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FDA warning letter · #728286

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

Legal name: Momentum Health 360

Activesemaglutidetirzepatideliraglutide
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/momentum-health-360-dba-momentum-health-728286-06082026

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

Violations were identified and documented during a review of Momentum Health's website, https://momentumhealth360.com, FDA Establishment Identifier (FEI) 3043997131, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide, tirzepatide, and liraglutide products.

  1. 1

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

  2. 2

    2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website: “Same active ingredient in Mounjaro® and Zepbound™…” “Same active ingredient in Wegovy® and Ozempic®…” “Our platform provides seamless access to advanced GLP-1 medications, such as compounded Semaglutide (found in Ozempic® and Wegovy®) and Tirzepatide (found in Mounjaro® and Zepbound™)…”

  3. 3

    3. Your website claims “Compounded Semaglutide refers to a medication meticulously formulated [sic] FDA-licensed compounding facility….” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.

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 Momentum Health still operating?

momentumhealth360.com returned a live site on 2026-08-09 with a working shop: the catalogue lists compounded semaglutide, tirzepatide and liraglutide among other products, and the compounded semaglutide product page rendered an add-to-cart control, indicating an operating storefront rather than a closed one.

What this means for what you pay

This letter is worth reading because it puts all three of this market's misleading patterns on one page, and they work at different distances from the product. The label finding is about who made it. The equivalence claims are about what it is. The "FDA-licensed compounding facility" line is about who is vouching for it — and that last one is the reassurance most likely to make you accept a price without asking further, because it sounds like a regulator has been through the door. FDA's answer is unusually flat: there is no FDA-approved or FDA-licensed designation for compounding pharmacies or outsourcing facilities, so the phrase describes an authorisation that does not exist. None of this says the medicine is unsafe. It says the three things a page offered you as grounds for confidence — the maker, the equivalence and the credential — are each softer than they were written to sound.

Has Momentum 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 Momentum 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.