What happened
Original notice title
Best Nutrition Products, Inc. MARCS-CMS 556642, September 07, 2018
From the archived source record
The inspection revealed 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 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 CGMP requirements for dietary supplements. The labeling of these products establish that they are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] as detailed below. Unapproved New and Misbranded Drugs Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Bael Golden Apple On the webpage [see original source] “Bael has been shown to help in healing of ulcerated intestinal surfaces. 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 Arjuna, Bael Golden Apple, Boswellia, DHEA, Gotu Kola, GTF Chromium, Guduchi, Hawthorne, Lecithin, Tribulas, and Yohimbe 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)]. Dietary Supplement CGMP Violations The inspection revealed the following significant violations of the 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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 2dbdafcfeceb
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 →