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

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

More from Regulation

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

 
• By 

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 

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.

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

 

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”

Proponent For Age-Restricting Diet Supplement Sales Adds ‘Health Inequities’ To Argument

 

Result of firms marketing weight loss products to Black and Latino girls and to lower-income households is to “worsen health inequities by gender, race, ethnicity and income,” says Harvard researcher Bryn Austin, director of Strategic Training Initiative for the Prevention of Eating Disorders.

More from Policy & Regulation

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

 

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.

Clarity Requested For Kennedy’s MAHA ‘Chaos’

 

Discussion of the administration’s “Make America Healthy Again” campaign at a recent regulatory conference provided a platform for questions about what HHS Secretary Kennedy wants and how he expects to get there.

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

 

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”