EC calms multi-nutrient claim talk by rejecting fertility & weight aid applications
The EC’s negative decisions for Laboratoire Nurilia’s fertility supplement Condensyl and Laboratoires Nutrition et Cardiométabolisme’s (LNC) weight loss drink Stablor are in stark contrast to the institution’s decision last week to press ahead with a first health claim for combined effects of nutrients.
In evaluating the synergistic effects of nutrients, the EC reasserted the complexities of achieving a health claim commenting, “On the basis of the data presented a cause and effect relationship has not been established between the consumption of Condensyl and the reduction of sperm DNA damage in the context of reducing the risk of male infertility”.
“Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.”
Stablor’s EFSA run-in
The writing was on the wall for French-made Stablor, whose makers suffered previous rejection last year with EFSA critiquing one human clinical trial, and rejecting LNC’s other supporting evidence.
The product, a drink powder containing a mix of proteins, vitamins and minerals, with a patented mixture of tryptophan and neutral amino acids, claimed to aid in the weight management process.
LNC asserted, “In the context of a well-balanced diet and a mild caloric restriction, the addition of Stablor contributes to decrease visceral fat while preserving lean mass in overweight or obese subjects with abdominal fat and cardiometabolic risk factors”.
Condensyl’s makers, Laboratoire Nurilia, a fertility and nutritional supplement firm focusing on fertility, maternity, and hormonal balance, fared little better with the Scientific Panel at the European Food and Safety Authority (EFSA) in 2017.
Here, the Panel concluded that a cause and effect relationship had not been established between the consumption of Condensyl and reduction of DNA sperm damage in the context of reducing the risk of male infertility.
The EC subsequently responded in kind voiding the firm’s claim that “the combination of opuntia fruit dry extract standardised in quercetin and betalain, N-acetyl cysteine, zinc, vitamin B3, E, B6, B2, B9 and B12 in Condensyl decreases sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index)”.
“High sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index) is a risk factor for male subfertility/infertility.”
Combination health claim granted
In our report, which described the EC’s decision to proceed with a combined nutrient health claim, hopes were raised as to the implications of the decision as industry insiders believed this was the start of a new approach to gaining EC approval.
“In the past you would tell companies “forget about a product (i.e. combination) health claim,” said Hylobates Consulting managing director Luca Bucchini.
“Now there is a little hope that studies on combination of ingredients make sense. It's easy to understand that is easier to come up and patent a combination of substances than a new substance, which also may have a novel food problem.”
In commenting on the EC’s latest decisions, he added, “EFSA had delivered a negative opinion, and the EC's decisions follow seamlessly from those scientific opinions.
“It took little more than a year from EFSA's opinion to the formal EC rejection. Whether it is a combination or a single substance, it is very hard to get a positive opinion from EFSA.
“In the case of Stablor, EFSA had concluded that only one study was adequate, and that study did not show an effect.
“In the case of Condensyl, EFSA was unhappy with all the studies, because of the design and the study population. In general these rejections include some applications which did not seem very likely to succeed in the first place.
“However, the key fact that getting a positive opinion from EFSA is a very difficult exercise is unchanged; and, in general, very strong dossiers are necessary, but still do not guarantee success.”
