The US FDA has proposed useful tools to register an innovative dietary supplement for manufacturers in a New Dietary Ingredient – Master file (NDI-MF). New and innovative supplemental products have been discovered and submitted as a New Dietary Ingredient (NDI) and submitted to the FDA under the enactment of DSHEA (Dietary and Supplement Health and education Act). Under this law, NDI is to be submitted to the FDA at least 75 days prior the NDI becomes accessible to consumers.

What is an NDI?

An NDI is defined as a dietary ingredient that was not marketed in the U.S. before October 15, 1994 (21 U.S.C. 350b(d)). Thus, to be an NDI, a substance must be a dietary ingredient.

New Dietary Ingredient- Master File


Companies can submit a Master File to the FDA containing drug ingredient and manufacturing procedures for NDI. Submitting a Master file in the NDI notification process can protect the Intellectual Property of the NDI manufacturer and promote consumer access to the safe dietary supplements.

Benefits of Submitting a NDI-MF:

  • Can be referenced by ingredient manufacturers
  • The FDA will protect the Intellectual Property Rights on manufacturing, processing and safety

submission Requirements by Manufacturing company:

  • Submit a confidential NDI-MF including all the information into the NDI notification
  • Give authorization to other companies to reference the Master File by issuing a Letter of Authorization (LOA)
  • In case of adverse events, submit the reports within 14 days of the event
  • Should comply with 21 CFR 111 – cGMP

Regulatory corner:

Any update in the Master file can be done by submitting amendments to the NDI-MF and updating the authorized parties of all the changes made. In case of closing a NDI-MF, the authorized parties and the FDA should be informed.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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