide Stores Online are for in-vitro laboratory and educational research purposes only. Not for human or animal consumption. Not evaluated by the Food and Drug Administration. Not intended to diagnose, treat, cure, or prevent any disease or condition. All sellers and buyers agree to full research-use-only terms at account creation. Peptide Stores Online assumes no liability for misuse of any product listed on this platform.