Brussels, 22 August 2017 – The European Natural Soy and Plant-based Food Manufacturers Association (ENSA) and the European Vegetable Protein Association (EUVEPRO)  are pleased to see that the benefits of soy protein on coronary heart disease have been further confirmed by the US Food and Drug Administration (FDA), which has recognized the scientific evidence supporting such benefits.

On 28 July 2017, the FDA has published a proposal to amend the health claim regarding the relationship between soy protein and reduction of risk of coronary heart disease, converting it into a qualified health claim. Qualified health claims are approved and supported by scientific evidence, however they do not meet the significant scientific agreement standard as authorized health claims do.

The FDA opinion indirectly supports the health claim recently approved by Health Canada regarding the relationship between soy protein and reduction in blood cholesterol.

Meta-analyses published over the last years consistently demonstrate the hypocholesterolemic effect of soy protein.[i] [ii] [iii] [iv] [v]

Moreover, soy foods also have a beneficial fatty acid composition, low in saturated fat and containing polyunsaturated fat, which makes them fit in a healthy and balanced diet.[vi]

In July 2017, the FDA approved also a qualified health claim for soybean oil and reduction of risk of coronary heart disease.

The American Heart Association (AHA) recently published a review regarding dietary fats and cardiovascular diseases.[vii]

In its conclusions, AHA strongly agrees that reducing the consumption of saturated fats and replacing them with unsaturated fats, especially polyunsaturated fats, lowers the incidence of cardiovascular diseases. The replacement of saturated with unsaturated fats lowers LDL-cholesterol, a cause of atherosclerosis. The AHA recommends to make this shift as part of an overall healthy diet.

In Europe, EFSA rejected the proposal for a health claim on soy protein lowering cholesterol.

In countries, such as Canada and the USA, mechanisms are in place to communicate more effectively to consumers regarding health benefits of foods, such as the support that soy protein can provide towards maintaining healthy cholesterol levels which is denied to consumers in the European Union.

ENSA and EUVEPRO regret that the EFSA approach to evaluating health claim applications still fails to accommodate grades of scientific evidence that are applicable to real foods.

[i] Tokede OA, Onabanjo TA, Yansane A, Gaziano JM, Djousse L. Soya products and serum lipids: a meta-analysis of randomised controlled trials. Br J Nutr 2015;114:831-43.

[ii] Yang B, Chen Y, Xu T et al. Systematic review and meta-analysis of soy products consumption in patients with type 2 diabetes mellitus. Asia Pac J Clin Nutr 2011;20:593-602.

[iii] Harland JI, Haffner TA. Systematic review, meta-analysis and regression of randomised controlled trials reporting an association between an intake of circa 25g soya protein per day and blood cholesterol. Atherosclerosis 2008;200:13-27.

[iv] Reynolds K, Chin A, Lees KA, Nguyen A, Bujnowski D, He J. A meta-analysis of the effect of soy supplementation on serum lipids. Am J Cardiol 2006;98:633-40.

[v] Anderson JW, Bush HM. Soy protein effects on serum lipoproteins: a quality assessment and meta-analysis of randomized, controlled studies. J Am Coll Nutr 2011;30:79-91.

[vi] Jenkins DJ, Mirrahimi A, Srichaikul K et al. Soy Protein Reduces Serum Cholesterol by Both Intrinsic and Food Displacement Mechanisms. J Nutr 2010;140:2302S-11S.

[vii] Sacks FM, Lichtenstein AH, Wu JHY et al. Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Circulation 2017;CIR.


For any questions please contact:

ENSA Secretariat

Tel:  32 2 741 62 15




Tel: +32 2 761 16 50