ASN-LABS: 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://asn-labs.com in August 2025 and has observed that your website offers various compounded drug products, including retatrutide and semaglutide. As described below, your retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)]. In addition, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the 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)].

1. 1

   “Your compounded retatrutide drug products fail to meet the conditions of sections 503A and 503B. Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503A, because retatrutide is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list.”

2. 2

   “There are no FDA-approved applications on file for your compounded retatrutide drug product. Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a) and 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.”

3. 3

   “The following claims concerning compounded semaglutide products appear on your website:”

4. 4

   “The same active ingredient as Wegovy and Ozempic”

5. 5

   “Semaglutide is the generic drug in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.”

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)].”

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.

asn-labs.com did not resolve on 2026-08-09: the .com registry servers return NXDOMAIN for it, so a fetch never reaches a server. Registry WHOIS shows the domain still registered — created January 2021, running to January 2028, with nameservers still listed — but carrying the status clientHold, which withdraws a domain from the DNS zone while leaving the registration intact. A domain can be put on hold for more than one reason, and a registration paid up for years is not the profile of an abandoned one, so this is recorded as unknown. It is not evidence the business closed.

The word doing the work in this letter is “generic”. A generic drug is an approved copy: it goes through an FDA application, and FDA rates whether it can be substituted for the brand. A compounded drug is neither of those things, so a sentence calling semaglutide “the generic drug in Ozempic” borrows the standing of the first for a product that does not have it. That matters at the point where a shopper compares a compounded price against a brand price and concludes the cheaper one is the same purchase — the word is what makes the comparison feel like-for-like when it is not. The retatrutide half of the letter is a different finding again, and no edit to the marketing copy would answer it: FDA's position is that no approved application exists and the section 503A and 503B compounding exemptions do not reach those products. Neither half says anything about how the product was made or what was in it; FDA makes no such finding here.

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 ASN-LABS failed to respond.