What happened
Original notice title
Nature’s Elements, Inc. MARCS-CMS 719302, April 07, 2026
From the archived source record
Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website www.natureselements.net, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs FDA reviewed your website at the Internet address www.natureselements.net in October-December 2025 and has determined that you take orders there for the products He Shou Wu, Advanced He Shou Wu, Schizandra Berry extract, DHT Blocker, and Cordyceps. Misbranded Drug 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, Schizandra Berry extract and DHT Blocker 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 The inspection of your facility on October 14-16, 2025 identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the He Shou Wu, DHT Blocker, Cordyceps, Maitake Mushroom, and D-Aspartic Acid (Monster T) products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
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
- d6142ac44511
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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