Warrior Labz SARMS: FDA Warning Letter Record (June 12, 2023)

Updated August 30, 2026

FDA issued warning letter 655280 to Warrior Labz SARMS of Agoura Hills, California on June 12, 2023, after reviewing the firm's website in May 2023. It is the earliest warning letter recorded in this index, and it matters for one reason: it is dated eighteen months before the December 2024 batch that most accounts treat as the start of research-peptide enforcement. Everything people describe as new in the 2024–2026 letters is already in this one — the research-use disclaimer overridden, a social media account read as evidence, a page of customer accounts counted as labeling, and the same signing office. The products named are not GLP-1-class compounds. Among them are "BPC-157" and "TB-500."

Record at a glance

Why the date is the point

Most published summaries of research-peptide enforcement begin with the four letters of December 10, 2024, and read the pattern as a reaction to the GLP-1 boom that later widened to other compounds. This letter does not fit that reading. It was signed in June 2023, and the same office signed it.

CAPT Tina Smith signed 655280 as Acting Director of the Office of Unapproved Drugs and Labeling Compliance. She signs the seven letters of March 31, 2026 as Director of the same office. The response address on this 2023 letter, FDAADVISORY@fda.hhs.gov, is the address on the later letters too. This is one continuing program, not a new one.

The compounds do not fit the reading either. A single letter covers four SARMs, two prohormones, two peptides, and two erectile-dysfunction drugs, all under one legal theory. The theory does not care what class the molecule belongs to. It asks what the seller's website said the product was for.

What FDA cited

The agency's core sentence appears early and applies to every product on the list:

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.

FDA then reproduced the website copy it read as establishing that intent. For the four SARMs and the two prohormones, the quoted material is a list of asserted effects on the body written directly to the reader, followed in most cases by usage instructions. The RAD-140 copy, for example, was quoted as claiming the product Carries the benefits of Testosterone injections without all the risks and Reduced androgenic effects on the prostate to cut the risk of growth of Prostate Cancer. The MK-677 copy was quoted as saying the product Treats deficiency in Growth Hormone. The LGD-4033 copy was quoted as saying it Treats Osteoporosis.

None of that is subtle, and none of it is in dispute here. A page that tells a reader a product acts on a named disease is the oldest and clearest form of intended-use evidence. It appears in nearly every letter in this index.

The BPC-157 citation

The copy FDA quoted for "BPC-157" is a disease-claim passage. The agency reproduced the firm's statement that the product acts systemically in the digestive tract to combat leaky gut, IBS, gastrointestinal cramps, and Crohn's disease, that it has been known to exhibit analgesic characteristics, and that research has shown its ability to help skin burns heal at a faster rate by increasing blood flow to damaged tissues.

Four named conditions and an asserted effect on each. Whatever else is true about the compound's published literature, that passage is written as a claim about what the product does for a person, and it is why the product entered the letter.

The TB-500 citation — and the confound in it

The "TB-500" citation is the one worth reading slowly, because it is the one most often misread.

Part of what FDA quoted is species-qualified preclinical reporting:

In animal models, Thymosin Beta-4 has been shown to improve blood vessel growth, regulate wound healing, decrease inflammation, and reduce oxidative damage in the heart and central nervous system.

On its face that sentence does what careful research writing is supposed to do. It names the model. It attributes the finding. It promises the reader nothing and does not address the reader at all.

But it cannot be read on its own, because FDA did not quote it on its own. The agency reproduced it as one continuous block together with the same product page's administration instructions. That second half is unambiguous. A page that tells a reader how much to take, how often, and by what route is not describing research.

So this letter is not clean evidence that animal-model reporting by itself draws a citation. The dosing text was sitting in the same block. Anyone citing 655280 for the proposition that preclinical framing alone is enough to draw FDA attention is citing more than the document supports. The Wholesale Peptide letter of June 17, 2026 is the record that speaks to that question, because there the research-register language was quoted without any dosing text beside it.

A note on what this page does not reproduce

This index does not republish usage instructions of any kind, including when they appear inside a primary document we are otherwise quoting in full. That material is described above, not reprinted, and the same applies to the equivalent lines in the SARMs copy and to the sildenafil and tadalafil timing instructions the letter also quotes.

The omission does not soften the record. The evidentiary point is that the instructions were present on the product pages and that FDA quoted them, and that point is stated plainly. Readers who need the exact wording can read the letter itself, which is linked in full below.

"Research purpose only," overridden in 2023

The firm's labeling carried a disclaimer. The letter deals with it in a single sentence:

Despite statements on your product labeling marketing your products for "research purpose only" and "not for human consumption," evidence obtained from your website establishes that your products are intended to be drugs for human use.

Two things about that sentence are worth noting.

First, the wording of the disclaimer is research purpose only — not the research use only formulation that is more common across this index. The agency's answer did not turn on the phrasing. It compared the disclaimer against the rest of the website and found the rest of the website heavier. A different arrangement of the same three words changed nothing.

Second, and more useful for dating the doctrine: the second half of that sentence is close to word-for-word what FDA writes in the March 2026 batch. The position this index elsewhere records from the 2024 and 2026 letters was already written, in this form, in June 2023.

Instagram and a customer-review page as evidence

The letter states that the agency reviewed the firm's Instagram account, which directs consumers to your website https://warriorlabzsarms.com/ to purchase your products. That sentence is the attribution hook — the reason a social account counts as the seller's own labeling — and it appears here in its finished form eighteen months before the December 2024 batch this index built its social-media record from.

What FDA quoted from the account is a July 6, 2022 post offering a bundle of six products for a flat price delivered anywhere in the USA, and listing the payment methods accepted: Zelle, Cash App, Venmo, Apple Pay and Pay Pal - Friends and Family. The post is quoted as part of the intended-use record.

The agency also quoted the firm's own customer-review page. The customer statement reproduced in the letter begins For almost 4 weeks now I have been using MK-677, RAD-140 and LGD-4033, The Warrior Mass Stack, and I feel amazing. A page of customer accounts describing personal use is, on this record, material the agency will read as evidence of what a product is intended for. This is the earliest instance of that in the index.

The route-of-administration footnotes

The letter attaches two safety footnotes, one for each delivery route among the cited products. The first is the standard paragraph that appears across this corpus: Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms.

The second footnote is the first of its kind recorded in this index, and it addresses the other delivery form in which the cited products were sold. FDA wrote: Intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.

Both footnotes reason about the route, not the molecule. Neither depends on which compound is in the container.

What does the evidence not show?

Five limits on what this record establishes.

1. A warning letter is not a court judgment. It states the agency's position and offers the recipient a chance to respond. Nothing in it has been adjudicated, and the letter says so itself: it is not intended to be an all-inclusive statement of violations.
2. The outcome is unknown, and a missing close-out letter tells you less than it seems to. No close-out letter for reference number 655280 was located when this entry was compiled. FDA's own description of the program explains why that is weak evidence either way. A close-out letter issues only after the agency has evaluated a firm's corrections and verified them: A close-out letter will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. More to the point for a letter of this kind, the agency also states that If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue. Silence in the record is not a finding.
3. This is the earliest letter in this index, not necessarily the earliest FDA issued. No systematic sweep of the agency's database for pre-2024 peptide letters has been completed for this record. Earlier ones may exist. The claim made here is bounded: the enforcement pattern was already complete in June 2023, which is enough to correct a 2024 start date without asserting a start date of our own.
4. The TB-500 citation is confounded, as set out above. It does not establish that preclinical, species-qualified reporting draws a citation on its own.
5. This letter carries no misbranding count, unlike several of the 2025 and 2026 letters. Reading it as identical to the later letters overstates the similarity. The unapproved-new-drug theory is the same; the charging pattern is not.

How to read this record

The practical value of an early letter is that it settles a question about timing. If a seller, a buyer, or a writer explains the current enforcement picture as a response to the GLP-1 category boom, this document is the counter-example: the same office, the same statutory theory, the same handling of disclaimers and social accounts and customer reviews, applied in mid-2023 to a catalog that included peptides, SARMs, prohormones, and erectile-dysfunction drugs together.

For anyone reading vendor pages today, the transferable observation is narrow. The material FDA quoted in 2023 was not hidden. It was the product description, the usage line, the customer-review page, and the storefront's own Instagram — the four most visible surfaces a seller has. The letter is a record of what the agency read, on what date, and what it concluded from it, and all of it was in public view.

Sources

1. US FDA — Warning Letter, Warrior Labz SARMS, reference number 655280, June 12, 2023. fda.gov/…/warrior-labz-sarms-655280-06122023 — every quotation on this page is taken verbatim from this document.
2. US FDA — Warning Letters index (searchable). fda.gov/…/compliance-actions-and-activities/warning-letters
3. US FDA — About Warning and Close-Out Letters (what a warning letter is, and the close-out letter program). fda.gov/…/about-warning-and-close-out-letters

Further reading

1. The enforcement chronology — where the later letters sit in sequence.
2. The research-use-only disclaimer in the enforcement record — the doctrine this letter dates to 2023.
3. Wholesale Peptide, June 17 2026 — the record where research-register language was cited without dosing text beside it.
4. Reposted customer reviews as intended-use evidence.
5. The SARMs regulatory record — FDA's published position on the compound class this letter's title names.
6. Full vendor index — every entity record.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.