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CDB Supplements Next On FDA's Investigational New Drug Warning List

 
• By Malcolm Spicer

The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made in statements including testimonials on their websites for products varying from oils, capsules, tinctures and lotions to snacks including gummies and lollipops.

FDA for the second consecutive day, and for the second time in 20 months about cannabidiol products, on Nov. 1 announced warnings to dietary supplement firms that investigational new drug studies of an ingredient precludes its use in dietary supplements.

The agency published warnings to four firms marketing supplements containing CDB ingredients with claims to treat or cure cancer made...

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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.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

Review Suggests Advantage Of Bayer’s Iberogast Advance For Digestive Disorders

 
• By David Ridley

Bayer's Iberogast Advance's combination of six herbal ingredients may produce a synergistic effect that acts on multiple underlying issues contributing to digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS), a recently published study suggests.

Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
• By Malcolm Spicer

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

More from HBW Insight

Innovations In US Hemp Market, Like States’ Regulatory Interest, More Than Skin Deep

 
• By Malcolm Spicer

Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.

House Bill Aims to ‘Modernize’ US FDA’s Review Process For Sunscreens

 
• By Eileen Francis

Four co-chairs of the House of Representatives’ Skin Cancer Caucus have introduced the Safe Sunscreen Standards Act to direct FDA to establish clearer, ‘more flexible’ standards for evaluating sunscreen ingredients.

Germany’s PharmaSGP To Be Taken Private

 
• By Tom Gallen

Consumer health player PharmaSGP will be taken private by its biggest shareholder, FUTRUE.