In July EFSA rejected Probi’s article 13.5 health claim stating “Lactobacillus Plantarum 299V increases non-heme iron absorption” because of “insufficient” evidence.
It said evidence for the effect was “inconsistent” and “at risk of systematic bias” addingthere was “no evidence” for a plausible mechanism in vivo in humans.
At the time Probi said it would not take the rejection as the final word on the dossier.
Yet the company’s CEO Peter Nählstedt told us that if it failed to overturn the rejection it would have to assume it is impossible to secure a health claim for probiotics given its claim was the 310
The company has now followed through on its initial reaction by writing to the Commission about its objections.
“We strongly question the way this opinion has been treated by the [EFSA] panel. The absence of qualified scientific evaluation, on several occasions, of the information submitted to the panel, is to us highly unsatisfactory,” the company wrote in the letter sent to the Commission at the end of August and now forwarded onto EFSA.
The Commission told EFSA: “Before considering further steps on this matter, and given that the above-mentioned comments relate to scientific matters for which EFSA is responsible, we would like EFSA to examine them, and let us know whether they are likely to modify the conclusions of the relevant opinion.”
Speaking with us this week about the development Nählstedt said: “Probi does not agree with the EFSA panel’s conclusion that a cause and effect relationship could not be established. Therefore we do wish to see that the case is re-considered by the Commission.”
Against all odds?
Yet – as with the likelihood of a probiotic claim approval – the odds of securing any changes from EFSA are against Probi.
NutraIngredients understands there have only been two occasions when EFSA has changed a claim opinion after publication: once because of an administrative oversight after which the weight loss claim was still rejected and a second time for a reworked submission after an initial rejection of a claim for prunes and bowel movement.
Yet Probi says its grounds for a challenge are solid.
It told the Commission that four out of the six of the studies submitted showed an effect on non-haem iron absorption and added the remaining studies should be considered as “clearly supportive” of the claimed effect.
It agreed that results from two of the studies were different, but said it had explained this was because the bacteria used was not in a “comparable active state” with the second study using a bacteria added lyophilized to a cold product with a low pH.
Yet it said EFSA did not acknowledge this explanation.
Probi also questioned EFSA’s statement that one of the studies had methodological limitations because the “test and control foods differ in characteristics other than the Lp299v content which may have affected non-haem iron absorption”.
EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel said “the relative effects of Lp299v vs differences in organic acids on non-haem iron absorption have not been quantified”.
Yet Probi said it did not understand why there was no scientific evaluation of the potential effect of the differences in organic acids content on iron absorption, “rather than just a statement”.
“We furthermore find it strange that the ‘methodological limitations’ claimed by the panel were not specified – if other than differences in organic acids - and to what extent it affects the overall assessment of the study.”
Probi says these concerns were not raised in the first or second stop-the-clock procedure meaning the issue could not be addressed before the claim was rejected.
The NDA panel also criticised the order in which the probiotic and placebo products were given to the participants as opening up the “risk for systematic bias”.
Yet Probi said it gave EFSA proof that this had not had a carry-over effect, with results from randomised studies showing the same difference in the amount of iron absorbed regardless of the order.
“This information was not considered in the opinion by the panel and, again, we strongly question the way this opinion has been treated by the panel,” Probi wrote to the Commission.
“A qualified scientific evaluation would most likely have resulted in the conclusion that an order effect would, if anything, result in a lower absorption of iron on the second occasion.”
EFSA did not respond to our request for comment in time for the publication of this article.
Second claim castoff
This isn’t Probi’s first experience of claim rejection.
In 2010 EFSA rejected its health claim application for a probiotic strain and a decrease in potentially harmful pathogens in the gut.
There are currently no approved claims for probiotics in the EU – and the term ‘probiotic’ itself is considered an unauthorised health claim and therefore forbidden on pack.
Most EU manufacturers now list strains on pack and leave consumers to draw their own health conclusions.
Record quarter sales
The first nine months of 2016 also produced growth of 39% compared to the same period last year.
The company also announced the completion of its acquisition of US probiotic player Nutraceutix, which went for a preliminary cash price of $105m (€92.41m).