What happened
Original notice title
Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS MARCS-CMS 719339, December 12, 2025
From the archived source record
As described below, these products are unapproved new drugs and were introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “GE Labs Ykarine” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and was introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analysis that a sample of your “GE Labs Ykarine” product contains undeclared trendione (estra-4,9,11-triene-3,17-dione), which is an anabolic steroid and is classified as a schedule III-controlled substance by the U.S. Drug Enforcement Administration (DEA). 1 As described below, FDA has safety concerns about anabolic steroids such as trendione (estra-4,9,11-triene-3,17-dione). As described in FDA's August 2022 Policy Regarding N-acetyl-L-cysteine: Guidance for Industry , 2 we intend to exercise enforcement discretion with respect to the sale and distribution of NAC-containing products that are labeled as dietary supplements and would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the FD&C Act. However, as the guidance notes, the enforcement discretion policy does not apply to NAC-containing products that are adulterated or misbranded under the FD&C Act (other than those misbranded only because they contain NAC and are labeled as dietary supplements). As discussed in further detail below, your “GE Labs Ykarine” product is misbranded under section 502(a) of the FD&C Act because the label does not declare that the product contains trendione (estra-4,9,11-triene-3,17-dione), a controlled substance.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 8eea7e7dfe03
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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