In 2013 the UK’s Food Standards Agency (FSA) warned firms using raspberry ketone - the phenolic compounds found in raspberries – it was likely to be considered a novel food under EU law since there was no evidence of its consumption before 15th May 1997. A few months later the FSA confirmed its stance, but after member state consultation it gave exception to extracts prepared using water or 20% ethanol (1:4 ethanol to water).
Separately, raspberry ketone (4-(p-hydroxyphenyl)butan-2-one) is authorised in the EU when used as a flavouring, according to the EU Flavourings Regulation (1334/2008/EC).
Can authorities distinguish legal from the illegal?
A spokesperson for the FSA said: “In order to enforce the novel foods legislation appropriately, enforcement authorities do need to investigate how a raspberry ketone ingredient in a particular food has been produced. If they find that a product is unsafe, they have the powers to take action to protect consumers.”
The authority did not respond to a request for information on how this difference was investigated.
The company Forza Supplements, which sells caffeine and ketone weight loss supplements using the authorised extract, said the decision had caused confusion.
“The raspberry ketone issue is difficult for the authorities to monitor as certain extracts will be novel and illegal while others will be in keeping with the regulation and perfectly fine to sell,” Sam Conebar, research and development manager for the company, told us.
The extracts are often included in weight loss products, although in the EU a health claim application for Rubus idaeas (raspberry) extract - BERI-08 – and thermogenesis production, satiety and consequently weight loss was rejected by the European Food Safety Authority (EFSA) due to a lack of evidence.
He said the company never received an explanation as to why this differentiation was made by the authorities.
Forza’s supplement contains: 200 mg of raspberry fruit powder, 200 mg caffeine, 100 mg Choline and 12 mcg Vitamin K2. The company reformulated as the FSA ruling was going through.
Conebar said the novel food cut-off date was unfair. “There are many foods that have been introduced in recent times by other communities and it is quite ignorant of us to discard them as being ‘potentially unsafe’ when other cultures have eaten them for hundreds and hundreds of years.”
Applying for novel food approval would be expensive and time consuming, he said.
According to the EU’s Rapid Alert System for Food and Feed (RASFF), on 3rd March a batch of food supplements containing the unauthorised novel food ingredient raspberry ketone from the UK passing via Poland was detected by German authorities. Germany picked up another batch as it came from the US via the Netherlands a week later.
Under EU law more specific details on these blocked products was confidential.
As seen in Mail Online
The company came under fire from UK newspaper the Daily Mail last December when it was revealed that 24-year old Cara Reynolds died after taking a large amount of Forza’s Raspberry K2 supplements. The young woman overdosed on the pills just after separating from her fiancé, the Mail Online reported.
The original article quoted a case report submitted to the British Medical Journal (BMJ) which was said to criticise the product’s high caffeine content and over-the-counter slimming products in general.
At the time the BMJ told us it had not published or even received such a report.
The issue reared its head again this month when the report was cited again by the Mail, this time suggesting the case report had been published. The BMJ told us there had still been no report submitted and it had contacted the newspaper again to this effect.
NutraIngredients contacted the newspaper and the second article has since been amended to say that the report was only submitted by the young woman’s doctor as opposed to published, although this is also refuted by the BMJ.
Conebar said his company had chosen not to contact the paper given the sad circumstances the articles referred to.
“It was obviously upsetting to hear that somebody had died while taking our product but we could never have imagined that the press would run with the version of events that they did,” he said.
According to a draft opinion from the European Food Safety Authority (EFSA), it is safe for the general adult population to consume 200 mg of caffeine in a single sitting and up to 400 mg per day.
On its website, the company directed consumers to take two capsules in the morning with breakfast and one with lunch. It advised those who were sensitive to caffeine to "start with" just one capsule a day and said consumers should never exceed two capsules at once or four per day.