Who is responsible for the safety of dietarysupplements?
FDA is not authorized to review dietary supplement products for safety andeffectiveness before they are marketed.
The manufacturers and distributors of dietary supplements are responsible formaking sure their products are safe BEFORE they go to market.
If the dietary supplement contains a NEW ingredient, manufacturers must notifyFDA about that ingredient prior to marketing. However, the notification willonly be reviewed by FDA (not approved) and only for safety, not effectiveness.
Manufacturers are required to produce dietary supplements in a quality mannerand ensure that they do not contain contaminants or impurities, and areaccurately labeled according to current Good Manufacturing Practice (cGMP) andlabeling regulations.
If a serious problem associated with a dietary supplement occurs, manufacturersmust report it to FDA as an adverse event. FDA can take dietary supplements offthe market if they are found to be unsafe or if the claims on the products arefalse and misleading.
FDA is not authorized to review dietary supplement products for safety andeffectiveness before they are marketed.
The manufacturers and distributors of dietary supplements are responsible formaking sure their products are safe BEFORE they go to market.
If the dietary supplement contains a NEW ingredient, manufacturers must notifyFDA about that ingredient prior to marketing. However, the notification willonly be reviewed by FDA (not approved) and only for safety, not effectiveness.
Manufacturers are required to produce dietary supplements in a quality mannerand ensure that they do not contain contaminants or impurities, and areaccurately labeled according to current Good Manufacturing Practice (cGMP) andlabeling regulations.
If a serious problem associated with a dietary supplement occurs, manufacturersmust report it to FDA as an adverse event. FDA can take dietary supplements offthe market if they are found to be unsafe or if the claims on the products arefalse and misleading.
