Provexis' tomato extract supplement use approved by EFSA

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found causality between consuming water-soluble tomato concentrate (WSTC) and a reduction in platelet aggregation under the new conditions of use proposed by the company for its blood circulation-benefitting tomato extract, Fruitflow.

The UK functional ingredients and technology licensing specialist became the first company to win an approval for a European Union article 13.5 emerging and proprietary science health claim for the tomato extract in May 2009, which was subsequently adopted by the Commission in December of that year.

In April this year, the company submitted an application to EFSA for an extension of that authorised health claim to allow for additional proposed conditions of use for the Fruitflow extract to dietary supplements from powdered single-serve sachets to tablets to capsules.

EFSA said that the application was required to address an oversight in the original dossier for the authorised health claim, which had failed to specify dietary supplement format in the conditions of use for the blood flow technology and meant it was only currently only applicable for use in fruit juices, fruit flavoured drinks and yoghurt drinks.

Steve Morrison, chief operating officer at Provexis, told NutraIngredients.com that the firm welcomed the relative expediency of the application but he said it was frustrating that a procedure does not exist under article 13.5 to circumvent the need to resubmit another dossier for extended conditions of use when supporting data already exists.

“The human intervention studies submitted in the original health claim application supported the use of Fruitflow in other categories of food and dietary supplements and we assumed that it was just a matter of EFSA using that data as a reference to allow its use in capsules, sachets and tablets.​​

However, we were told that as we did not specify dietary supplement application in the conditions of use, the onus was on us to submit a new dossier, with the standard five month timeline applying.”​​

Morrison said that the company did not submit any new data to the Parma-based agency in the subsequent dossier but adapted the original application, carefully highlighting the relevant clinical studies, and along with further consultation with EFSA, had approval in three months.

He added that Provexis, having the only product approved under article 13.5, is charting a path in this regard, and thus he cautions other applicants to not expect the NDA panel to draw its own conclusions from the data in their dossiers:​

“Everything should be spelt out clearly – the health claim process is time consuming and costly, and we have learnt that a company should make every effort to communicate not just present but any potential conditions of use for their products.” ​​

Morrison said that Provexis has been working with its strategic partner DSM on scale up and preparation but he said, pending Commission approval, he could not discuss a dateline for expected commercialisation of supplements using the tomato extract.

In the opinion, the NDA panel found that the bioavailability of potentially active compounds in the tomato extract when administered as powder, tablets or capsules “would not be different from that observed in other food matrices for which the health claim has been authorised such as fruit juices, flavoured drinks or yogurt drinks, as long as these are easily dissolved in water.”​

The Panel stated that, in order to achieve the claimed effect, 3 g of WSTC I or 150 mg WSTC II as powder, tablets or easily dissolved capsules with at least 200 ml of liquid should be consumed daily.

The target population for the water soluble concentrate is adults between 35 and 70 years of age, and the NDA said that there is no basis to restrict the conditions of use to this age range in the adult population.

The opinion can be found here.​