What happened
Original notice title
Supplement Science Corp. d/b/a Condemned Labz MARCS-CMS 613165, September 22, 2021
From the archived source record
Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Unapproved New Drugs and Misbranded Drugs FDA reviewed your website at [see original source] in June, July and September 2021 and has determined that you take orders there for the products Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements Your products Arsyn and ConvictStim are labeled as dietary supplements. Even if your products Arsyn and ConvictStim did not have therapeutic claims that make these products unapproved new drugs and misbranded drugs, they would be adulterated dietary supplements. Under section 413(a) of the Act [21 U.S.C. 350b(a)], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. 342(f)] unless it meets one of two requirements: 1. Products for which the manufacturer or distributor is required to submit a new dietary ingredient notification under section 413(a)(2) and 21 CFR 190.6, but for which the required notification has not been submitted, are adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. 342(f) and 350b(a)]. Therefore, even if a new dietary ingredient notification had been submitted, dietary supplements containing higenamine would be adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. 342(f) and 350b(a)].
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
- 094f79922151
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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