Dietary Supplements Not Fda Approved

If the dietary supplement contains a new ingredient manufacturers must notify fda about that ingredient prior to marketing.

Dietary supplements not fda approved. For most claims made in the labeling of dietary supplements the law does not require the manufacturer or seller to prove to fda s satisfaction that the claim is accurate or truthful before it. The fda oversight of supplements is a bit convoluted. A dietary supplement is considered new if it contains an ingredient not recognized as a food substance unless it was sold as a supplement before october 1994.

Office of dietary supplement programs hfs 810 food and drug administration 5001 campus dr college park md 20740. To contact the office of dietary supplement programs email. Except in the case of a new dietary ingredient where pre market review for safety data and other.

This means that dietary supplements do not need approval from fda before they are marketed. Prior to 1994 supplements were subject to the same regulations as any other food. Supplements are typically not regulated by the fda so there is no supplement police there is no process to test or assure the purity of a different supplement or whether certain supplements are combined with other things.

15 1994 require a notification to fda. However the notification will only be reviewed by fda not approved. Most bottles list on the packaging that the fda has not approved the product prior to its availability on the market.

If it is new the manufacturer must provide the fda with reasonable evidence that the new ingredient is safe before the supplement is marketed to the public.