What happened
Original notice title
Sanapac Co., Inc. 3/24/17
From the archived source record
Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, 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 the CGMP regulations for dietary supplements found under 21 CFR Part 111. The claims on your website and in your product pamphlet that accompanies your shipments, establish that Unapproved New Drugs The FDA reviewed your website at the internet address www.sanapac.com, and your product pamphlet, which accompanies each shipment to customers. Current medical research shows that foods rich in Beta Carotene may help reduce the risk of lung cancer, certain oral cancers and is known to have beneficial effects on vision.” “VITAMIN B-3- (NIACIN)…lowering cholesterol levels…It is also involved in controlling blood sugar levels…” “VITAMIN B-12…helping to prevent anemia…” “VITAMIN C… helps heal wounds, scar tissue and fractures, builds resistance to infections, aids in the prevention and treatment of the common cold... It may decrease the risk of some cancers.” Inner Man and Inner Man Gold “SARSAPARILLA…is an important aid for cystitis and renal colic from kidney stones. It has also been employed to relieve persistent coughs….” Inner Man Gold, Inner Man, and Inner Women “POTASSIUM…stimulates the kidneys to eliminate poisonous body wastes and assists in reducing high blood pressure.” Your products are not generally recognized as safe and effective for the referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].
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
- 2b9ed3dc80c7
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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