Is Renadyl™ FDA approved?
FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.*Manufacturers must make sure that product label information is truthful and not misleading. The probiotic ingredient strains used in our proprietary, patented formulation are considered safe under Generally Recognized as Safe (GRAS) classification by the FDA.