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FDA Road To Decision On Expanding CBD Uses Starts With Weighing Impact On Existing And Future Use As Drug

 
• By Malcolm Spicer

At public hearing, FDA officials starting with acting Commissioner Sharpless emphasized CBD is approved only as a drug and deciding on allowing its use in any other type of FDA-regulated product will be done with potential impact on drug development foremost in agency's thinking. Also apparent from questions 12-member panel of FDA officials asked was a potential regulatory pathway for clearing hemp and CBD as dietary ingredients will require resolving concerns about the substances' dose or concentration levels and establishing ingredient identity standards.

CBD Molecule

US Food and Drug Administration officials are making clear that their consideration of cannabidiol's use as a dietary ingredient will prioritize weighing the potential impact of slowing or interrupting the development of drugs using cannabis-derived substances.

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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

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.

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.