What happened
Original notice title
Herbal Vitality, Inc. MARCS-CMS 640206, March 07, 2023
From the archived source record
The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. Unapproved New Drugs and Misbranded Drugs During the inspection, our investigator collected finished product labels for your products and the Herbal Vitality product catalog in which you offer your products for sale. 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, your products fail to bear adequate directions for its intended use and, therefore, your 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Dietary Supplement CGMP Violations During the inspection, our investigator found significant violations of FDA’s regulation 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). Based on the inspection, we determined that these violations cause the dietary supplements 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Additionally, even if your Children’s Tonsillitis/Otitis product were not an unapproved new drug, it would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Your significant violations of the CGMP requirements are as follows: 1.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 92187630a447
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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