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Doseworth

FDA warning letter · #716696

FWD: What the FDA Letter Means for What You Pay

Legal name: FWD Care, Inc.

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/fwd-care-inc-dba-fwd-716696-09092025

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://fwd.care in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.

  1. 1

    The following claims concerning compounded semaglutide and tirzepatide products appear on your website:

  2. 2

    “Manage weight affordably with compounded GLP-1, the same active ingredients as Wegovy, Ozempic, Zepbound & Mounjaro” “Same active ingredient in Mounjaro and Zepbound” “Same active ingredient as Ozempic and Wegovy”

  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.

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 FWD still operating?

fwd.care returned a live storefront on 2026-08-09, titled "Compounded GLP-1 Medications Online | FWD", headlined "Get weight loss meds delivered." and carrying published monthly prices, so the site was transacting at that check.

What this means for what you pay

This is the one letter here where the sentence FDA objected to is the sentence a price shopper actually reads. "Manage weight affordably with compounded GLP-1, the same active ingredients as Wegovy, Ozempic, Zepbound & Mounjaro" is a price argument and a sameness argument welded together: the second half is what makes the first half feel like a bargain rather than a different purchase. FDA did not say the price was wrong or the medicine was unsafe — it said the sameness half overstates what has been approved. Which leaves the comparison you were invited to make, brand price versus this price, resting on a premise a regulator has disputed. That is worth knowing before you treat the gap between the two numbers as pure savings.

Has FWD 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 FWD 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.