Ask Our Experts: EIHA’s New Approach per Novel Food

 

Q: How do you think that the EIHA’s new approach to novel food restrictions will pan out for the whole plant food supplements market?

By New Frontier Data

A: As in the United States, there is an ongoing debate in the European Union (EU) about how to regulate cannabidiol (CBD). Though there is significant consumer interest and demand, EU regulators have been hesitant to allow unrestricted sales of either CBD extracts or full-spectrum hemp oil.

Instead, the European Medicines Agency (EMA) has chosen to classify CBD as a “novel food.” According to EU law, a novel food is one that had not been consumed to a significant degree by humans in the EU prior to May 15, 1997. Products deemed as novel foods must undergo stringent testing and safety evaluations before being sold among EU member nations.

The European Industrial Hemp Association (EIHA) has long argued that CBD should not be declared a novel food, given that Europeans have consumed hemp (not considered a novel food) for thousands of years. Ipso facto, people have by proxy also consumed CBD for thousands of years, if unwittingly. The EMA has remained unconvinced by the argument.

Trying another tack, the EIHA now contends that while CBD-enriched extracts are novel, food products containing hemp parts are not. Under that definition, full-spectrum hemp extracts —which contain lower concentrations of CBD than do pure extracts — would be allowed for sale on the EU market without undergoing required testing and safety evaluations.

Though the distinction might help to strengthen the EIHA’s overall argument, it seems likely not to persuade regulators. It is possible that a change in EMA policy might be precipitated by action from the U.S. Food and Drug Administration to regulate CBD, but that outcome, too, seems uncertain and on hold until after the COVID-19 pandemic is under control.