FDA Should Consider Public Health Implications of Supplement Ingredients List

The Pew Charitable Trusts submitted comments to the Food and Drug Administration on Dec. 4 regarding the agency’s plan to create a list of dietary supplement ingredients that were on the market before passage of the Dietary Supplement Health and Education Act of 1994. Products containing ingredients that predate the legislation can be marketed without prior notice to FDA.

Pew recognizes that such a list could be useful for supplement manufacturers and the agency, because it would reduce unnecessary submissions to FDA. However, because sourcing and manufacturing changes to ingredients marketed before 1994 can introduce new risks, Pew recommends that FDA take a conservative approach to creating the list. And since dietary supplements have not been evaluated, FDA should ensure that advertising and marketing materials do not misrepresent the list as an indicator of safety. Finally, because the list has limited benefits for public health, Pew cautions against prioritizing FDA resources for it above other critical functions.