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Femarelle® and bone mineral density - Scientific substantiation of a health claim related to “Femarelle®” and “induces bone formation and increases bone mineral density reducing the risk for osteoporosis and other bone disorders” pursuant to Article 14 of the Regulation (EC) No 1924/2006 - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies
No abstract available
Following an application from Se-Cure Pharmaceuticals Ltd. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Austria, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Femarelle® and induces bone formation and increases bone mineral density, reducing the risk for osteoporosis and other bone disorders.
The scope of the application was proposed to fall under a health claim referring to disease risk reduction.
The food/constituent for which the claim is intended, Femarelle®, is a mixture of DT56a soy derivative and ground flaxseed at a ratio of 3:1, for oral administration. Each capsule contains 344 mg soy and 108 mg flaxseed – altogether 430mg powder. The applicant states that the active component responsible for the claimed effect is the DT56a soy derivative. No information is provided on the composition of the final product with regard to components pertinent to the claimed effect, e.g., isoflavones. The composition of the flaxseed component is not described.
The Panel considers that the food/constituent for which the claim is made, i.e. Femarelle®, has not been sufficiently characterised.
The applicant claims that Femarelle® induces bone formation and increases bone mineral density (BMD) reducing the risk for osteoporosis and other bone disorders among post-menopausal women. The target population for the intended health claim is menopausal and postmenopausal women.
The Panel considers that the development of osteoporosis may be influenced by diet and reducing the risk of osteoporosis is beneficial to health.
The data submitted to substantiate the health claim relate specifically to studies on Femarelle® and DT56a. The data that are considered pertinent to the health claim consist of one non-controlled intervention study in humans, three studies in rats, and one in-vitro study.
The intervention study compared the effect of two intake levels (644 mg/day or 344 mg/day) of DT56a soy derivative on BMD in postmenopausal women. A significant difference between the two treatment groups for the change in BMD over the 12 month intervention period was observed for the lumbar spine (BMD increased in the group receiving 644 mg/day) but not for the femoral neck.
The Panel notes that there were significant weaknesses in this study. Furthermore, it was not possible to determine whether the substance fed to the subjects was the same as that for which the claim is made (Femarelle®). No effects of the intervention on either bone formation or the risk of osteoporotic fractures were assessed in the study. The Panel considers that the weaknesses of this study greatly limit its value as a source of data to substantiate the claimed effect.
The Panel considers that the animal and in vitro studies presented do not provide sufficient evidence to support a bone formation effect of DT56a in vivo.
No data regarding other bone disorders have been provided in the application.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Femarelle® and increased BMD, increased bone formation, or decreased risk of osteoporosis or other bone disorders in post-menopausal women.
Bone formation, bone mineral density, osteoporosis, post-menopausal women