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FDA warning letter · #716458

Intimate Rose: What the FDA Letter Means for What You Pay

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

September 2025

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/intimate-rose-716458-09092025

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.intimaterose.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.

  1. 1

    "Same active ingredient as Ozempic and Wegovy"

  2. 2

    "Same active ingredient as Mounjaro and Zepbound"

  3. 3

    Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA.

Process

How a warning letter proceeds

  1. 1

    Letter issued

    September 2025

  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 Intimate Rose still operating?

intimaterose.com returned a live retail storefront when we checked in August 2026, selling pelvic health devices and supplements and still running a weight-management line described as personalized GLP-1 treatment from licensed providers, with semaglutide and tirzepatide named on that page.

What this means for what you pay

A shopping site trains you to read a bulleted line under a product photo as a specification — the material, the size, the dosage — rather than as a claim someone is making. That habit is exactly what FDA pushed back on here. The two lines it quoted sit where a spec would sit, but "same active ingredient as Ozempic" is not a spec in the sense a compounded product can support: the molecule may be the same while the finished product has not been through the approval that gives the brand name its meaning. Where the site sells a kegel trainer and a prescription injection out of the same catalogue, that distinction is easy to lose. It does not make the price wrong, and the letter says nothing about the price. It means the reassurance printed above the price is doing more work than the product behind it has earned.

Has Intimate Rose 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 Intimate Rose failed to respond.

Sources

Other letters in this index

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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.