The soy industry is reeling after the European Food Safety Authority (EFSA) rejected for the third time a soy-cholesterol reduction health claim submission – even as authorities in 10 countries have backed similar claims.
The three soy groups involved are still poring over the opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) but issued a preliminary statement expressing surprise at a verdict they say was formed while discounting a number of crucial meta-analyses.
A spokesperson for the European Natural Soyfoods Manufacturers Association (ENSA) said it, along with the two other groups behind the submission – the Soya Protein Association (SPA), the European Vegetable Protein Federation (EUVEPRO) – were considering all options and did not rule out a legal challenge.
“The applicants are therefore surprised that, when weighing the evidence, the NDA Panel did not consider that soy protein has a significant cholesterol-lowering effect and concluded that a cause and effect has not been established between soy protein and the reduction of blood cholesterol concentrations,” the three groups wrote.
“The applicants are in particular concerned that the NDA Panel did not include a number of meta-analyses in the body of evidence. The applicants are currently assessing the EFSA opinion in more detail in the view of submitting comments to the Commission in accordance with Article 16.6 of [the nutrition and health claims regulation] and considering all legal options.”
The soy industry was first rebutted by the NDA in 2009 and 2010 when it refuted article 13 (general function) and article 14 (disease risk factor reduction), that sought to link soy constituents and cholesterol reduction.
Working with its consultant, Janice Harland from HarlandHall Associates, the groups refined the article 14 claim to focus on all components of soy rather than the initial soy isoflavone-centric rejection in 2010, and had the benefit of ‘stop-the-clock’ pauses to address NDA concerns on both occasions.
Speaking with NutraIngredients this morning, a disappointed Harland questioned the stop-the-clock procedure. “It does not work because it does not address the genuine concerns the NDA panel might have with an application.”
“But nothing the NDA panel does surprises me. It has to be asked how the science and claims that are accepted in so many other countries can be rejected by the NDA? Will there be another application? I don’t know – you’d have to ask the soy industry that.”
The NDA rejected 10 of 11 meta analyses because they, “were not designed to assess the effects of ISP (isolated soy protein) but rather of isoflavones or of soy protein from different sources, including soy foods, on blood cholesterol concentrations”.
Another six randomised clinical trials were deemed irrelevant because they used whole foods. “The Panel notes that the macronutrient and fibre composition of whole soy foods, which might have had an impact on the claimed effect, differs from the macronutrient composition of ISP for which the claim is made, and considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim on ISP.”
It also discounted trial data from another 19 trials because they were subject to a, “high risk of bias owing to methodological limitations”.
Rat data was deemed irrelevant because of, “differences in lipid metabolism”.
The panel concluded: “In weighing the evidence, the Panel took into account that under similar conditions four RCTs reported an effect of ISP on blood LDL/non-HDL cholesterol concentrations, whereas 14 RCTs did not report such an effect, and another RCT showed no consistent effects. The Panel also took into account that most of these RCTs were at high risk of bias, that differences in the results obtained between trials appear unrelated to the dose of ISP used, to sample size or to study duration, and that the evidence provided in support of a possible mechanism was not convincing.”
Soy-cholesterol lowering claims are approved in Japan, the US, the UK, South Africa, the Philippines, Brazil, Indonesia, Korea, Malaysia and Turkey.