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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

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.

Givaudan Has UTI Health Claim Turned Down In EU

 
• By Tom Gallen

European Food Safety Authority finds no cause and effect relationship between Givaudan's Pacran supplement and defense against urinary tract infections.

US Consumer Health Industry Buckles Up For Another Ride As Trump Swings Tariff Tool Again

 
• By Malcolm Spicer

Manufacturers, marketers and other businesses in the industry may be thinking, “Well, this is different” because the president ordered tariffs on a list of countries rather than on his sole first-term target of China.

Some New Tools, More Old For Supplement Sector Enforcement During Trump’s Second Term

 
• By Malcolm Spicer

Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.

More from Policy & Regulation

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 
• By Malcolm Spicer

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

US Plans End To Petroleum-Based Dyes In Food

 
• By Malcolm Spicer

HHS Secretary Robet F. Kennedy Jr. and FDA Commissioner Marty Makary to announce planned changes as “a major step forward” as part of Kennedy’s “Make America Healthy Again” campaign President Trump has adopted for his administration.

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 
• By Malcolm Spicer

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.