What happened
Original notice title
Thor Inc. 5/1/17
From the archived source record
The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Unapproved New Drugs and Misbranded Drugs Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Thor’s Fiber Drink “Thor's Dietary Fiber may help reduce blood cholesterol.” “Insoluble fibers have also been shown to reduce incidence of cancer, especially colon cancer.” “The dietary fibers in this product may help regulate blood glucose response. This may help avoid the highs and lows of blood glucose peaks.” Thor’s Cranberry Concentrate “Scientists think that cranberry juice may help prevent the adherence of bacteria to the walls and linings of the bladder and urinary tract.” Thor’s Antioxidant Plus “[H]elp reduce inflammation.” Thor’s Mangosteen Drink “It may also reduce allergies and joint inflammation.” Thor’s Chlorella “It may help restore normal bowel function from things like constipation. Additionally, 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, Thor’s Fiber Drink product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 07657c421602
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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