Cosmo Med Spa: What the FDA Letter Means for What You Pay

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://cosmomedspa.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. As described below, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].

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   ““Ozempic (semaglutide) injection (4 weeks supply)””

2. 2

   ““Ozempic (semaglutide) injection (10 weeks supply)””

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, 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)].”

4. 4

   “If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.”

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.

On 2026-08-09 https://cosmomedspa.com returned HTTP 301 to https://www.cosmospamarkham.com/ — the domain FDA reviewed now redirects to a different domain — where a live storefront titled "Products | Cosmo Spa Markham" sells skincare brands, injectables and IV therapy with working prices and cart. The business is operating; the cited Ozempic listings do not appear in the product catalogue as fetched.

The unit of sale is the thing to look at here. "Ozempic (semaglutide) injection (4 weeks supply)" prices a brand-name drug by how long it lasts, which is exactly how a compounded vial is normally sold and exactly how an approved pen is not — a pen is sold by strength and pen count, because the dose you titrate up to changes how long one lasts. So the listing quietly promised a fixed duration for a drug whose duration depends on your dose, under a brand name that was not what would arrive. When a page prices medication in weeks, the question that follows is always "weeks at what dose", and there is no way to answer it from a title alone. The second thing worth knowing is jurisdictional. This recipient is in Ontario, and FDA's letter includes the paragraph it reserves for sellers outside the country: products may be detained at the border, and FDA may notify the regulator where the seller operates. For a buyer, that is not a safety warning — it is a delivery risk, and a quiet reminder that a site can be a foreign business even when its checkout is in dollars and its copy names US brands. The domain FDA reviewed now redirects to a Markham spa storefront that no longer lists the medication at all.

As of August 2026, 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 Cosmo Med Spa failed to respond.