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NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA

 
• By Malcolm Spicer

FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.

Vitamins

Improving compliance with the US Food and Drug Administration's premarket notification requirement for dietary ingredients is the focal point of the agency's discussion on strengthening its dietary supplement industry oversight.

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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

Loper Bright Could Trip FDA On Self-Affirmed GRAS

 
• By Malcolm Spicer

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

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.

Momentum Of Questions About Self-GRAS Meets Wall Of Exemption From ‘Rigorous Review’

 
• By Malcolm Spicer

HHS Secretary Kennedy ‘s opposition to allowing GRAS without notifications has support but also questions just as strong about whether FDA is authorized to conduct a rulemaking to eliminate the option.