Prime Sciences(RE: 721805)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

March 31, 2026

RE: 721805

Prime Sciences:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://prime-sciences.com/ from January to March 2026. The FDA has observed that your website offers “Cagrilintide,” “GLP1-R,” “GLP1-S,” “GLP1-T,” “Mazdutide,” and “BAC water” (hereinafter Prime Sciences products) for sale in the United States. Based on our review, these products 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.

Despite statements on your product labeling marketing your products for “laboratory research purposes only” and “not for human consumption, medical use or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by 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 function of the body.

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:

Cagrilintide
On the webpage https://prime-sciences.com/product/cagrilintide:

• “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.”

• “Mechanism of action: Cagrilintide promotes weight loss through various mechanisms: Slowing gastric emptying. Reducing food intake. Modulating postprandial glucose spikes. Inducing satiety (feeling of fullness).”

• “Application: Research peptide with potential in diabetes management and obesity treatment.”

GLP1-R (10MG) (identified as Retatrutide)
On the webpage https://prime-sciences.com/product/glp1-r:

• “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.”

• “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.”

GLP1-S (10MG) (identified as Semaglutide)
On the webpage https://prime-sciences.com/product/glp1-s:

• “Ozempic – Weight Loss Supplement.”

• “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”

• “Application: Research peptide with potential in diabetes management and obesity treatment.”

GLP1-T (10MG) (identified as Tirzepatide)
On the webpage https://prime-sciences.com/product/glp1-t:

• “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”

• “Application: Functionally, Tirzepatide stimulates insulin release from the pancreas and reduces hyperglycemia.”

MAZDUTIDE (10MG)
On the webpage https://prime-sciences.com/product/mazdutide:

• “Mazdutide peptide therapy benefits include:
  o Weight Management
  ???? 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%.”

• “Improved metabolic health
  o Enhanced glycemic control: In patients with type 2 diabetes, mazdutide has been shown to significantly reduce blood glucose levels (HbA1c) and improve insulin sensitivity.
  o Reduced liver fat . . . some participants in a phase 3 trial achieving up to an 80% reduction.”
  o Lowered cardiometabolic risk factors: . . . Reduced blood pressure . . . Decreased total cholesterol and LDL . . . Lowered triglycerides”

BAC water
Your firm offers a “Reconstitution Kit” for sale, which contains “BAC water” and a syringe. This kit is offered for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of a kit containing the “BAC water” and a means of injection (a syringe) with these peptide drugs demonstrates that you intend for the “BAC water” to be used in combination for injection. Therefore, your “BAC water” is a drug.

Your Prime Sciences products 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 above-described 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).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.

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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “721805” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration