SemaBio: 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://sema.bio 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 repeatedly appears on your website:”

2. 2

   “• “generic semaglutide””

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)].”

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.

sema.bio resolved on 2026-08-09 but served a 109-byte page whose only content is a redirect to /lander, and that lander is a registrar parking template — it loads no storefront, only the parking script (window._trfd.push({ap:"parking"})). A parked domain is not evidence a business has closed: parking can be reversed, and a company can trade under a different domain. Recorded as unknown rather than ceased-operations.

"Generic" is the most expensive word in this collection, because it is the one shoppers already know how to price. At a pharmacy counter it means something precise and protective: an FDA-approved copy of an approved drug, shown to be therapeutically equivalent, made under the same rules, substitutable at the counter, and cheaper because the patent expired rather than because the standard dropped. Every one of those guarantees is why people relax when they read it. There is no approved generic semaglutide in the United States. So the word arriving beside a compounded product does not describe a cheaper version of the same thing — it imports a set of assurances that were never issued, and it does so in two syllables, without naming a brand or making a comparison anyone could check. That is why FDA's phrasing matters here: the claim "repeatedly appears", which is what makes it the site's vocabulary rather than a slogan someone could have removed with one edit. The domain is parked today and nothing is on sale behind it. The letter says nothing about how the products were made or what was in them, and FDA has not closed it out.

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 SemaBio failed to respond.