What happened
Original notice title
Ironmag Labs MARCS-CMS 622504, May 04, 2022
From the archived source record
Based on our review of your website [see original source] and other relevant evidence, CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate are unapproved new drugs sold in violation of section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. Furthermore, your CBD-containing product is a misbranded drug under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. As explained further below, introducing or delivering these unapproved and misbranded drugs for introduction into interstate commerce violates the FD&C Act. Adulterated Dietary Supplements: New Dietary Ingredients The label of your Ephedra Stack product declares higenamine as a dietary ingredient. Under section 413(a) of the FD&C 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 FD&C 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 FD&C Act [21 U.S.C. §§ 342(f) and 350b(a)]. Therefore, even if a new dietary ingredient notification had been submitted, dietary supplements containing hordenine or higenamine would still be adulterated under sections 402(f) and 413(a) of the FD&C Act [21 U.S.C. §§ 342(f) and 350b(a)]. In the absence of adequate information to provide reasonable assurance that hordenine and higenamine do not present a significant or unreasonable risk of illness or injury, dietary supplements containing hordenine or higenamine are adulterated under section 402(f)(1)(B) of the FD&C Act [21 U.S.C. § 342(f)(1)(B)]. The introduction into interstate commerce of dietary supplements that are adulterated under sections 402(f) and 413(a) of the FD&C Act is prohibited under sections 301(a) and (v) of the FD&C Act [21 U.S.C. § 331(a) and (v)].
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
- 6119c366f548
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.
Sources, dates, and coverage →