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Doseworth

FDA warning letter · #715878

ybycmeds: What the FDA Letter Means for What You Pay

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/ybycmeds-715878-09092025

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://ybycmeds.com 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

    • “Semaglutide for weight loss - Prefilled Syringes, similar to Ozempic or Wegovy”

  3. 3

    • “Tirzepatide for weight loss - Prefilled Syringes, similar to Mounjaro and Zepbound”

  4. 4

    • “Tirzepatide Peptide 60mg vial - similar to Mounjaro and Zepbound”

  5. 5

    • “Semaglutide Compound 10mg vial - similar to Ozempic or Wegovy”

  6. 6

    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 [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 ybycmeds still operating?

ybycmeds.com returned a live storefront on 2026-08-09 titled "YBYC - Information source for abortion and weight loss", with Women's Health and Weight Loss shop sections, Organization structured data naming "YBYC Meds", and a site-wide notice reading "Shipping to Alabama is restricted for certain products". That is a check of whether the site is up and what it sells; it is not a check of anything the letter alleges.

What this means for what you pay

This is the useful one for anyone who assumes careful wording is a defence. Four listings, and not one of them claims the product is the same as anything — the strongest word on the page is "similar". FDA cited all four. The reason is that the finding is not about the adjective, it is about what the sentence leaves a reader believing, and "similar to Ozempic" sitting in a product title next to a price does the same work as "generic": it tells you what this is FOR by pointing at something that has been approved for it. The listings are also unusually specific in the wrong direction — "Tirzepatide Peptide 60mg vial", "Semaglutide Compound 10mg vial" — because a milligram figure attached to a vial is not the same kind of number as a dose on an approved pen, and comparing the two is how people end up comparing prices that are not comparable. What this letter does NOT do is say anything about what is in those vials, or how they were made, or whether the site's other categories are affected. It is a finding about four lines of product copy, it has not been closed out, and it is not a recall or a charge.

Has ybycmeds 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 ybycmeds 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.