pre-market approval

Box of fish oil dietary supplement and bottle of fish oil dietary supplement encased in ice

22 Sep: FDA Proposes Mandatory Pre-Market GRAS Reporting

Under a proposed new rule from the Food and Drug Administration (FDA), the voluntary self-affirmed Generally Recognized as Safe (GRAS) notification program would be converted into a mandatory pre-market notification requirement for certain dietary supplement and functional food ingredients. The proposal could improve ingredient transparency, but mandatory GRAS review may also delay product launches, discourage innovation, and reduce consumer choice….