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06/14 Cinnamon capsules to reduce blood sugar are medicinal products!

Food supplements and dietetic foods with high levels of cinnamon or cinnamon extract have been on sale for some time now in Germany. Amongst other things, they are said to reduce the blood sugar level in type II Diabetes mellitus. Both the Federal Institute for Medicinal Products and Medical Devices (BfArM) and the Federal Institute for Risk Assessment (BfR) are of the opinion that products marketed with a claim of this nature should be classified as medicinal products and required to seek marketing authorisation. During the marketing authorisation procedure the efficacy, safety and pharmaceutical quality of a medicinal product are examined. Food supplements and dietetic foods, by contrast, are not required to obtain marketing authorisation. Hence, there is no examination of their quality, efficacy or safety nor is any scientific risk-benefit analysis undertaken. Cinnamon-containing dietetic foods to reduce blood sugar have now been classified by the courts as medicinal products. They cannot, therefore, be marketed as foods. Both these products and cinnamon-containing “food supplements”, which are sold without any health claims, vary considerably when it comes to their coumarin contents. The results of official food control reveal that some products contain so much coumarin that the recommended daily dose already exceeds the tolerable daily intake (TDI). BfR believes that products of this kind are harmful.

Food supplements are foods. They are intended to supplement a diet with doses of substances with a specific nutritional or physiological effect. In the case of cinnamon products bearing the claim “that they reduce blood sugar”, by contrast, it is suggested that cinnamon and its ingredients have a therapeutic effect, i.e. are intended “to heal, alleviate, prevent or identify diseases, suffering, physical damage or pathological disorders” (§2 Drugs Act). Health-related statements and claims of this nature are not admissible for foods or dietetic foods but are restricted to medicinal products.

Furthermore, there is no scientific evidence that cinnamon or cinnamon products can have a positive effect on the blood sugar level of diabetics. Up to now, no other studies have unequivocally confirmed the results of a study from Pakistan. Cinnamon has not been granted marketing authorisation as a plant medicinal product for the treatment of diabetes in Germany or Europe. Hence, there has been no examination of the quality, efficacy and safety of cinnamon in conjunction with blood sugar reduction. Nor has there been any monitoring of possible side-effects.

BfArM and BfR believe that the regular taking of large amounts of cinnamon in the gram range, something that is recommended to diabetics by the general press and seemingly even by some doctors, is harmful. Potential active principles have not been standardised. It is not known whether the long-term taking of products of this kind will lead to adverse reactions.

Furthermore, the ingredient, coumarin, contained in cinnamon can cause damage to and inflammation of the liver when higher doses are taken over a longer period by sensitive individuals. The cassia cinnamon used in food supplements and dietetic foods - particularly cinnamon powder products - sometimes contains high levels of coumarin,. This was shown by tests of the monitoring authorities of the federal states. Some of the cinnamon products examined contained so much coumarin that the recommended daily dose would already exceed the tolerable daily intake (TDI) of 0.1 milligram coumarin per kilogram body weight (the TDI values indicates the amount of a substance that can be ingested daily over a lifetime without any adverse health effects). As the consumer also ingests coumarin from other sources like cinnamon-containing foods and cosmetics, damage to health cannot be ruled out from the long-term taking of products with a high cassia cinnamon content.

“Diabetics who ingest large amounts of cinnamon powder or cinnamon products daily on the advice of a few doctors of as part of a diet plan should not take these products because of the possibly high coumarin contents and the inadequately proven efficacy”, says the Director of BfArM, Professor Dr. Reinhard Kurth. The German Diabetes Society (DDG) also advises against taking cinnamon products. “Consumers who ingest large amounts of cassia cinnamon powder or cassia cinnamon products for other reasons, for instance to improve digestion, should not take these products either”, advises the President of BfR, Professor Dr. Dr. Andreas Hensel.

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