Prüvit technologies are categorized as dietary supplements and therefore are not regulated by the FDA, but rather by the Dietary Supplement Health and Education Act. The production facility is an FDA registered "food manufacturer" and complies with Current Good Manufacturing Practices.
For more information, please visit the FDA website:
Who is responsible for the safety of dietary supplements?
The FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
If a dietary supplement contains a NEW ingredient, manufacturers must notify FDA about said ingredient prior to marketing. However, the notification will only be reviewed (not approved) by the FDA, and only for safety (not effectiveness).
Manufacturers are required to produce dietary supplements in a quality manner, and ensure they do not contain contaminants or impurities, and are accurately labeled according to Current Good Manufacturing Practice (CGMP) and labeling regulations.