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Mile High Labs Submits European Novel Food Application for CBD Products

By Leo Bear-McGuinness

Published: Apr 21, 2020   
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The Colorado-based CBD producer Mile High Labs has become one of the first companies to file a novel food application to the European Food Safety Authority (EFSA) and the UK Food Standards Agency (FSA) for its CBD isolate ingredient and CBD products.

The submission is the first from a member of the Association for the Cannabinoid Industry (ACI), a leading CBD industry body in the UK.

Signed, sealed, delivered

Until recently, the UK’s booming CBD market had largely outpaced official regulation. But in February, the country’s FSA stepped in and announced that any CBD oil, drink or treat without its regulatory approval will be “taken off the shelves” by March 2021.

To remain retailers, all CBD companies producing such goods must apply for a novel food authorization by March 31, 2021. CBD cosmetics, vaping products, and medicinal extracts will remain exempt from the novel foods enforcement.

Following ten months of preparation, Mile High Labs submitted its application this Monday, April 20.

“This application was more complicated than usual because of the complexities associated with hemp-based products,” Wendi Young, the company’s vice president of regulatory and compliance, wrote in a press statement.

To become approved, a CBD producer will be evaluated on its lab standards, regulatory compliance, and the state of its equipment used for testing. To comply with these assessments, Mile High Labs’ application detailed its labelling commitments, hemp biomass intake controls, testing requirements, and specifications for both its CBD isolate and finished products.

“It was necessary for us to address all of the concerns expressed by various regulatory agencies,” Young wrote. “We collaborated with experienced consultants from the UK to guarantee that our application met the expectations of both the EFSA as well as the FSA.”

Some of these consultants were from the ACI, which has now urged other CBD companies to follow in Mile High Labs’ footsteps and submit their application in time.

“The FSA expects all companies operating in the UK CBD industry to demonstrate that their products are safe for human consumption. Getting a novel foods dossier validated is the way a company does this,” Dr Parveen Bhatarah, the ACI’s regulatory lead, said in a statement.  

“Although 31st March 2021 is the deadline for novel food application validation, if companies do not have appropriate stability data or toxicological data then time is running out. The ACI will support companies that do not have the relevant in-house regulatory expertise.”

A deadline not to be missed

While the FSA’s intervention has been welcomed by many in the UK’s CBD sector, others have been more sceptical.

“The novelty status of CBD was a blow for the industry, which had hoped that by not making medical claims, manufacturers would be free to sell their products as supplements without significant regulatory constraints,” Sarah Ellson, a regulatory partner at the European law firm Fieldfisher, said in February.

“The reality of getting authorisation for a novel food from the FSA and EFSA is burdensome and involves a dossier of scientific data that may seem similar to getting a medicine authorized.”

The Cannabis Trades Association, another UK CBD industry group, has also taken issue with the interpretation of CBD as a ‘novel food,’ but has stated that it will support regulations that ensure consumer safety.

“While [the FSA’s announcement] may be frustrating,” Ellson continued, “it should be remembered that the rules are set in the interests of public safety, and that attempting to sidestep or antagonize regulators could have serious consequences for individuals, companies, and the CBD industry as a whole.”


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