CRN’s Comments on NDI Draft Guidance Note Progress, Address Lingering Industry Concerns

Washington, D.C., December 13, 2016—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, formally submitted comments to FDA in response to the agency’s revised New Dietary Ingredient (NDI) Draft Guidance released earlier this year. In its comments, CRN commended FDA for providing a clearer articulation of how the agency interprets requirements of the law and what it expects should be included in an NDI notification. However, CRN also took the opportunity in its comments to strongly reemphasize disagreement with some of the document’s specifics that will prove unnecessarily burdensome to the industry without increasing safety benefits for consumers.

According to Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, CRN, “We have been waiting more than five years for this document and, after close review, consider it a step in the right direction. We’re appreciative that the revised draft guidance appropriately addresses several issues raised by industry in response to the 2011 draft guidance and provided a better explanation of the agency’s thinking, but there are still items we take issue with.”

On a positive note, CRN welcomes FDA’s plan to allow firms to submit confidential NDI master files that will provide for the protection of intellectual property. In addition, CRN supports FDA’s willingness to create an authoritative safe harbor list of dietary ingredients established to be on the market prior to the passage of the Dietary Supplement Health and Education Act (DSHEA) and therefore not subject to NDI notification requirements. CRN advises such a list would protect newer manufacturers not in possession of physical evidence that an ingredient was on the market over twenty years ago. 

However, CRN takes issue with the agency’s approach to evaluating evidence of pre-DSHEA marketing in order to create that authoritative list, as well as its interpretation of other exceptions to NDI notification requirements. CRN remains concerned that a narrow interpretation of these exclusions will result in unnecessary NDI notifications for products with a long history of safe use. Also at issue is FDA’s interpretation of sections of the Federal Food, Drug, and Cosmetic Act (FDCA) and DSHEA relating to the definition of “dietary ingredient.” Said Dr. MacKay, “In particular, the agency’s interpretation on this does not honor the spirit of DSHEA.”

Dr. MacKay added, “Moving forward, we request that FDA offers the industry a more collaborative opportunity to develop reasonable changes to future guidance for NDI notifications. Giving industry the opportunity to weigh-in on decision making—particularly when it comes to an authoritative list of pre-DSHEA dietary ingredients and the implementation of the NDI Master file—is an appropriate and productive way to ensure all parties are heard from and satisfied. Industry should be seen as a resource.”

Note to editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit Follow us on Twitter @crn_supplements and @wannabewell and on Facebook.