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FDA warning letter · #728280

FITISH: What the FDA Letter Means for What You Pay

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

June 2026

Response logged

Not logged

By Marla Whitfield, Pricing Editor

Primary source

Read the original letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

Violations were identified and documented during a review of FITISH’s website, https://fitish.com, FDA Establishment Identifier (FEI) 3044018836, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.

  1. 1

    The compounded semaglutide and tirzepatide products displayed on your website identify “FITISH” on the pictured label, suggesting FITISH is the compounder of those drugs when in fact it is not.

  2. 2

    “Semaglutide is the active ingredient in ozempic” [sic]

  3. 3

    “Tirzepatide is the active ingredient in Mounjaro® and Zepbound®”

  4. 4

    Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

Process

How a warning letter proceeds

  1. 1

    Letter issued

    June 2026

  2. 2

    15-working-day response window

    FDA gives the company 15 working days to respond in writing.

  3. 3

    Close-out, if issued

    FDA may post one once it is satisfied the cited issues have been corrected.

Is FITISH still operating?

fitish.com returned a live storefront when we checked in August 2026, selling compounded semaglutide and tirzepatide, oral tirzepatide tablets, GLP-1 microdosing, NAD+ and sermorelin alongside a beauty and merchandise range. We did not review every page on the site.

What this means for what you pay

The [sic] is FDA's, and it tells you how these letters are built. Nobody rewrote the sentence, softened it or summarised it — an agency lawyer copied a lowercase line out of a product description and put it in a federal letter with a note that the error was the company's. That is worth knowing before you read any page in this collection, because it sets the scale. These are not investigations into how medicines were made. They are readings of website copy, sometimes a slogan, sometimes a fragment, occasionally a typo. A letter can therefore land on a company that is doing very little wrong in ordinary terms, and a company with no letter is not thereby endorsed — it may simply have written more careful sentences. Use the letter for what it reliably shows: on the date FDA looked, this page claimed an approval the compounded product did not have. Judge the price on its own.

Has FITISH responded?

As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence FITISH failed to respond.

Sources

Other letters in this index

View the full index →

Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.