August 27, 2020
FDA Proposes Integrating Master Files to NDI Notification

Industries across the world are evolving in terms of innovation, and it is no different for the food supplements industry. The food and food supplements industry is booming and majority of its credit goes to the innovative products that are being introduced in the global markets. In most of the cases, new products are manufactured with the help of novel ingredients known as ‘New Dietary Ingredients’ (NDI).

What is a New Dietary Ingredient (NDI)?

An NDI is a food supplement ingredient that was not marketed in the United States (US) before October 15, 1994, according to the Dietary Supplement Health and Education Act (DSHEA). It is the responsibility of a manufacturer/distributor to determine and document whether a dietary ingredient is NDI or not. As per the DSHEA, manufacturers are required to ensure the safety and efficacy of the NDI and must submit a detailed notification for the ingredient review to the US Food and Drug Administration (FDA). However, before distributing a product with an NDI in the US market, manufacturers must ensure that the ingredient is considered as a dietary ingredient as per the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The review application for an NDI must be submitted 75-days before the product reaches the US market.

NDI Notification – Master File Component

Although the FDA asks food supplement manufacturers to notify NDI to the agency, many fail to do so for various reasons, certainly because of limited clarity on the definition of NDI. This may act as an issue for the FDA to ensure the safety of innovative products placed on the market. To overcome these issues and ensure manufacturers that the intellectual property rights related to the NDI are protected through the notification process, the FDA has proposed to add a master file component to the pre-market process of food supplements, i.e., NDI notification. The purpose of the NDI master file (NDI-MF) is to help manufacturers protect valuable information about their NDIs, like, information related to manufacturing, safety and processing.

How will the NDI-MF work?

If a manufacturer submits an NDI-MF to the FDA for one of their food supplements, it can be referenced by another manufacturer for an NDI notification with the due permission of the NDI holder. The implementation of NDI-MFs can also streamline the notification process and reduce the paperwork burden for manufacturers as well as the agencies, as it will help multiple notification submitters to reference a single NDI-MF. In short, submitting an MDI-MF will have the following benefits:

  • It can be used by other ingredient manufacturers as a reference
  • The FDA will protect the intellectual property rights of the IND holders

To submit an NDI-MF, manufacturers must fulfil the following steps:

  • Manufacturers must submit all the NDI-MFs along with all the necessary information through NDI notification
  • Manufacturers must provide authorization to other companies, allowing them to reference the NDI by issuing a Letter of Authorization (LoA)
  • If any adverse event arises, the FDA must be informed immediately
  • Manufacturers must comply with the 21 CRF 111 – cGMP

As the FDA prioritizes the safety of food products, this step of proposing an NDI-MF creates a harmonized Regulatory framework to focus on the safety of each ingredient. While the FDA is still in discussion about the proposal, it is crucial for food supplement manufacturers to keep an eye on the evolving regulations of the U.S. to ensure compliance. To do so, manufacturers are advised to consult a Regulatory expert in US food supplements for successful market-entry. Stay safe. Stay compliant.