Reports (US FDA, 2024): Dietary Supplements: Industry Guidance for New Dietary Ingredient (NDI)

“The main subject of the regulatory information is the requirements and procedures for submitting New Dietary Ingredient (NDI) notifications for dietary supplements in the United States.
The document describes the release of three guidance documents by the U.S. FDA in March and April 2024. These documents focus on NDI reporting for dietary supplements and provide information on reporting requirements, procedures, and NDI information master files. The guidance is expected to benefit the domestic functional ingredient export industry.It covers the following information:This document describes a general overview of the requirements and considerations for submitting an NDI notification to the FDAClassification of Food Contact Substances and Indirect Food Additives: This section examines whether food contact substances and certain indirect food additives can be classified as dietary ingredientsNew Dietary Ingredient (NDI) Notifications: This section covers the requirements and procedures for submitting NDI notifications, including the information that should be included in the submissionsThe document describes the importance of including details like chromatographic column, solvent elution conditions, and reference standards when identifying an analyte using a specific methodAcceptance criteria should be clear and specific, and the matching of peaks in chromatography or spectra should be sufficiently detailedManufacturers and distributors of dietary supplements must establish specifications for the identity, purity, strength, composition, and limits on contamination of their productsThe notification should list and explain the role of these specifications relevant to the identity of the New Dietary Ingredient (NDI) and to the safe consumption of the dietary supplement containing the NDIIf an NDI is produced using fermentation or is a live microbial dietary ingredient, additional information should be included in the notificationThe notification should also describe the conditions of use recommended on the labeling of the dietary supplementSafety information required to support an NDI notification includes both a history of safe use and safety testing dataThe reliability of history of use data is evaluated, and additional animal and human studies may be recommended to supplement evidence of a history of safe useThe selection of doses for safety studies should be based on biological information and not on providing a predetermined margin of safetyThe top dose in clinical studies should be governed by safety considerations and be as high as feasible within safety limitsUnpublished scientific work should be described in detail, and raw data may be requested by the FDA during the review of the NDINInformation believed to be trade secret or Confidential commercial information (CCI) should be clearly identified in the NDIN, and the basis for this belief should be explainedFor botanical NDIs, the identity section should deal with toxins in related plants or microorganisms, and the description of an extract or concentrate should include an overview of the manufacturing process and a description of all added ingredients”

Source: https://www.mfds.go.kr/brd/m_1060/down.do?brd_id=data0011&seq=15493&data_tp=A&file_seq=1##~https://www.mfds.go.kr/brd/m_1060/view.do?seq=15493&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

Region:  South Korea