What happened
Original notice title
The Herbalist, Inc. 5/25/17
From the archived source record
During the inspection, our investigators evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations and identified significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Part 111. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. 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, Ache-Less, Ache-Less Rub, Antispasmodic Tonic, Blood Pressure Be Well, Circutone, Cough-Eze Syrup, Ener-CHAI-Zing Tea, Healing Heart, Lung Defend, Respiratory Rescue Triple Kit, and Respitonic fail to bear adequate directions for their intended uses 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 During our inspection, our investigators observed the following significant violations of the dietary supplement CGMP regulations, which were noted on the Form FDA 483, Inspectional Observations, issued to you on November 4, 2016. Your Echinacea Root, Ache-Less, Immuno- Blast, Kids Be Calm, Dream Sleep, and Sinutone products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the labels fail to bear nutrition labeling in the form of a (“Supplement Facts”) label, as required by 21 CFR 101.36. 2.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 9a8e8a049500
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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