“Obviously science costs money. Marketing costs money, too, and there are quite a few companies where the marketing budget is larger than the scientific budget. And perhaps that is not always such a good idea,” said Henk van Loveren, professor of immunotoxicology at the Dutch National Institute for Public Health and the Environment (RIVM) and a member of European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA).
“If you want to do science and if you want to have a scientific basis for a claim, then you need to have the data, and it costs money if you want to do the studies,” he added.
Prof van Loveren spoke to NutraIngredients during the International Probiotics Association’s World Congress here in Miami. He stressed that his views are his alone, and not necessarily those of EFSA, the EC or the RIVM.
Probiotics have failed more than most in the search for a positive opinion from EFSA. No probiotic strain has yet received a positive opinion. And this has spurned frustration and discontent amongst industry and academia.
“I understand the unrest,” said Prof van Loveren. “If I were a company making a lot of money from some claim and then all of a sudden it needs to be different and you cannot bare this claim anymore because it hasn’t been substantiated, then you have a problem for your company. I can understand that.”
“On the other hand, I think it is a bit cynical and unethical to have people pay for what that they think are good products, because there is marketing going on saying that some probiotics are very good for you, but it’s not set that it’s all true or not,” he said. “People are paying for things that they think are beneficial to them, and maybe they’re not. I don’t like that.”
Success to come
Despite the failure of probiotics, and prebiotics, to achieve a positive opinion from EFSA, Prof van Loveren rejects allegations that it is too difficult to achieve a health claim for these ingredients.
“I think it’s a matter of time,” he said. “To me, and [based on presentations we have seen at this IPA World Congress], there is a lot of data out there to show that there are effects.
“To me scientifically, that is also logical: The bacteria interact with the immune system, and products from microbiota can steer the immune system. What I’ve heard [at the congress] is that there are actually some studies on bacteria that I would like to see show up in dossiers.”
Closed doors, Ivory Towers
Another complaint levelled at EFSA is the lack of dialogue, and Prof van Loveren expressed his sympathy for such comments.
“I think it’s a fair comment that the process that is followed is more or less it is an Ivory Tower. There is a dossier and the company doesn’t hear until it’s almost published,” said Prof Loveren. “As a company I would be upset, too. I am not stating the EFSA or the European Commission line here; I’m just expressing my own feelings. Yes I would be upset as a company if I had invested quite a lot of money in doing studies and have no communication or hardly any communication with the people doing the evaluation.”
Prof van Loveren said that this is changing and that moves are being made to ask questions much earlier on in the development of the opinion, and to ensure there is some communication with the company. He admits that this is still retrospective, however.
“I sense it is not going fast enough for industry, and there I have a little bit of feeling for them,” he said.
EFSA’s NDA panel announced the first round of its article 13.1 opinions in September 2009 and a second batch in February this year. On both occasions no positive opinion was issued for probiotic-based health claim opinions, with more than 280 dossiers rejected, mostly because the strains were deemed not to be sufficiently characterised.
Commenting on the 13.1 claims, Prof van Loveren is adamant the decisions were correct, noting that many of the submissions were “fragmented”. “Article 13.1 is not a dossier like you get with a 13.5 or 14, where it is much clearer and it’s spelled out what an applicant wants,” explained Prof van Loveren.
“Sometimes all we get is a line of the health claim that we’re supposed to evaluate, the wording – sometimes a few different options of the wording that they would like to adhere to – and a bunch of papers,” he said. “Sometimes the papers didn’t even refer to the claim that was made. We very often had to really think what was meant by the claim, so we needed to almost interpret rather than having a very crisp clear idea of what the claim was.”
Prof van Loveren also notes that the nature of the claim for probiotics was often not clear. “Reducing cholesterol is an easy claim,” he said “but general health and well-being, or a healthy microbiota, that sort of thing, that is much more difficult because nobody knows what a healthy microbiota is.”
“So we had to really think of what was meant by the article 13.1 claims.”
Article 13.1 claims are composed and submitted by Member States. Prof van Loveren said that the “hope was that the national governments would do some kind of initial screening and to take out what was irrelevant or not good enough,” before they were submitted to EFSA.
“The member states shouldn’t do a pre-evaluation but they should screen the 13.1 list to make sure only relevant things were there,” explained Prof van Loveren.
And did it work?
“Some governments did that, but some didn’t. I’m not sure which governments did or did not, but I believe Finland did well, for instance,” he said.
Articles 13.5 and 14
Following the negative opinions for article 13.1 many health claims observers noted dossiers were already being reworked for presentation via article 13.5. Companies like Provexis have also shown that positive opinions can be achieved (not for a probiotic but for a tomato extract), and that you don’t have to be a multinational to do this.
“Of course, achieving a positive opinion can be done,” said Prof van Loveren. “I don’t say it’s easy, but it can be done. You just have to do the state-of-the-art type of studies, and those can be done.
“It should also be true, and that is not always the case: We do get applications that, even if the structure is OK and the writing is done professionally, you get the feeling that even the company has some doubts itself.
“We evaluate based on a good quality standard scientifically, that’s true. We are not easy, that’s true, but science is like that: If it’s not convincing then it’s not convincing. But it can be convincing as [companies like Provexis] have shown,” he added.
The road to success
And Prof van Loveren stated he was impressed by some of the presentations at the IPA congress, noting that, for instance, evidence for certain probiotic strains to counter C. difficile was “very convincing”.
The rules are also clear as to what is expected in a dossier, he said, with EFSA basically abiding by rules outlined in the PASSCLAIM document made by ILSI a couple of years ago.
“Mechanistic studies, for example are not a clear criteria,” said Prof van Loveren. “They help to understand the plausibility, but if you have a good intervention study – well powered, primary outcomes well shown, perhaps with circumstantial evidence to support this – then you are already far ahead.
“But open studies, or animal studies, or studies with bacteria that are close but not the same, that sort of thing, that is not good enough,” he added.
“There is always a little criticism of any study, we are all scientists and we know that that is almost always the case,” said Prod van Loveren. “But in the end you have to have good science.”
“For panel members it would be much nicer to have a positive opinion than a negative opinion. It’s no fun to say no, no, no all the time because the science is not good enough or is not convincing. It’s not fun at all.”
The views expressed by Prof van Loveren do not represent the views of EFSA or the RIVM.