Trust 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://coretrustlabs.com in August 2025 and has observed that your website offers various compounded drug products, including retatrutide, semaglutide and tirzepatide. 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 and tirzepatide 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)].

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 products. 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 and tirzepatide products appear on your website:”

4. 4

   “FDA approval: Semaglutide was approved by the U.S. Food and Drug Administration (FDA) in December 2017.”

5. 5

   “FDA approval: Tirzepatide was approved by the U.S. Food and Drug Administration (FDA) in 2022.”

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.

Two domains from the letter were checked on 2026-08-09 and they point in opposite directions. coretrustlabs.com — the address FDA says it reviewed — resolves and returns a “Launching Soon” placeholder carrying a contact form and a 2026 copyright line, with no catalogue or checkout reachable. coretrustlab.com, the domain of the contact email in FDA's recipient block, also resolves and redirects to a separate live site trading under the Trust Labs name. A placeholder on the reviewed domain is not evidence of closure when the recipient's other domain is answering, so this is recorded as unknown.

This is the clearest case in the index of true sentences used to leave a false impression. Semaglutide was approved in December 2017; tirzepatide in 2022. Both dates are correct, and both were printed under the heading “FDA approval” on pages selling compounded products, which have no approval of their own. The check a reader can apply is short: an approval attaches to one specific product from one specific application holder, never to an ingredient in the abstract — so an approval date on a compounded product's page is describing a different product from the one going in the cart. It also means scanning for obviously overblown language will not protect you here, because there was none to find. The retatrutide half of the letter is a separate matter and is not about wording at all: FDA's position is that no approved application exists and that the section 503A and 503B exemptions do not reach those products. Neither finding concerns manufacturing quality, and the letter makes no claim about it.

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 Trust Labs failed to respond.