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Biden Administration Pause On Pending Trump-Era Rules Stalls FDA Cannabinoids Guidance Progress

 
• By Malcolm Spicer

Among four FDA regulatory items withdrawn from OMB review is “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” which the agency submitted in July 2020.

The already long and winding road to FDA allowing lawful use of cannabinoids in non-drug products has become longer and more winding.

Waiting for the US Food and Drug Administration to publish a draft guidance on cannabidiol enforcement? The wait grows longer with the withdrawal of the document along with other pending FDA regulatory items from the White House review process.

President Biden’s chief of staff on 20 January advised the Office of Management and Budget to withdraw from the executive...

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More from Cannabis/CBD

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.

Senate Hemp Regulation Bill’s Broad Prohibition On Synthetics In Supplements Has Industry Attention

 
• By Malcolm Spicer

Provision in Wyden and Merkley’s “Cannabinoid Safety and Regulation Act” referencing FDA authority outside hemp-derived ingredients could provide agency with needed authority to force from the market products labeled as supplements but containing drugs or eliminate the use of many safe ingredients in supplements.

Senate Hemp Regulation Bill Offers Option To House’s Blanket Limit On Levels Of All THCs

 
• By Malcolm Spicer

Democrats Wyden and Merkley author Cannabinoid Safety and Regulation Act to limit sales to consumers 21 and older and authorize FDA to order recalls and impose bans on cannabis products with dangerous chemicals or additives. It also would establish regulatory structure for using cannabinoids found naturally in hemp and allowing “semi-synthetic” ingredients while prohibiting artificial or fully synthetic cannabinoids.

Tobacco Giant Philip Morris Sells Medical Device Business, Keeps Consumer Health Footprint

 
• By Dean Rudge

Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.

More from Ingredients & Safety

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.

‘We Must Have The Truth’ – Calls For UWWTD Review Intensify As Evidence Looks ‘Shaky’

 
• By David Ridley

The evidence underpinning the “polluter pays” principle of the revised Urban Wastewater Treatment Directive - which calls on Europe's pharmaceutical industry to cough up at least 80% of the cost of updating wastewater treatment facilities - is looking increasingly shaky, according to a new report.