Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 719337 to Pinnacle Professional Research dba Pinnacle Peptides
Issued December 12, 2025. The letter alleges that the products marketed as selective androgen receptor modulators on pinnaclepeptides.com are unapproved new drugs intended for human use, despite research-only labeling. It asks for a written response and it did not halt the business. The ledger record for Pinnacle Peptides passes S8.
The letter, as filed
Every line below is copied from the letter itself. The addressee and the address are the ones the agency prints in the header, which is the pair an attribution rests on.
| Number | MARCS-CMS 719337 |
|---|---|
| Issued | December 12, 2025 |
| Addressee | Pinnacle Professional Research dba Pinnacle Peptides |
| Address | 1001 N Elm Street, Suite 31, Greensboro, NC 27401 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Unapproved New Drugs |
| Website reviewed | https://www.pinnaclepeptides.com, reviewed in November 2025 |
| Sections cited | 201(g)(1), 201(p), 301(d), 505(a) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when the close-out column was last read. |
What it alleges
The products marketed as selective androgen receptor modulators on pinnaclepeptides.com are unapproved new drugs intended for human use, despite research-only labeling.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“Andarine . . . is a non-steroidal selective androgen receptor modulator (SARM) . . . anabolic activity is similar to that of testosterone’s . . . for musculoskeletal disorders and benign prostatic hyperplasia [and] found to improve fertility and sexual health in men and women.”
“LGD-4033 . . . belongs to the class selective androgen receptor modulator (SARM). . . . [I]t exerts anabolic effects on muscles and bones without causing side effects associated with steroids.”
A quoted claim is evidence of what a page said when the agency read it. It is not evidence of what the page says today, and this site records the seller's current pages separately, on the seller record, with their own date.
The sections cited are 201(g)(1), 201(p), 301(d), 505(a). Section 505(a) prohibits introducing an unapproved new drug into interstate commerce and section 301(d) makes doing so a prohibited act. That is an unapproved-drug allegation rather than a labeling one.
How it was attributed
The letter reviews pinnaclepeptides.com by name, quotes three of its product pages by URL, and prints the support address the site itself publishes in its own footer. A letter is filed under an operating entity, and a company may trade under names that appear nowhere in it, so the screen is run against the entity and the address rather than against the brand on the storefront. A name resemblance is never the test, because attaching one company's enforcement record to another is a worse error than missing a disclosure.
What the ledger records since
Pinnacle Peptides is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 719337, December 2025, names Pinnacle Professional Research doing business as Pinnacle Peptides and alleges its products marketed as selective androgen receptor modulators are unapproved new drugs. No FDA action has halted the business, and the seller still trades. The storefront was reachable and trading when the record was last read.
The index carries no close-out letter for it. When the index was read in September 2026 it held 3,677 letters and 417 of them carried a close-out letter, so the column is populated and an empty cell is a reading rather than a gap. A letter that has been neither closed out nor followed by an action is the ordinary state of a warning letter.
Why this is not a disqualification
A warning letter identifies a concern, requests a response, and states that failure to address the violations may result in legal action, including seizure and injunction. Those actions are what criterion S8 fails on. The letter is the notice that precedes them and it is not one of them, so this ledger records it in full, dates it, links it, and leaves the seller listed and linked exactly as a seller with no letter.
Sources
- FDA warning letter 719337 to Pinnacle Professional Research dba Pinnacle Peptides, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
- The seller record this letter is disclosed on
The letter was fetched from fda.gov and read in full on the date in the meta line above, in a run where every letter this ledger discloses returned a document and a fabricated letter address returned nothing, by the same method. This page ranks nothing, recommends nothing, and carries no partner link.