The ruling, made by the North Rhine-Westphalia Senate, rejects the unnamed defendent's appeal against the Düsseldorf Administrative Court’s decision, which ruled an absence of evidence of CBD consumption before 15 May 1997 reinforces its status as a novel food.
The defendant’s argument extended to accusations that the Commission had changed its assessment and they were entitled to at least a transition period to exhaust stocks.
However, the Senate disagreed arguing that the defendant should have known about the unclear position of CBD and protection of consumers takes precedence over other considerations.
The Senate added that even if the starting material was not novel, there must be evidence of safe consumption for the final product as well to exclude novel food status.
‘Not surprising’
“My view is this ruling along with its broader enforcement is not surprising at all,” explains Luca Bucchini, managing director of food regulation specialists Hylobates Consulting.
“Since many assume - perhaps correctly- that isolated CBD and related extracts are here to stay, they may overlook the current legal situation and think food law is not based on a presumption of safety until risks are proven, but it is quite the opposite.
“The confirmation that the Senate, albeit with effects in Germany only, has rejected any notion of a transition period may be a cause of concern,” he adds.
“In some countries like the UK however authorities have not addressed the issue in a timely manner and now have the onus to find a way forward.”
The UK’s stance on CBD’s classification remains unchanged ever since The European Commission (EC) reclassified cannabidiol (CBD) as a Novel Food this time last year.
In its last update on 30 January, 2020, the Agency says, “The FSA accepts the clarification from the EU that CBD extracts are considered novel foods.
“We are committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in the marketplace in a proportionate manner.”
ECJ decision
In more court-related news, the European court of Justice (ECJ) ruled last month that a link must be apparent between a general and specific claim, for example with the use of an asterisk.
The case involved two German firms Dr. Willmar Schwabe GmbH & Co. KG and Queisser Pharma GmbH & Co. KG concerning the alleged misleading packaging of a food supplement.
Schwabe brought an action before the Regional Courts of Düsseldorf, Germany, ordering Queisser Pharma to stop promoting the food supplement as long as the claim in question appeared on the front of its packaging.
Court documents details the marketing of a food supplement by Queisser Pharma called Doppelherz aktiv Ginkgo + B -Vitamine + Cholin, which contains zinc, vitamins B1 (thiamin), B2, B5 (pantothenic acid) and B12 amongst others.
The back of the food supplement’s packaging includes the disputed claim, “B vitamins and zinc for the brain, nerves, concentration and memory.”
Further details revealed that on the reverse side of the packaging, there were claims that read, “Regular mental stimulation and a healthy diet play a role in supporting memory and concentration and the ability to cope with everyday tasks. The metabolism of the brain and nerves is therefore dependent on a good supply of nutrients.”
Further claims
Other claims included, “Vitamin B1 and vitamin B12 contribute to normal energy metabolism and normal function of the nervous system as well as supporting normal mental capacity,” and “Vitamin B1, like vitamin B2, plays a role in normal energy metabolism and the normal function of the nervous system. It furthermore contributes to protecting cells against oxidative stress.”
Commenting on the decision made by the country’s Federal Court of Justice (Bundesgerichtshof), Bucchini explains that the issue concerns litigation between two companies under competition law in Germany.
“The issue is how you can make so-called "general claims" in a compliant manner,” he says.
“General claims are statements such as "for your well being" or "for your sleep" that do not link an health effect to a specific substance.
“The latter are specific health claims and are scrutinised by the European Food and Safety Authority (EFSA).
“EU law foresees that general claims ("for tiredness") are allowed if there is a corresponding specific claim in the vicinity ("magnesium contributes to a reduction of tiredness").
“But how do you define this "vicinity"? Can the general claim be on front pack and the corresponding specific health claim on the back pack only?
“The court's legal expert, the advocate general, had said yes, but the court took a different view,” adds Bucchini.
“They said that, as is common practice, a link must be apparent between the general and specific claim, for example via an asterisk. The ruling validates best practices.”
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The event wants to bring together the science, business and regulation governing CBD to look at how businesses can unlock this important market opportunity. For more details, check out our advanced programmed, and view confirmed speakers, visit the CBD Global Summit website.