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

Take Note NDI Notification Filers, US FDA Takes Meetings ‘Before, During Or After’

 
• By Malcolm Spicer

Pre-filing meetings enhance NDIN process efficiency. “When that notification arrives, it's not a blank slate that you're seeing. The pre-NDI meeting may have been weeks or months ago, but it's information there in the back of your mind,” says acting ODSP deputy director Greg Noonan.

Some meetings with new dietary ingredient notification filers before they file are informative for the Food and Drug Administration, while others are necessary lessons for the filers as well as the agency.

“I really like these meetings. I think they're useful when you have someone who's experienced, but they're extremely useful when...

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

US FDA Has Lists To Assure Progress On Supplement Sector Regulations, NDIN Guidance

 
• By Malcolm Spicer

The agency says items on its Human Foods Program’s proposed agenda for guidance “to complete during 2025” include identity and safety information for NDI notifications. Its announcement also links to document about a separate key industry question, a rulemaking which would recognize NAC as a lawful

Portfolios In Large US Food Industry Merger Cleared By FTC Include Nutritional Supplements

 
• By Malcolm Spicer

FTC decision, says Bureau of Competition director Daniel Guarnera, influenced by both companies marketing different lines in different countries, limiting the number of similar products in the same categories the combined firm would offer.

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.

More from Policy & Regulation

US Adverse Event Report Forms Replace ‘Gender’ Options With Male Or Female ‘Sex’ Question

Modifications to forms FDA 3500, for voluntary reporting by healthcare professionals, and 3500A, for mandatory reporting by manufacturers, marketers or facilities, include limiting changing gender question to sex and asking for only male or female answer.

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.