1. HBW Insight
  2. >>Wellness
  3. >>Policy & Regulation
  4. >>Regulation

US FDA’s NDIN Master File Draft Guidance Notes ‘No Presumption’ To Keep Information Confidential

 
• By Malcolm Spicer

FDA ODSP explains that whether information will be deemed a trade secret or otherwise confidential commercial information inaccessible to other firms in an NDIN master file is subject to Freedom of Information Act regulations and the relevant Food, Drug and Cosmetic Act rule.

• Source: Shutterstock

The Food and Drug Administration’s draft guidance on master files for new dietary ingredient notifications likely will boost the US dietary supplement industry’s knowledge of federal regulations on protecting trade secrets and other confidential information.

Industry stakeholders, meanwhile, agree with the FDA that allowing NDI notifiers to use master files for allowing certain other businesses...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

EU Industry Wants EFSA Changes To Support Innovation

 
• By Tom Gallen

Prominent trade groups call on the European Commission to improve risk assessment of innovative food products by making changes to processes at the European Food Safety Authority.

US FDA Clarifies Success For An NDI Notification Fits Only The Notifier’s Ingredient

Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.

AESGP Annual Meeting: Harmonizing EU VMS Max Levels Could Cost Sector Over €200m

 
• By David Ridley

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from Policy & Regulation

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

CHPA Survey Shows Consumer Trust In Supplements Strong, Not So Much In Regulation

 
• By Malcolm Spicer

Results of survey found a majority of representative sample of US voters nationwide agree “current regulations should be updated and strengthened to protect consumers,” CHPA says.