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CRITICALPeptide

Peptide Partners LLC

FDA issued a warning letter to Peptide Partners LLC (Zachary David Hoff, Sarasota, FL) in August 2026 for selling multiple unapproved injectable drug products — including semaglutide, tirzepatide, retatrutide, elamipretide, tesamorelin, bremelanotide, and bacteriostatic water — without FDA-approved applications, in violation of sections 301(d) and 505(a) of the FD&C Act. The firm's website contained numerous drug-intended-use claims referencing disease treatment, metabolic improvement, cancer therapy, and neuroprotection, despite 'research use only' disclaimers. FDA flagged the products as posing serious public health risks due to their injectable nature. The letter demands a written corrective response within 15 business days and warns that failure to comply may result in seizure or injunction.

Retatrutide, a new drug for diabetes and obesity, helps lower bad fats in the blood . . . part of Retatrutide's effectiveness in improving cholesterol levels comes from its direct action on the liver.

Scientists have discovered how the weight-loss drug Retatrutide can also help treat a type of breast cancer that is more common in obese patients . . . made the cancer cells more sensitive to chemotherapy . . . uncover[ing] a new way that obesity affects cancer and suggests that drugs like Retatrutide could be used to improve cancer treatment in obese patients.

This research explains how tirzepatide . . . mainly activates the GIP receptor strongly but only partly activates the GLP-1 receptor . . . [which] may help explain why tirzepatide is effective in lowering blood sugar and reducing weight.

This laboratory study . . . suggests that semaglutide could have potential benefits for bone health by promoting the generation of new bone tissue.

SS-31 helps the cells to clean out waste and damaged parts . . . suggesting it could be a promising agent for treating liver inflammation.

[R]esearchers investigated how Tesamorelin affects the liver in people with HIV-associated fatty liver disease . . . and found that the drug changed the activity of genes involved in inflammation, tissue repair, and cell division . . . provid[ing] important insights into the molecular mechanisms by which Tesamorelin improves liver health in this patient population.

Retatrutide . . . can activate three different hormone receptors in the body that control appetite and metabolism . . . allow[ing] it to effectively 'talk' to all three at once, leading to its powerful effects on weight loss and blood sugar control.

[T]his lab experiment . . . [suggests] that semaglutide might help improve metabolism by making muscle cells better at producing energy, even if it doesn't directly fix the insulin resistance problem.

PT-141 works by binding to and activating specific protein receptors on cell surfaces called melanocortin receptors . . . important for understanding how the drug might work in the body to affect sexual function and other processes controlled by these receptors.

This study shows that tirzepatide . . . has direct protective effects on the kidneys, which could be beneficial for patients with diabetic kidney disease.

This study shows that tirzepatide . . . help[s] improve blood sugar and lipid levels without increasing fat mass, offering a better understanding of how tirzepatide works to improve metabolic health in diabetes and obesity.

This study discovered that bremelanotide can kill brain cancer cells (glioblastoma) grown in laboratory culture dishes without harming normal cells.

[T]his laboratory study . . . suggests that semaglutide could have a protective effect on brain cells, which might be relevant for neurodegenerative diseases like Alzheimer's.

for research use only

This lab study looked at how the peptide SS-31 could protect eye cells from damage . . . when the cells were treated with SS-31 beforehand, they were better able to survive and had less damage . . . suggest[ing] that SS-31 could be a potential treatment to protect the retina.

Send your written response to [email protected] within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

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