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RWD Curtain Lifted On US Cannabinoids Information Gap, But Lawful Use Remains TBD

 
• By Malcolm Spicer

FDA gives directions on research needed for sufficiently robust “real world data” about non-drug products containing cannabinoids. While optimistic that real world data will help bridge information gap about the ingredients' safety, it’s also candid about the size of the gap.

• Source: US Food and Drug Administration

The US Food and Drug Administration is making clear, if it wasn’t already, that the likelihood isn’t improving for lawful use of cannabinoids in non-drug products because the agency has received scant data and other information on the ingredients’ safety.

The agency on 8 January offered extensive directions on conducting studies and other research needed to generate sufficiently robust “real world data” about consumers’ use of dietary supplements, food and other

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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

German Industry Urges ECHA To Reconsider ‘De Facto’ EU Ethanol Ban

 
• By David Ridley

Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By David Ridley

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

AESGP Slams ‘Deeply Concerning And Discriminatory’ EU Wastewater Directive

 
• By David Ridley

“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.