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Kratom: All Questions On Pre-DSHEA Ingredient Evidence In One Package

 
• By Malcolm Spicer

"Kratom illustrates the promise and the peril of dietary supplement regulation," says Jack Henningfield, Pinney Associates consultant and an expert on abuse liability of various substances. Kratom firms agree NDI notifications are needed for ingredients made from separate kratom alkaloids, but say the botanical itself has decades of safe use in the US.

The numerous questions that complicate proving to FDA that a dietary ingredient was marketed in the US before October 1994 are asked not only about ingredients that are not available, but also about some commonly used today, such as the botanical kratom.

At a recent public meeting on evidence to identify "old dietary ingredients," those available before the grandfather date – Oct....

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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.