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Doseworth

FDA warning letter · #721474

Premium Health: What the FDA Letter Means for What You Pay

Legal name: Premium Health Management Inc.

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

February 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/premium-health-management-inc-dba-premium-health-721474-02202026

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://premiumhealth.us, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products.

  1. 1

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

  2. 2

    Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website: “generic compounded medication” “Semaglutide (the active ingredient used in Ozempic® and Wegovy®)” “Tirzepatide (active ingredient used in Mounjaro®)”

  3. 3

    The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.

Process

How a warning letter proceeds

  1. 1

    Letter issued

    February 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 Premium Health still operating?

premiumhealth.us returned a live site on 2026-08-09 titled "Premium Health - Personalized Healthcare Solutions", with navigation to a "Semaglutide Weight Loss Program" and a "Tirzepatide Weight Loss Program" alongside a bookable IV-therapy menu carrying posted prices from $279 to $449 per treatment. No GLP-1 program price is published on the landing page.

What this means for what you pay

The phrase to sit with is "generic compounded medication", because it is doing something the other quoted claims are not. The brand comparisons at least tell you what they are comparing to; this one is a standalone label, and it borrows the whole meaning of the word "generic" without naming anything. In US drug regulation a generic is a specific thing — an FDA-approved copy that has been shown equivalent to a reference product and can be substituted for it. A compounded preparation has not been through that. Calling it generic in the abstract is therefore the cheapest possible way to import a guarantee, because there is no comparison on the page for a reader to check. Set against that, the second quoted line is unusually restrained: it names Mounjaro and stops, where nearly every seller in this wave named Mounjaro and Zepbound together. None of this is a finding about the drug. It is a finding that the words most likely to make a lower price look like a straightforward saving were not accurate as written, and the shortest of them was the least accurate.

Has Premium Health 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 Premium Health 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.