Statement from CHPA SVP of Dietary Supplements Duffy MacKay:
“While we’re pleased to see positive strides being made on this issue under Dr. Welch’s leadership, specifically when it comes to addressing procedures and timeframes, CHPA remains concerned that the final guidance issued today unequivocally asserts that extensive scientific information will be required for every individual dietary supplement product on the market containing an NDI, even if the NDI has already met safety requirements established by the FDCA.
“In CHPA’s comments to FDA on its draft guidance, we urged the agency to confirm an ingredient-focused approach to the NDI notification requirement, rather than the finished product-focused approach suggested in the 2016 NDI draft guidance. Section III.E. of FDA’s Final Guidance highlights the agency’s persistent emphasis on the disparity between the limited number of NDINs filed versus the abundance of products on the market. FDA is essentially doubling down on this point in preemptively establishing a framework, originally proposed in a 2022 draft guidance, that grants an enforcement discretion amnesty window for companies marketing finished supplement products containing an NDI that was not filed with FDA.”
