CBD’s novel foods uncertainty: Lively NPD may be at risk, notes food law expert

28 Feb 2019 --- While the EU production and marketing of food products derived from Cannabis sativa L. has been considerably restricted since cannabidiol (CDB) food products were recently declared to be unauthorized novel foods, not all cannabis-derived food products require this authorization. This is according to insights shared by Karin Verzijden, an Attorney-At-Law at Axon Lawyers, with a specialization in food legislation. Within this shifting regulatory space, companies are continuing to enter a market that has been “flourishing” such as US-based CannAmerica Brands. The company notes that it is used to a “reactive regulatory environment” and is optimistic the company is primed to operate in the EU market.

The EU market for CBD has been enjoying a boom, according to Verzijden. “A variety of CBD nutraceutical products is being offered for sale, such as HempFlax CBD, CBD oil, but also CBD-infused tea, honey and sweets. Although there is no hard scientific evidence, many health benefits are connected to CBD food products, such as stress reduction, good night rest, providing energy and increasing resistance,” she adds.

However, the regulatory status of CBD is somewhat complicated in the EU as it has recently been categorized as an unauthorized novel food. 

Novel food or not?
A “novel food” is defined as food that has not been consumed to a significant degree by humans in the EU before May 15, 1997. A history of the consumption of CBD has not been demonstrated. Following CBD’s classification, Verzijden notes that the lively trade in CBD food products may be at risk. 

However, one current pending application for a CBD food supplement and the transition regime laid down in the Novel Foods Regulation could prove important to companies operating in this space, she continues. 

The pending application is from Cannabis Pharma (Czech Republic) and a European Food Safety Authority (EFSA) opinion is reportedly coming next month. The outcome could be vital as it could open doors for other CBD food supplements, as they do not rely on data protection, she explains. Any other company that can meet the conditions of use stated in the authorization of the Cannabis Pharma product would be at liberty to market CBD food supplements as well.

Regarding the transition regime, she continues: “Any product that did not fall within the scope of the former Novel Foods Regulation was lawfully marketed prior to January 1, 2018, and for which an application for market authorization is filed before January 2, 2020, can continue to be marketed until an authorization decision has been taken. While this transition period is in principle drafted for Novel Foods that fall into one of the new novel food categories under the new Novel Foods Regulation, it is in the spirit of the transition regime to also include the CBD scenario.”

“The deadline for submitting a Novel Food application is January 2, 2020. In principle, companies that have not filed an application yet do not immediately have to be removed from the market, provided they seriously plan to file one. Also, it should be mentioned that enforcement is a Member State affair. It may be that there are variations in enforcement from country to country within the EU,” she tells NutritionInsight.

The entrance of US companies to the market: What next?
CannAmerica Brands and Winchester intend to enter into a definitive agreement by April 15, meaning the companies will be “poised to provide regulatory-compliant CBD.”

CannAmerica Brands is a US marine veteran founded and operated a portfolio of cannabis brands with licensing agreements in the US states of Colorado, Nevada and Maryland. Winchester is a Europe-based arms-length entity that operates a revenue-producing online retailer under the brand HempElf and offers a variety of CBD products through its store. 

Regarding how CannAmerica plans to operate within this turbulent regulatory space, Anglin notes that the company has no intention to export CBD-infused finished products to Europe. Instead, CannAmerica’s partnership with Winchester MD is designed to create the products in Europe for distribution.

“CBD products derived from hemp have been in the European market for years and are sold in multiple outlets across Europe. It appears that – similar to the US market – the entirety of Europe is experiencing very high consumer demand, with seemingly unlimited growth potential for hemp products,” Dan Anglin, CEO and Co-Founder of CannAmerica Brands, tells NutritionInsight.

“The issue of CBD-based food products being readily available across all of the EU and the UK will get resolved based on consumer demand and our position is to establish the brand in countries and regions where the products are currently allowable. This is while we wait for the EU and individual governments to create sensible policies for consumers to access all of the products they demand,” he says.

“By establishing operations with our partner in Europe, we will be poised to provide consumers with regulatory-compliant products the moment they are approved. Additionally, as one of the original regulated cannabis operators in the US, our experience navigating ever-changing complex rules and regulations gives us an advantage over companies that are not used to a reactive regulatory environment,” he adds.

Anglin expects to see continued access and acceptance of CBD as a product for dietary or nutritional supplements. 

It will take many years before CBD products will be available as products that can make health claims, as that requires rigorous testing for approval, he admits. “Given the demand and interest of consumers across the world, that is the direction this is headed, it’s just a matter of when,” he stresses, however.

Importantly, Verzijden clarifies that any US companies active in the EU market will have to comply with EU rules. 

Although a “flourishing” market may be at risk, there is scope for interested actors, particularly in the period following the EFSA opinion on Cannabis Pharma’s application.

A detailed article on the current US regulatory position around CBD will appear in the March issue of The World of Food Ingredients. 

By Laxmi Haigh