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FDA warning letter · #716501

Zealthy: What the FDA Letter Means for What You Pay

Legal name: FitRX, LLC

Activesemaglutide
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/fitrx-llc-dba-zealthy-716501-09092025

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.getzealthy.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.

  1. 1

    "Is Semaglutide the same as Wegovy and Ozempic? Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective..."

  2. 2

    "Semaglutide is the active ingredient in Wegovy and Ozempic. Semaglutide is often more cost effective for Zealthy members whose insurance deny coverage of brand name medication like Wegovy or who are uninsured."

  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 Zealthy still operating?

getzealthy.com returned a live, fully functional storefront when we checked in August 2026, running a promotional offer on its weight-loss program and still listing weight loss alongside primary care, hair loss and skincare.

What this means for what you pay

Most letters in this roster quote a company's efficacy copy. This one quotes its pricing copy, which makes it the clearest illustration of the distinction a price shopper needs: FDA did not say the compounded product costs more than advertised, and it did not dispute that compounded semaglutide is cheaper than brand-name Wegovy — that part is ordinarily true. What it objected to was the sentence attached to the price, which framed the cheaper product as interchangeable with the approved one. When you see a savings figure quoted against Ozempic or Wegovy, the saving is real; the equivalence implied by the comparison is what FDA said is not established.

Has Zealthy 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 Zealthy 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.