CHC regulation: News from EFSA and FDA

The European Food Safety Authority has stated that its scientists “cannot currently establish the safety of cannabidiol as a novel food owing to data gaps and uncertainties about potential hazards related to CBD intake”. Following the submission of numerous applications under novel food regulations, the European Commission asked ESFA to give its opinion on whether CBD consumption was safe for humans. EFSA’s expert Panel on Nutrition, Novel Foods & Food Allergens (NDA) believes there is insufficient data on the effect of CBD on the liver, GI tract, endocrine and nervous systems and psychological wellbeing. While studies in animals show significant adverse effects especially in relation to reproduction, it is important to determine if these effects are also seen in humans.

In other notable CHC regulatory news, the FDA has placed Sanofi’s Actual Use Trial to support the Rx-to-OTC switch of ED treatment Cialis (tadalafil) on hold, owing to concerns about the protocol design. Cialis is the only PDE-5 inhibitor that offers men a choice when it comes to treatment for ED – for use as needed and for once daily use. The AUT has not yet recruited any patients, but Sanofi noted that it “continues to work with the FDA to move the programme forward and will engage the agency in upcoming meetings as it determines the next steps”.

Source: EFSA

Nicholas Hall’s Touchpoints: Why am I not surprised at the latest EFSA ruling on CBD? Even though the Chair of the NDA Panel, Professor Dominique Turck, has let a crumb of comfort drop from his high table when he said, “It is important to stress at this point that we have not concluded that CBD is unsafe as food”, the announcement will have disappointed an industry and the many manufacturers who have sunk millions into proving the unique benefits of this new class of consumer healthcare products. This is, after all, the organisation that won’t allow probiotics to be named as probiotics on packaging, although it seems to me highly significant that the authorities in Spain and Netherlands are leading the way to override this ridiculous ruling by the Dr.No’s at EFSA. 

In much the same way, California is pioneering the move for hemp-derived CBD to be treated as supplements and eventually brought under the DSHEA umbrella. This is another crumb of much-needed comfort at a time when the FDA seems in a state of paralysis regarding the regulation of medicinal cannabis. And I’m extremely concerned with the recent news that the FDA has stopped Sanofi’s Actual Use Trial for the switch of Cialis, which my good friend Mary Alice Lawless believes could be a threat to the whole switch process in USA.

Explore the best CBD and lifestyle launches from 2021 in the Innovation Showcase featured in our recent Innovation in CHC report. Drawn from CHC New Products Tracker, you can also explore innovation by marketer, region and country. To order your copy, or for further information, please contact melissa.lee@NicholasHall.com.

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