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

NDI Guidance Could Drive Amarin's Gambit To Block Some Omega-3 Imports

 
• By Malcolm Spicer

Amarin's argument would swing on a finding by FDA that synthetics of omega-3s are not dietary ingredients. With such an FDA determination, a fair trade complaint to International Trade Commission about imports of omega-3 ingredients similar to the active ingredient in Amarin's Rx Vascepa theoretically would not be asking ITC to interpret FDA regulations by investigating imports of substances which FDA has not identified as noncompliant with its regulations.

Amarin Corp. PLC says its options following the failure of fair trade complaint against imports of some omega-3 imports include trying again by arguing that synthetic omega-3s are not dietary ingredients.

That argument, says Amarin General Counsel Joseph Kennedy, would swing on a finding by the US Food and Drug Administration...

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 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.

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

 
• By Malcolm Spicer

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.”

More from Policy & Regulation

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.

Clarity Requested For Kennedy’s MAHA ‘Chaos’

 
• By Malcolm Spicer

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.