Described as “much-needed reform around claims language, drug preclusion, and federal supremacy clause reform to forestall state-by-state regulation over supplements,” take a look at “DSHEA 10.0.”

Tune in for an insightful discussion on supply chain challenges, the impact of tariffs, the MAHA movement and more issues impacting the natural products industry.

Get updated on the biggest issues impacting the natural products industry, including tariffs, state actions impacting the dietary supplements space, HSA/FSA expansion, GRAS, MAHA, and more

"These materials are intended to help simplify the process for manufacturers and distributors, resulting in more complete NDINs submitted to the FDA and facilitating the agency’s scientific review," FDA said. 

This lawsuit follows earlier efforts by NPA on NMN, which became necessary after a November 2022 notification by FDA declared that NMN is not a legal dietary ingredient

While we welcome FDA’s attention to the important and outstanding issues associated with the NDIN requirement, the Guidance is incomplete and does not do enough in describing the master file system," said CHPA's Duffy MacKay.

FDA said the guidance responds to the supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs).

FDA's guidance is to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs).

The Council for Responsible Nutrition (CRN) submitted a letter to the FDA in response to FDA's inclusion of "Dietary Supplement Master Files: Draft Guidance for Industry" in its list of priority guidance documents for 2023 as one part of the agency's New Dietary Ingredient (NDI) Notfication final guidance to be released in several parts in the future.