Sermorelin
Also sold as: Sermorelin acetate, GEREF, Geref Diagnostic, GHRH(1-29)NH2, GRF(1-29)NH2
Sermorelin is not an FDA-approved drug: FDA withdrew approval of both GEREF (sermorelin acetate) new drug applications effective 18 June 2009 at the sponsor EMD Serono's own request, and Drugs@FDA records every sermorelin product it lists as discontinued. The approval sermorelin once held was for the treatment of idiopathic growth hormone deficiency in children with growth failure — not for the muscle-growth and fat-loss uses it is sold for now, which FDA has never evaluated and which it cited as unapproved-new-drug violations in a December 2024 warning letter. FDA's 2013 determination that GEREF was 'not withdrawn from sale for reasons of safety or effectiveness' is a narrow administrative finding whose stated purpose is to let generic applications reference the discontinued drug; it is not a safety clearance and not a current approval.
Which molecule this is. Sermorelin is the synthetic, amidated 1-29 fragment of endogenous human growth hormone-releasing hormone (GHRH, 44 amino acids) — the shortest fragment retaining full GH-releasing activity. It is a SECRETAGOGUE: it stimulates the pituitary to release the body's own growth hormone, and is not growth hormone itself. Do not conflate it with full-length GHRH, with tesamorelin (a stabilised GHRH analogue approved for a different indication entirely — HIV-associated lipodystrophy), or with CJC-1295 and other long-acting GHRH analogues that have no approval of any kind. Vendor copy frequently treats these as interchangeable; FDA's approvals do not.
FDA status
FDA approved this once and has since withdrawn the approval. No approved product is on the market. A withdrawal made at the sponsor's request, and not for reasons of safety or effectiveness, is not an endorsement — it is the absence of one.
Approved once; FDA has since withdrawn the approval. No approved product is marketed. This is not a safety finding, and it is emphatically not an endorsement.
Evidence
Efficacy established by adequate, well-controlled trials in humans.
WHY THIS SOURCE AND NOT THE PIVOTAL ONE: 'proven-in-humans' is defined as efficacy established by adequate, WELL-CONTROLLED trials, so the tier is keyed to the randomised trial (PMID 8329826), not to the larger Geref International Study Group publication (PMID 8772599), which is OPEN-LABEL AND UNCONTROLLED and cannot carry that bar on its own. The randomised trial assigned 43 prepubertal children (mean age 10.4 +/- 2.9 yr) to two GHRH(1-29)NH2 regimens or to growth hormone; researchers reported a height-velocity increase of 2 cm/yr or more in all but two children, comparable height velocity in the high-dose GHRH and GH arms, but an increase in height SDS for bone age in the GH arm ONLY. It is small, six months long, and published in a supplement — the tier rests on it TOGETHER WITH FDA's approval of NDA 20-443 for this indication, not on it alone. ADMINISTRATION CHECK: passed, and unusually so for this library. Unlike MOTS-c and TB-500 — whose apparent human trials all turn out to measure the ENDOGENOUS peptide as a biomarker — sermorelin was genuinely administered to human subjects in both trials. The supporting pivotal programme publication (Geref International Study Group, J Clin Endocrinol Metab 1996;81(3):1189-96, PMID 8772599, https://pubmed.ncbi.nlm.nih.gov/8772599/ — n=110 previously untreated prepubertal GH-deficient children, 86 eligible for efficacy analysis) administered once-daily subcutaneous sermorelin for up to one year; researchers reported mean height velocity rose from 4.1 +/- 0.9 cm/yr at baseline to 7.2 +/- 1.3 cm/yr at 12 months, and characterised the drug as well tolerated — but reported it without a control arm. THE TIER IS SCOPED TO ONE INDICATION AND DOES NOT TRAVEL: 'proven-in-humans' here means FDA found substantial evidence of effectiveness for GROWTH FAILURE IN CHILDREN WITH IDIOPATHIC GH DEFICIENCY, and nothing else. Limitations, stated plainly: only 74% of children were rated good responders at 6 months in the pivotal study. The non-response is not a footnote — in a follow-up cohort (PMID 11572326), 27 children who had withdrawn from Geref (25 of them for inadequate height velocity, one for injection site reactions) went on to respond excellently to recombinant growth hormone; in another multicentre study (PMID 7735367), 31.3% were poor responders and were switched to recombinant hGH. The pattern across these reports is that a secretagogue depends on a pituitary that can still answer, and in a meaningful minority of these children the investigators reported that it did not. FOR THE MARKETED USE THERE IS NO SUCH EVIDENCE: we searched PubMed on 2026-07-16 for sermorelin administered to healthy adults for aging, body composition or longevity endpoints and found no adequate and well-controlled trial. What that search returns is a narrative review, an editorial, and animal studies of GHRH ANTAGONISTS — a different class of molecule with the opposite pharmacology. FDA never evaluated sermorelin for any adult anti-aging use.
What FDA actually approved
- Application
- NDA 020443 — GEREF (discontinued)
- Approved indication
- indicated for the treatment of idiopathic growth hormone deficiency (GHD) in children with growth failure
- On the discontinuation
- Discontinued, and explicitly NOT for safety or efficacy reasons — but read what that determination actually says before it gets recycled as an endorsement. EMD Serono notified FDA by letter dated 2008-12-02 that GEREF injection (0.5 mg base/vial and 1.0 mg base/vial) was being discontinued and requested withdrawal of NDA 20-443; FDA withdrew approval effective 2009-06-18. Responding to a citizen petition (Docket No. FDA-2012-P-1071), FDA determined under 21 CFR 314.161 that the product 'w[as] not withdrawn for reasons of safety or effectiveness', having reviewed its own files and independently evaluated relevant literature and postmarketing adverse event data. The product stays on the Orange Book's Discontinued Drug Product List, which 'delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness'. THE PURPOSE of that determination is narrow and administrative: it lets FDA approve ANDAs referencing GEREF. It is a finding about why a company stopped selling a drug — a commercial decision — NOT a safety clearance, NOT a current approval, and NOT any statement that sermorelin works for aging, body composition or 'GH optimisation'. Marketing that cites this determination as proof sermorelin is 'FDA-vetted and safe' is inverting it.
THERE WERE TWO GEREF NDAs WITH DIFFERENT INDICATIONS, AND THEY ARE ROUTINELY CONFLATED — including in the research lead that produced this record, which described both as paediatric GHD treatment. The Federal Register notice is explicit that they differ: NDA 20-443 (0.5 and 1.0 mg base/vial, approved 1997-09-26) is the TREATMENT approval recorded above, while NDA 19-863 (0.05 mg base/amp, approved 1990-12-28) is a DIAGNOSTIC agent — verbatim, it is 'indicated for evaluating the ability of the somatotroph of the pituitary gland to secrete growth hormone'. A diagnostic approval is a finding that a substance is useful for MEASURING pituitary function for a couple of hours, not for treating anything. Both approvals were withdrawn effective 2009-06-18. This record keys on NDA 20-443 because the treatment approval is the one the anti-aging market implicitly invokes; citing '2 FDA approvals' as if both were therapeutic doubles the error.
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA withdrew approval of both GEREF (sermorelin acetate) new drug applications effective June 18, 2009, acting on EMD Serono's own written request after the company informed FDA the products were no longer marketed and waived its opportunity for a hearing.
THIS IS THE DOCUMENT THAT ENDED THE APPROVAL, and it is the one the market never reads — which is why 'sermorelin is an FDA-approved peptide' survives in 2026. The operative sentence is unambiguous: under section 505(e) of the FD&C Act, 'approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 18, 2009.' Note what the quoted passage establishes and what it does not. The withdrawal was APPLICANT-INITIATED — a company electing to stop marketing a drug and asking FDA to close the file — so it is not a safety action, and this record does not present it as one. But 'not a safety action' does not soften the legal consequence: a withdrawn approval is not a dormant approval. There is no approved application in effect, and there has not been since 2009.
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications (74 FR 23407, FR Doc. E9-11628) — Federal Register, 19 May 2009“The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing.”
Checked against the source on .FDA stated in December 2024 that no FDA-approved application under section 505 is in effect for the sermorelin product it reviewed.
The single most useful sentence in this record for the question people actually ask. It is FDA, in the present tense, in 2024 — fifteen years after the withdrawal and eleven after the 2013 determination — confirming that no approval is in effect for a sermorelin product being sold. Anyone can claim the 2009 withdrawal left some residue of approval behind; this is FDA saying it did not. The sentence is scoped to the seven products in this letter, SERMORELIN among them, and we do not stretch it further than that.
Warning Letter — Xcel Research LLC (694608) — FDA, 10 December 2024“No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products.”
Checked against the source on .FDA held that 'FOR RESEARCH USE ONLY' and 'NOT INTENDED FOR HUMAN USE' labelling did not prevent a sermorelin product from being a drug intended for human use, because the seller's own website content established the human intended use.
Recorded verbatim because this is a FAILED legal theory, and it is reproduced here as a failed one. The disclaimer is the load-bearing element of nearly every research-peptide storefront selling sermorelin, and FDA disposed of it in one sentence: intended use is established by the evidence, and the seller's own marketing copy is that evidence. What the disclaimer bought Xcel Research was nothing at all.
Warning Letter — Xcel Research LLC (694608) — FDA, 10 December 2024“Despite statements on your product labeling marketing your products, “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE,” evidence obtained from your website establishes that your products are intended to be drugs for human use.”
Checked against the source on .FDA found that sermorelin offered for sale online is an unapproved new drug, and that a 'FOR RESEARCH USE ONLY / NOT INTENDED FOR HUMAN USE' label does not cure the violation where site content establishes human intended use.
READ THE QUOTE AGAIN — IT IS THE VIOLATION, NOT THE DEFENCE. FDA reviewed xcelpeptides.com in October 2024 and reproduced all three of those bullets — verbatim, in the letter, under the heading '“SERMORELIN”' — as the evidence of intended use. THOSE THREE ARE THE COMPLETE SET: metabolism and weight loss, muscle growth and repair, metabolism and fat loss. FDA cited NO anti-aging claim for sermorelin in this letter; the words 'aging' and 'anti-aging' appear nowhere in it (we searched the full text on 2026-07-16 — the only hits are inside the word 'managing'). Sermorelin is marketed for anti-aging elsewhere, and this record says so in prose, but THIS letter is not the source for that and must not be cited as if it were. Note how carefully hedged the vendor copy is — 'studied in clinical trials', 'is believed to', 'in subjects', 'potential benefits'. The literature-review voice, the passive framing and the research-only disclaimer bought nothing: FDA held the products 'are not generally recognized as safe and effective for the above referenced uses and, therefore, are "new drugs" under section 201(p)', unlawful to introduce into interstate commerce under sections 505(a) and 301(d). BE PRECISE ABOUT WHAT THIS LETTER DOES NOT SAY: it makes no misbranding charge. We searched the full text on 2026-07-16 — 'misbrand', '502(f)' and 'adequate directions for use' each appear zero times, and the conclusion recites only 301(d) and 505(a). The charge is unapproved new drug, and nothing more. Sermorelin was cited alongside retatrutide, cagrilintide, mazdutide, semaglutide and survodutide in the same letter. This is also why the citations in the evidence field above are attributed to STUDIES and RESEARCHERS, never framed as what sermorelin can do for a reader.
Warning Letter — Xcel Research LLC (694608) — FDA, 10 December 2024“Sermorelin, a peptide studied in clinical trials, is believed to enhance the release of growth hormone in subjects. This heightened growth hormone production is associated with potential benefits, including improved metabolism and the facilitation of weight loss. ... Enhanced Muscle Growth and Repair[.] One of the primary benefits observed in test subjects administered with sermorelin is enhanced muscle growth and repair. ... Improved Metabolism and Fat Loss[.] Another notable benefit of sermorelin is its potential to improve metabolism and aid in fat loss.”
Checked against the source on .Sermorelin does not appear in Category 1, Category 2 or Category 3 of FDA's 503A bulk drug substances nomination list as updated 2026-05-14.
Recorded as an observation, not a conclusion. Category 2 on that list contains exactly six substances — Cesium Chloride, Domperidone, Germanium Sesquioxide, Ibutamoren Mesylate, Kisspeptin-10, and Quinacrine Hydrochloride for intrauterine administration — and sermorelin is not among them, nor in Categories 1 or 3. Absence from this list is NOT a permission and NOT a safety finding, and it is a different situation from the withdrawn nominations (BPC-157, TB-500, semax and the rest). Any claim that sermorelin is 'compoundable' or 'exempt' requires an affirmative statutory basis that this record does not assert, because none of the primary documents we read establishes one.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .FDA stated that the purpose of its 2013 'not withdrawn for safety or effectiveness' determination for GEREF is to allow abbreviated new drug applications referencing GEREF to be approved.
FDA STATING THE PURPOSE OF ITS OWN DETERMINATION, IN ITS OWN WORDS, IN THE SUMMARY PARAGRAPH — which is why this quote is worth more than any amount of our explaining. The determination is a generic-entry mechanism. It exists so that a would-be ANDA applicant has a listed drug to reference, and 21 CFR 314.161 requires FDA to make the finding before any such ANDA can be approved. That is the whole of it. It is not a review of sermorelin's safety in adults, not a re-approval, not an endorsement, and not a statement about any product sold today. Marketing that presents 'FDA determined sermorelin was not withdrawn for safety reasons' as a safety credential is quoting a procedural step in a generic-drug pathway and calling it a clean bill of health. Note also the condition FDA attaches even to that narrow purpose: 'if all other legal and regulatory requirements are met' — the determination clears one procedural obstacle, it does not approve anything. WHETHER ANY ANDA EVER FOLLOWED is answered by Drugs@FDA itself, and the answer is that the generic entry this determination was designed to enable does not appear to have happened: the database lists exactly two sermorelin applications, both of them the original EMD Serono NDAs, and no ANDA (see the Drugs@FDA finding below).
Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (78 FR 14095, Docket No. FDA-2012-P-1071) — Federal Register, 4 March 2013“This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, if all other legal and regulatory requirements are met.”
Checked against the source on .Drugs@FDA lists exactly two applications containing sermorelin acetate — NDA 019863 and NDA 020443, both held by EMD Serono — and records every product under both as Discontinued. No abbreviated new drug application containing sermorelin acetate appears.
THE AFFIRMATIVE VERSION OF THE CLAIM EVERYONE MAKES BY INFERENCE. 'No approved sermorelin is sold in the US' is usually asserted from a failed search, which proves nothing. This is the database saying it: sermorelin IS listed, the listings ARE the two GEREF NDAs, and every product under both reads Discontinued. Nothing here rests on something not being found. READ THE MARKETING STATUS PRECISELY: 'Discontinued' is Drugs@FDA's marketing-status vocabulary and it describes the PRODUCT, not the application. It is the withdrawal notice (fdaFindings[0]) that ended the approvals and the December 2024 warning letter (fdaFindings[1]) that states no section 505 application is in effect — this finding corroborates those two, it does not carry the legal conclusion by itself. ON THE ANDA QUESTION: the query is by ACTIVE INGREDIENT, not by brand, so a generic sermorelin would be returned by it. Two records come back and both are NDAs. That is a real answer to the question fdaFindings[4] raises — the 2013 determination exists to let ANDAs reference GEREF, and thirteen years on, none appears to have. SCOPE, HONESTLY: Drugs@FDA covers FDA-approved applications. It says nothing whatever about the unapproved research-peptide market, where sermorelin is actually sold — that product was never in this database and its absence from it is not a finding about it.
Drugs@FDA — applications containing SERMORELIN ACETATE (openFDA drug/drugsfda endpoint, 2 results: NDA019863, NDA020443) — FDA, 15 July 2026“"application_number": "NDA019863", "sponsor_name": "EMD SERONO" ... "brand_name": "GEREF", "marketing_status": "Discontinued" ... "application_number": "NDA020443", "sponsor_name": "EMD SERONO INC" ... "brand_name": "GEREF", "marketing_status": "Discontinued"”
Checked against the source on .FDA recorded that the citizen petitioner identified no data or other information suggesting either GEREF product was withdrawn for reasons of safety or effectiveness.
Kept because it shows the SHAPE of the determination, which is the thing most often misread. FDA is describing an absence in a petition record, and the petition was filed by Alvin J. Lorman on 2012-10-12 (Docket No. FDA-2012-P-1071) asking FDA to make exactly this finding — the posture is a party seeking a generic-entry ruling and FDA agreeing nobody produced contrary evidence. An absence of adverse data in a 2012 petition about a drug that left the US market in 2009 is a thin thing to build a safety claim on, and the determination never claims otherwise. FDA did also review its own files and the literature independently (see safetySignals) — but the standard it applied throughout is 'was this withdrawn FOR safety reasons', not 'is this safe'. Those are different questions and only the first one was asked.
Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (78 FR 14095, Docket No. FDA-2012-P-1071) — Federal Register, 4 March 2013“The petitioner has identified no data or other information suggesting that GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were withdrawn for reasons of safety or effectiveness.”
Checked against the source on .
Documented safety signals
Injection site reactions occurred in the Geref paediatric programme and were sufficient to cause at least one child to withdraw from treatment.
Reported among 27 children who left a Geref trial — 25 withdrew for inadequate height velocity, one at the onset of puberty, and one for injection site reactions. Scope honestly: this is a small tolerability signal from a paediatric GHD population studied for months to a couple of years. It says nothing about the safety of unapproved research-grade sermorelin, of unknown identity and purity, self-administered by adults indefinitely — a setting for which we found no controlled safety data at all.
Outcome of growth hormone therapy in children with growth hormone deficiency showing an inadequate response to growth hormone-releasing hormone. Endocrine 2001 — PubMed, 1 August 2001Checked against the source on .FDA reviewed its files and independently evaluated relevant literature and possible postmarketing adverse events for both GEREF products, and identified no safety or effectiveness basis for their withdrawal from sale.
The absence of a signal is not the presence of safety, and this is the sentence most likely to be quoted out of context. FDA's review was bounded by what GEREF actually was: a prescription drug, manufactured to NDA standards, used in children with diagnosed GH deficiency under medical supervision, and off the US market since 2009. It was not an evaluation of long-term adult use, of anti-aging use, or of any product sold today. A favourable 2013 determination about a discontinued brand-name drug says nothing about a product that is not that drug.
Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (78 FR 14095, Docket No. FDA-2012-P-1071) — Federal Register, 4 March 2013“We have also independently evaluated relevant literature and data for possible postmarketing adverse events for both GEREF products. We have reviewed the available evidence and determined that both GEREF products were not withdrawn from sale for reasons of safety or effectiveness.”
Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is sermorelin FDA-approved?
No. Sermorelin was approved, and is not now. FDA approved two GEREF (sermorelin acetate) new drug applications held by EMD Serono — NDA 19-863 on 28 December 1990 and NDA 20-443 on 26 September 1997 — and withdrew approval of both effective 18 June 2009, after EMD Serono informed FDA the products were no longer marketed and requested the withdrawal itself. In FDA's operative words, 'approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 18, 2009.' No FDA-approved sermorelin product has been marketed in the United States since. FDA confirmed the point again in a December 2024 warning letter about a sermorelin product offered for sale online, stating that no FDA-approved applications under section 505 are in effect for those products. A drug that was approved in the past is not an approved drug.
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications (74 FR 23407, FR Doc. E9-11628) — Federal Register, 19 May 2009“approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 18, 2009.”
Checked against the source on .- Does 'not withdrawn for reasons of safety or effectiveness' mean FDA found sermorelin safe?
No. That phrase is a finding about why a company stopped selling a drug, not a finding that the drug is safe, and FDA states its purpose plainly in the same notice: 'This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection... if all other legal and regulatory requirements are met.' It is a generic-entry mechanism. Under 21 CFR 314.161 FDA must decide whether a discontinued drug left the market for safety or effectiveness reasons before it can approve any generic referencing it, and in 2013, responding to a citizen petition, FDA determined GEREF had not. That determination was bounded by what GEREF was: a prescription drug made to NDA standards, given to children with diagnosed growth hormone deficiency under medical supervision, and off the US market since 2009. It evaluated no adult use, no anti-aging use, and no product sold today, and it did not restore the approval, which remains withdrawn.
Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (78 FR 14095, Docket No. FDA-2012-P-1071) — Federal Register, 4 March 2013“This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, if all other legal and regulatory requirements are met.”
Checked against the source on .- Is there any human evidence that sermorelin works for anti-aging or building muscle?
No adequate and well-controlled trial supports those uses, and FDA has never evaluated sermorelin for any of them. The human evidence for sermorelin is real but is confined to one population: children. FDA's approval of NDA 20-443 was for 'the treatment of idiopathic growth hormone deficiency (GHD) in children with growth failure', and the trials behind it enrolled prepubertal growth-hormone-deficient children and measured height velocity. A PubMed search on 16 July 2026 for sermorelin administered to healthy adults for aging, body-composition or longevity endpoints returned no adequate and well-controlled trial. When FDA reviewed a seller marketing sermorelin in October 2024 for 'enhanced muscle growth and repair' and 'improved metabolism and fat loss', it concluded the products 'are not generally recognized as safe and effective for the above referenced uses'. Evidence that a secretagogue raises growth hormone in children with a diagnosed deficiency is not evidence that it does anything for a healthy adult.
Warning Letter — Xcel Research LLC (694608) — FDA, 10 December 2024“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).”
Checked against the source on .- Is it legal to buy sermorelin online in 2026?
No. FDA has stated that sermorelin offered for sale online is an unapproved new drug whose introduction into interstate commerce is unlawful. In a warning letter dated 10 December 2024, FDA told Xcel Research LLC that its SERMORELIN product, alongside retatrutide, cagrilintide, mazdutide, semaglutide and survodutide, comprised '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, and that no FDA-approved applications under section 505 are in effect for them. Labelling the vial 'FOR RESEARCH USE ONLY' and 'NOT INTENDED FOR HUMAN USE' did not change that result: FDA held that evidence from the seller's own website established the products were intended to be drugs for human use, regardless of the disclaimer. FDA's charge in that letter was the unapproved new drug violation; it brought no misbranding charge.
Warning Letter — Xcel Research LLC (694608) — FDA, 10 December 2024“your “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN,” 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).”
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