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Doseworth

FDA warning letter · #716460

Body Good Studio: What the FDA Letter Means for What You Pay

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/body-good-studio-716460-09092025

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

  1. 1

    The following claim concerning compounded semaglutide products appears on your website:

  2. 2

    • “Compound semaglutide is made of the same active ingredients as Ozempic and Wegovy, which are GLP-1 receptor agonist [sic]….”

  3. 3

    Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].

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 Body Good Studio still operating?

bodygoodstudio.com resolved on 2026-08-09 and redirected to joinbodygood.com, a live storefront titled "Body Good — Coverage-first weight care" — the same operator under a shortened name, now leading with "Medicare GLP-1 Bridge · Part D insurance · $39/mo", "Coverage-first pricing, with or without insurance" and "Real clinicians, FDA-approved options". That is a check of whether the site is up and where it points; it is not a check of anything the letter alleges.

What this means for what you pay

Two things are worth carrying away from this one. The first is how literally FDA reads a page. The agency did not paraphrase the sentence or clean it up — it quoted the grammatical slip and marked it "[sic]", which tells you that what gets cited is the exact string a shopper would have read, not a tidied summary of the seller's intent. If a sentence is on the page, it is the sentence. The second is where this business went. The letter concerned a compounded product sold on a comparison to Ozempic and Wegovy; the storefront today leads with insurance coverage, a Medicare Part D bridge and the phrase "FDA-approved options", at $39 a month. That is a different business model with a different honest answer to "is this the approved drug" — and it is the one place in this collection where you can watch a seller move from arguing that its product is like the approved one to arranging for people to get the approved one. Neither the letter nor this page says the earlier product was unsafe: FDA made no finding about quality, contents or manufacturing, and has not closed the letter out. What it found was a sentence.

Has Body Good Studio 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 Body Good Studio failed to respond.

Sources

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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.