FDA FILEDOCUMENTED

FDA warning letter to Pinnacle Peptides names three SARMs products sold as research-only

Short answer · as of 2026-10-05

DOCUMENTED. FDA posted a warning letter on Dec. 23, 2025 (dated Dec. 12) to Pinnacle Professional Research dba Pinnacle Peptides of Greensboro, NC, saying its SARMs products are unapproved new drugs. The letter is FDA's allegation; the firm had 15 working days to respond.

Attribution: Compiled from the warning letter as posted on FDA's website, read on October 5, 2026. We have not seen a company response. This is an archive entry added after publication of the later 2026 letters.

Allegations in government documents and in reports by others are theirs, not findings by us. Verify against the linked sources. Disclaimer.

By Peptide Industry Gossip · Observed · Published

1 letter
Dated Dec. 12, 2025 and posted Dec. 23, 2025, signed by the director of CDER's Office of Unapproved Drugs and Labeling Compliance
3 products
S4 Andarine, LGD-4033 and MK-2866, which the letter discusses as SARMs
505(a)
FD&C Act section cited for selling unapproved new drugs, with 301(d), 201(g)(1) and 201(p)
15 days
Working days the firm was given to respond in writing
What is and is not supported
SUPPORTED
FDA issued a warning letter to Pinnacle Professional Research dba Pinnacle Peptides in December 2025
Letter MARCS-CMS 719337, Greensboro, NC.
FDA ALLEGES
The products are unapproved new drugs
The letter cites sections 505(a) and 301(d) of the FD&C Act and the drug definitions in sections 201(g)(1) and 201(p). These are FDA's findings, not a court ruling.
NONE LOCATED
The firm responded publicly or changed its listings
We did not search beyond the FDA page.

What happened

  • On Dec. 23, 2025, FDA posted a warning letter dated Dec. 12, 2025 to Pinnacle Professional Research dba Pinnacle Peptides, Greensboro, NC.
  • The letter says FDA reviewed the firm's website in November 2025 and names S4 Andarine, LGD-4033 and MK-2866. The products' labeling or listings carried wording such as “for research only” and “not for human use.”
  • FDA says the website's claims establish the products are intended as drugs. It describes claims about muscle growth, bone loss and osteoporosis, fracture healing, certain cancers and diabetes, and says the research-only wording does not change that.
  • The letter gave the firm 15 working days from receipt to describe the steps it had taken to correct the violations.

What we can verify

  • FDA posted the letter on Dec. 23, 2025; it remained on FDA's site when we read it on Oct. 5, 2026.
  • The letter cites sections 201(g)(1), 201(p), 301(d) and 505(a) of the FD&C Act and the 15-working-day response window.

What remains unknown

  • Whether the firm responded, removed the listed products, or faced further action.
  • Whether the site is still operating; we did not check it.

Timeline

Date / timeEvent
2025-12-12FDA issues a warning letter to Pinnacle Professional Research dba Pinnacle Peptides (Greensboro, NC).
2025-12-23FDA posts the letter. It gives the firm 15 working days from receipt to respond.

Receipts

Company response

No company response located as of the publish date.

Why people care

The firm's name says peptides, but the products the letter names are SARMs. Match the products named in a letter to the story you are reading, not just the company name. The letter also shows FDA applying its research-only reasoning beyond peptide products.

New to warning letters? Does an FDA warning letter mean a company is shut down?

Corrections and update log

No corrections or updates. Request a correction.

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