The Natural Products Association (NPA) is the leading representative of the dietary supplement industry with over 1,900 members, including suppliers and retailers of vitamins and other dietary supplements. NPA Executive Director and CEO John Shaw and Vice President of Scientific and Regulatory Affairs Dr. Cara Welch respond to the decision by the Food and Drug Administration (FDA) to rewrite the New Dietary Ingredients (NDI) draft guidance:
John Shaw: “NPA is pleased that the FDA will rewrite the NDI draft guidance to provide greater clarity and address concerns that the document is not in line with the intent of DSHEA. This action by the FDA shows that they are committed to an open dialogue with industry on these issues.
“We appreciate their desire to get it right and we all need to work together to find a solution acceptable to both sides—the industry and the FDA. I’d like express my heartfelt gratitude to our members for their input and support, and to our Congressional champions for their tireless efforts on behalf of the industry.”
Cara Welch: “NPA looks forward to working with the agency on the five areas of most concern to the industry. These include how to establish grandfathered ingredient status, define what 'chemically altered' means, and determine when synthetic botanical constituents are permissible, when a filing is needed for ingredients or products, and what level of safety data is required for a submission.
“While the draft guidance is being rewritten, industry must still submit notifications for new dietary ingredients. NPA will continue to educate the industry about their requirements under the law while we work with the FDA on a new draft that will ultimately be most beneficial for consumers.”
For more information, visit NewHope360's NDI Guidance Center.