What happened
Original notice title
Black Seed Herb, Inc. 7/11/17
From the archived source record
Based on our inspection, we identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Further, we have reviewed the labels used on several of your products and have identified significant violations causing the products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). We received your response, dated October 5, 2016, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm on September 21, 2016. We address this response below, in relation to each of the noted violations. Unapproved New Drug and Misbranded Drug Violations As discussed above, FDA reviewed your product labels obtained during the inspection and your website at the Internet address [see original source] in April 2017 and determined that you take orders on your website for the products Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules and Black Seed w/ Olive Leaf/Garlic Capsules. 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, these products 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)]. Although violations associated with your labels and website were discussed during the inspection, your October 5, 2016 response makes no reference to any correction of these violations.
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
- 5643b15006ad
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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