# Tesamorelin

Tesamorelin is FDA-approved as Egrifta, with a prescription, for one use: extra belly fat in adults with HIV. The evidence grade is moderate-human for that use. It is not approved for weight loss, muscle or healing. Tesamorelin sold online for research is not legal.

Status checked: 2026-10-25. Last verified: 2026-10-25. Primary source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Egrifta, Egrifta WR, Egrifta SV | primary | 2026-10-25 | [source](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75) |
| Class | growth-hormone-axis | primary | 2026-10-25 | [source](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75) |
| Regulatory status | fda-approved | primary | 2026-10-25 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf) |
| Status source read | 2026-10-24 | primary | 2026-10-25 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505) |
| Evidence grade | moderate-human | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) |
| Label dosing | From the Egrifta WR label and the Egrifta SV label. Both are shots under the skin of the belly once a day. Egrifta WR is 1.28 mg a day. The Egrifta SV label gives 1.4 mg a day. The two forms are not swapped for one another. The prescriber sets the dose. | primary | 2026-10-25 | [source](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75) |

## Name

Tesamorelin

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

## Summary

A prescription shot that makes the body release growth hormone. FDA approved it as Egrifta for extra belly fat in adults with HIV.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

## Short answer

Tesamorelin is FDA-approved as Egrifta, with a prescription, for one use: extra belly fat in adults with HIV. The evidence grade is moderate-human for that use. It is not approved for weight loss, muscle or healing. Tesamorelin sold online for research is not legal.

Source: https://peptideindex.ai/methodology#short-answer

## Known risks

- It can raise blood sugar and the chance of diabetes. After 26 weeks in trials, 5% on it had a high long-term sugar reading. On a dummy shot, 1% did [^2].
- It raises IGF-1, a growth signal in the blood. The label says not to use it with an active cancer, and to stop if a cancer comes back [^2].
- It can make the body hold fluid. That can cause swelling, joint pain and a pinched nerve in the wrist [^2].
- In trials, 4% had an allergic reaction such as itching or a rash. A quarter had redness, itching or pain where the shot went in. On a dummy shot, 14% did [^2].
- The label says not to use it in pregnancy [^2]. In the first large trial, more people on it than on a dummy shot quit because of unwanted effects [^13].
- Tesamorelin sold for research is not made under FDA rules. FDA warns that injected products skip some of the body's defenses against germs and toxins [^7].

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

## What nobody knows yet

- Nobody knows how it affects the heart over many years. The label says long-term heart safety has not been shown [^2].
- Nobody knows what years of high IGF-1 levels do to the body. The label says the effects are unknown [^2].
- Nobody knows how long people need to take it. In one trial, the belly fat came back quickly after people stopped [^14].
- It lowered liver fat in two small trials. Nobody knows yet if that prevents liver disease later on [^15] [^16].
- No trial cited here tested it in people without HIV, or for healing or memory, uses some sellers claim [^9] [^13]. A 2026 review found lean body mass rose in people with HIV who took it. Nobody knows if that happens in people without HIV [^17].

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

## What it is

Tesamorelin is a prescription drug. It is a lab-made copy of a natural hormone that tells the body to release growth hormone [^2]. Growth hormone then raises IGF-1, a growth signal in the blood [^2]. FDA first approved it in November 2010, under the brand name Egrifta [^1].

It is a daily shot under the skin of the belly [^2] [^3]. It is approved for adults with HIV who have lipodystrophy. That is a shift in body fat that some HIV medicines can cause, with extra fat deep in the belly [^2] [^17]. The label says it is not for weight loss, because it does not change body weight [^2].

Today it comes in two forms, Egrifta WR and Egrifta SV [^2] [^3]. FDA approved the WR form in March 2025 [^4] [^19].

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

## Where it stands legally

Tesamorelin is FDA-approved: FDA approved it as Egrifta in November 2010 to reduce extra belly fat in adults with HIV who have lipodystrophy [^1] [^2]. That covers Egrifta WR and Egrifta SV, with a prescription, for that one use. It does not cover weight loss, and it does not make tesamorelin sold for research legal [^2] [^7]. Checked 24 October 2026.

There is a gap between the approved use and what sellers offer it for. The label names one use, belly fat in adults with HIV [^2]. In July 2026, FDA reviewed five seller websites [^7] [^8] [^9] [^10] [^23]. They described it for body shape, fat loss, muscle, tissue repair, memory and liver health [^7] [^8] [^9] [^10] [^23]. FDA called every one of those products an unapproved new drug [^7] [^8] [^9] [^10] [^23].

Since March 2020, the law has treated tesamorelin as a biologic, a type of protein drug [^1] [^5]. FDA says the federal compounding rules do not cover biologics [^6]. So pharmacies may not make their own copies of it [^6] [^11]. Tesamorelin is not on FDA's Category 1 or Category 2 lists of raw ingredients for compounding [^21] [^22].

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505

## What the evidence shows

The evidence grade is moderate-human: several trials in people agree that it shrinks deep belly fat in adults with HIV [^13] [^14] [^17] [^18]. All of the trials were in adults with HIV. Most lasted 6 to 12 months.

In a 26-week trial of 412 adults with HIV and extra belly fat, deep belly fat fell by 15.2% on it. On a dummy shot, it rose by 5.0% [^13]. Blood fats also improved [^13]. In a second trial of 404 adults with HIV, deep belly fat fell by 10.9% on it over 6 months. On a dummy shot, it fell by 0.6% [^14]. People who kept taking it for a year kept about 18% less deep belly fat. Those who switched to a dummy shot lost the gain quickly [^14].

Two smaller trials in adults with HIV found it also lowered liver fat. One had 50 people and one had 61 [^15] [^16]. A 2026 review of four trials with 909 people found less deep belly fat and a smaller waist [^17]. It also found more people stopped taking it, though that result was not certain [^17]. A second 2026 review of five trials found similar results [^18].

The trials tested the approved drug in adults with HIV. They tell us nothing about tesamorelin sold for research, which FDA has not approved [^7].

Source: https://pubmed.ncbi.nlm.nih.gov/18057338/

## Legitimate ways to get it

The legal way to get tesamorelin is a prescription for Egrifta WR or Egrifta SV [^1] [^2] [^3]. The label is for adults with HIV who have extra belly fat from lipodystrophy [^2].

The two forms are not swapped for one another. They use different doses and are mixed in different ways [^2]. The maker said Egrifta WR will replace Egrifta SV [^19] [^20].

Because the law treats it as a biologic, pharmacies may not make their own copies [^5] [^6] [^11].

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505

## How people are getting it anyway

This section describes what happens and is not a recommendation.

Outside a prescription, tesamorelin reaches people through online sellers that label it for research use [^7] [^12]. On 24 August 2026, FDA sent warning letters to five such sellers [^7] [^8] [^9] [^10] [^23]. Each letter names tesamorelin [^7] [^8] [^9] [^10] [^23]. Two sellers also offered a mix of tesamorelin and another peptide [^7] [^9].

The sellers' labels said the products were for research only, or not for people [^7] [^8] [^9] [^10] [^23]. FDA said their websites showed the products were meant for people anyway [^7] [^8] [^9] [^10] [^23]. It called them unapproved new drugs, and sending them across state lines breaks federal law [^7]. FDA warns that injected products skip some of the body's defenses against germs and toxins [^7]. It is unclear where and how these products are made [^11].

No FDA page we found names tesamorelin at a clinic, an online prescriber, or as a fake or imported product. So this page does not describe those channels.

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026

## Access routes

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505

### Approved product

Detail: Approved by FDA and sold with a prescription as a daily shot under the skin of the belly. It comes in two forms, Egrifta WR and Egrifta SV, which are not swapped for one another.

Brand names: Egrifta WR, Egrifta SV

Manufacturer: Theratechnologies Inc.

Indication: To reduce extra belly fat in adults with HIV who have lipodystrophy. Not for weight loss.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

## Unofficial channels

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026

### Research use seller

What it is: Sold online labeled for research use or not for people, sometimes mixed with another peptide.

Legal position: FDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026)

Documented risks:

- FDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026)
- FDA says no approved application covers these products, so their safety and benefit for the sellers' uses have not been shown. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026)

Enforcement:

- 2026-08-24: FDA warning letter to an online seller of research-use peptides, including tesamorelin and a tesamorelin blend. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026)
- 2026-08-24: FDA warning letter to an online seller of research-use peptides, including tesamorelin. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026)
- 2026-08-24: FDA warning letter to an online seller of research-use peptides, including tesamorelin and a tesamorelin blend. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026)
- 2026-08-24: FDA warning letter to an online seller of research-use peptides, including tesamorelin. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026)
- 2026-08-24: FDA warning letter to an online seller of research-use peptides, including tesamorelin. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026

## Recruiting trials

Snapshot date: 2026-10-25.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- nct NCT07481734, url https://clinicaltrials.gov/study/NCT07481734, phase Phase 2, title Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study), status recruiting, sponsor Hudson Biotech, countries China, us states none listed
- nct NCT06554717, url https://clinicaltrials.gov/study/NCT06554717, phase Phase 2, title Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV, status recruiting, sponsor Massachusetts General Hospital, countries United States, us states Colorado, Massachusetts
- nct NCT03150511, url https://clinicaltrials.gov/study/NCT03150511, phase Phase 2, title Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury, status recruiting, sponsor Johns Hopkins University, countries United States, us states Maryland

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=tesamorelin+OR+Egrifta&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

### 1. Drugs@FDA: Egrifta, biologic license application 022505

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505

### 2. DailyMed: Egrifta WR prescribing information, revised March 2025

Type: label

Tier: primary

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75

### 3. DailyMed: Egrifta SV prescribing information, revised 2024

Type: label

Tier: primary

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224

### 4. FDA approval letter for Egrifta WR, supplement 020, 25 March 2025

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf

### 5. FDA: approved applications for biological products deemed to be licenses on 23 March 2020

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/119229/download

### 6. FDA guidance: mixing, diluting, or repackaging biological products outside the approved license, January 2018

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/90986/download

### 7. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026

### 8. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026

### 9. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026

### 10. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026

### 11. Alliance for Pharmacy Compounding: compounding peptides, a briefing for prescribers, August 2022

Type: legal-analysis

Tier: legal-analysis

Source: https://join.a4pc.org/hubfs/PDFs/2022-08-Prescriber-Briefing-Peptides_4-Aug-2022.pdf

### 12. Sheppard Mullin: FDA warning letters to unlawful peptide sellers, 2026

Type: legal-analysis

Tier: legal-analysis

Source: https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers

### 13. Tesamorelin for belly fat in adults with HIV, first large trial, 2007

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/18057338/

### 14. Tesamorelin in adults with HIV and belly fat, with a safety extension, 2010

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/20101189/

### 15. Tesamorelin and belly and liver fat in adults with HIV, 2014

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/25038357/

### 16. Tesamorelin and fatty liver disease in adults with HIV, 2019

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/31611038/

### 17. Review and meta-analysis: tesamorelin in people with HIV and lipodystrophy, 2026

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/42538058/

### 18. Meta-analysis: tesamorelin and body fat, liver fat and safety in HIV lipodystrophy, 2026

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/41545261/

### 19. The Pharma Letter: new Egrifta form approved, 26 March 2025

Type: reference

Tier: established-news

Source: https://thepharmaletter.com/theratechnologies-secures-fda-approval-for-new-formulation-of-tesamorelin

### 20. Contract Pharma: FDA approves Egrifta WR, 26 March 2025

Type: reference

Tier: established-news

Source: https://www.contractpharma.com/breaking-news/theratechnologies-receives-fda-approval-for-egrifta-wr/

### 21. FDA: 503A bulk drug substances under evaluation, Category 1 and Category 2 lists

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 22. FDA: bulk drug substances that may present significant safety risks, Category 2

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

### 23. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026

Last verified: 2026-10-25.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=tesamorelin+OR+Egrifta&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://pubmed.ncbi.nlm.nih.gov/18057338/
- https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026

[^1]: Drugs@FDA: Egrifta, biologic license application 022505 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
[^2]: DailyMed: Egrifta WR prescribing information, revised March 2025 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
[^3]: DailyMed: Egrifta SV prescribing information, revised 2024 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
[^4]: FDA approval letter for Egrifta WR, supplement 020, 25 March 2025 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf
[^5]: FDA: approved applications for biological products deemed to be licenses on 23 March 2020 https://www.fda.gov/media/119229/download
[^6]: FDA guidance: mixing, diluting, or repackaging biological products outside the approved license, January 2018 https://www.fda.gov/media/90986/download
[^7]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026
[^8]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026
[^9]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026
[^10]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026
[^11]: Alliance for Pharmacy Compounding: compounding peptides, a briefing for prescribers, August 2022 https://join.a4pc.org/hubfs/PDFs/2022-08-Prescriber-Briefing-Peptides_4-Aug-2022.pdf
[^12]: Sheppard Mullin: FDA warning letters to unlawful peptide sellers, 2026 https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers
[^13]: Tesamorelin for belly fat in adults with HIV, first large trial, 2007 https://pubmed.ncbi.nlm.nih.gov/18057338/
[^14]: Tesamorelin in adults with HIV and belly fat, with a safety extension, 2010 https://pubmed.ncbi.nlm.nih.gov/20101189/
[^15]: Tesamorelin and belly and liver fat in adults with HIV, 2014 https://pubmed.ncbi.nlm.nih.gov/25038357/
[^16]: Tesamorelin and fatty liver disease in adults with HIV, 2019 https://pubmed.ncbi.nlm.nih.gov/31611038/
[^17]: Review and meta-analysis: tesamorelin in people with HIV and lipodystrophy, 2026 https://pubmed.ncbi.nlm.nih.gov/42538058/
[^18]: Meta-analysis: tesamorelin and body fat, liver fat and safety in HIV lipodystrophy, 2026 https://pubmed.ncbi.nlm.nih.gov/41545261/
[^19]: The Pharma Letter: new Egrifta form approved, 26 March 2025 https://thepharmaletter.com/theratechnologies-secures-fda-approval-for-new-formulation-of-tesamorelin
[^20]: Contract Pharma: FDA approves Egrifta WR, 26 March 2025 https://www.contractpharma.com/breaking-news/theratechnologies-receives-fda-approval-for-egrifta-wr/
[^21]: FDA: 503A bulk drug substances under evaluation, Category 1 and Category 2 lists https://www.fda.gov/media/94155/download
[^22]: FDA: bulk drug substances that may present significant safety risks, Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[^23]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026