Prime Sciences
FDA issued a warning letter to Prime Sciences (Scottsdale, AZ) on March 31, 2026, after reviewing their website and finding that they were selling unapproved new drugs — including Cagrilintide, Retatrutide, Semaglutide, Tirzepatide, Mazdutide, and BAC water — in violation of sections 301(d) and 505(a) of the FD&C Act. Despite labeling the products as 'for laboratory research purposes only,' the website's marketing copy made clear the products were intended for human use in weight loss and diabetes management. FDA warned that failure to correct these violations could result in seizure and injunction, and required a written response within fifteen working days.
Flagged claims (11)
Application: Research peptide with potential in diabetes management and obesity treatment.
Ozempic – Weight Loss Supplement.
Retatrutide is a drug that works similarly to semaglutide and tirzepatide, but works in three different ways. Semaglutide targets your receptor of the GLP-1 hormone, which stabilizes your blood sugar, helping to reduce cravings while helping you to eat less, as well as slowing down your digestive system to help you feel fuller longer.
Tirzepatide therapy benefits include: o A phase 3 randomized, controlled clinical trial demonstrated that Tirzepatide led to a 20 percent reduction in body weight o Stimulates the production of insulin to lower blood sugar o Reduces appetite by slowing the time it takes the stomach to empty
Enhanced glycemic control: In patients with type 2 diabetes, mazdutide has been shown to significantly reduce blood glucose levels (HbA1c) and improve insulin sensitivity.
Retatrutide has shown higher weight loss results in clinical trials, with an average of up to 28% body weight reduction, compared to around 15% with semaglutide or Tirzapeptide.
Application: Functionally, Tirzepatide stimulates insulin release from the pancreas and reduces hyperglycemia.
In one study, weight loss of 25% or more was achieved in 40.4% of patients receiving Cagri compared to 16.2% with semaglutide alone.
Semaglutide peptide therapy benefits include: o Participants taking semaglutide lost an average of 15.2% of their initial body weight . . . o Stimulates the pancreas to produce insulin and reduces the hunger hormone ghrelin o Reduces blood sugar levels to promote weight loss
Lowered cardiometabolic risk factors: . . . Reduced blood pressure . . . Decreased total cholesterol and LDL . . . Lowered triglycerides
Significant weight loss: In a phase 3 trial (GLORY-1), once-weekly mazdutide led to an average body weight reduction of up to 14.8%.
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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