Prime Vitality, Inc. dba Prime Peptides - 695156 - 12/10/2024

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WARNING LETTER 695156

December 10, 2024

Dear Curtis Miller:    

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://primepeptides.co in October 2024 and has observed that your website offers various products as “peptides” including, “Semaglutide” and “Retatrutide.”  We have also reviewed your social media websites at www.facebook.com/primepeptidesco, www.instagram.com/primepeptidesco, and www.youtube.com/@PrimePeptide.  Your social media websites direct consumers to your https://primepeptides.co website to purchase your products.  As described below, your “Semaglutide” and “Retatrutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Despite statements on your product labeling marketing your products for “research purposes only” and “not for human consumption or clinical 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 to prevent, treat, or cure disease conditions and/or affect the structure or function of the body.  Examples of claims observed on your websites that establish the intended use of your products as drugs for human use include, but may not be limited to, the following:

On your webpage https://primepeptides.co/products/buy-semaglutide:

• “Semaglutide reduces cardiovascular events. The SELECT trial showed that semaglutide reduced major adverse cardiovascular events by 20% in adults with preexisting cardiovascular disease and obesity. This included fewer heart attacks and strokes compared to those on placebo.”

• “Semaglutide improves insulin resistance. A study found that semaglutide helped improve insulin sensitivity in participants, which is crucial for managing and preventing type 2 diabetes. This improvement was seen alongside significant weight loss.”

• “Mechanism of Action[,] GLP-1 Receptor Activation[,] Appetite Regulation[,] Slowing Gastric Emptying[,] Enhancing Insulin Secretion[,] Reducing Glucagon Production[,] Cardiovascular Benefits[,and] Energy Expenditure and Lipid Metabolism”

On your webpage https://primepeptides.co/products/buy-retatrutide:

• “Retatrutide improves glycemic control. In a study involving patients with type 2 diabetes, retatrutide reduced HbAlc levels by up to 2.02% at 24 weeks. This indicates better blood sugar control, which is crucial for managing diabetes.”

• “Retatrutide enhances cardiometabolic health. Participants in the trial experienced improvements in cardiometabolic measures, including reductions in waist circumference, blood pressure, and lipid levels. For examples, waist circumference decreased by up to 19.6 cm in some participants.”

• “Retatrutide reduces liver fat. A 48-week study showed that retatrutide significantly reduced liver fat in obese patients. Those taking 8 mg and 12 mg doses saw liver fat reductions of 23.8% and 25.9% respectively, which is beneficial for liver health.”

On your blog post “Top Weight Loss Peptides: Semaglutide, Tirzepatide & More” on your webpage https://primepeptides.co/blogs/peptides/weight-loss-peptides: 
• “Top Peptides for Weight Loss: A Quick Guide” with a graphic of a woman with a measuring tape around her waist.

o “Semaglutide . . .Pros: Reduces body weight, controls blood sugar levels, FDA-approved for weight management . . . Statistics: Clinical trials show up to 15% body weight loss”

o “Retatrutide . . . Pros: Targets 3 pathways, most weight loss, treats fatty live . . . Fun Fact: Known as the ‘triple agonist’ for its multi-pathway approach. Statistics: Early trials indicate up to 25% body weight loss.”

• “Semaglutide can help people who are obese or overweight lose a considerable amount of weight and lower their risk of heart disease, diabetes, and cancer when used in combination with diet and exercise.”

• “Retatrutide is an emerging peptide developed by Lilly for treating obesity, diabetes, and fatty liver disease. It is common for diabetes medications to be used for weight management, and Retatrutide is a notable example of this trend.”

On your social media websites at www.facebook.com/primepeptidesco and www.instagram.com/primepeptidesco:
• June 28, 2024 post: “Thanks so much for sharing your experience. We’re so happy to hear you’re loving the benefits! Semaglutide is a GLP-1 receptor agonist known for its significant impact on weight loss, glycemic control, and cardiovascular risk reduction. . . Safe & Effective: Trusted by health professionals worldwide . . . #shareyourexperience #sharingexperience . . . #fitness” with an image of a vial of semaglutide and the text “‘Highly Recommend[,]’ I’ve been using Semaglutide for a few months, and it’s been a game changer. My health and energy levels have improved significantly!”

• June 23, 2024 post: “Customer Review Highlight! . . . Hearing about your positive experience means everything to us. So glad you’re loving the benefits! . . . Retatrutide is a new medicine that helps control blood sugar and supports weight loss. . . . Safe & Effective: Trusted by health professionals worldwide . . . #shareyourexperience #sharingexperience . . . #fitness” with an image of a woman in active sportswear, a vial of retatrutide and the text “TESTIMONIALS . . . ‘Impressive Weight Loss[,]’ Retatrutide has been impressive for my weight loss journey. I’ve seen significant results in just a few weeks. Highly recommend!”

On your YouTube website at www.youtube.com/@PrimePeptide, August 30, 2024 post “Top 5 Peptides for Weight Loss”: 
• From the text below the video: “Top 5 Peptides for Weight Loss │Effective Fat-Burning Peptides . . . Learn how these peptides work, their potential benefits, and how they can help you achieve your weight loss goals. What You’ll Learn: How Semaglutide and Tirzepatide mimic natural hormones to reduce appetite and promote fat loss. The triple-action approach of Retatrutide for maximum weight reduction.”

• From the video: “GLP-1 peptides also improve your overall health by controlling blood sugar and lowering the risk for heart problems, which are often an issue for people who are overweight. Let’s start by talking about the most popular weight loss peptide, semaglutide. Semaglutide is a medication that can help people with weight-related health issues like type 2 diabetes, high cholesterol, and high blood pressure.”

• From the video: “Another exciting peptide is retatrutide. It was developed by Lilly for treating obesity, diabetes, and fatty liver disease . . . What sets retatrutide apart is its triple action approach. Unlike other medications like semaglutide which only targets GLP-1 receptors, retatrutide works on three types of receptors; GIP, GLP-1, and glucagon. This unique combination helps extend feelings of fullness by slowing down the rate at which the stomach empties after meals. It also helps stabilize blood sugar levels by boosting insulin release and converting excess sugar into glucose.”

Your “Semaglutide” and “Retatrutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).  Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 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, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

This letter is 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 result in 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.

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