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BgVV and BfArM issue warning: Food supplements with AFA algae are no substitute for medical treatment

08/2002, 21.03.2002

Recently, certain food supplements containing AFA algae have increasingly been attributed with healing powers in the press, on the radio and TV, in publications and on the Internet. It s claimed that these products could offer protection against various viral infections like herpes, influenza, chickenpox, mumps and even cancer. The algae products are also said to help with mental disorders like depression or attention-deficit disorders, poor memory or sleep disorders. They are said to considerably improve memory and brain functions. The statement, which has been widely reported in the media and in books that AFA algae products are a "sensible and natural alternative" to medical treatment prescribed by a doctor for certain neurological disorders like attention deficiency disorder (ADD) in children or dementia diseases like Alzheimer's, is cause for particular concern.

The Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV) and the Federal Institute for Medicinal Products and Medical Devices (BfArM) warn that there is no scientific proof for the medical action of such AFA algae products on sale as food supplements. This constitutes a violation of the ban on misleading advertising. There is a risk that, as a consequence of the erroneous information, parents will abandon the necessary medical treatment of their children and that their condition may worsen if they are given AFA algae products instead. The same applies to adults who place their faith in the "healing powers of AFA algae products" to treat diagnosed depression or, in the case of another health disorder, discontinue prescribed medical treatment and instead take AFA-algae products.

Furthermore, the Institutes point out that products which are attributed with healing effects in advertising claims, are to be considered as medicinal products. Consequently, they require marketing authorisation by the Federal Institute for Medicinal Products and Medical Devices (BfArM) or the European Agency for the Evaluation of Medicinal Products (EMEA). If no such marketing authorisation has been obtained, the products may not be placed on the market. No product containing cyanobacteria has been given marketing authorisation as a medicinal product in Germany for the treatment of disease. If such an application for marketing authorisation were to be submitted, extensive proof would be required of manufacturing quality, efficacy in the application applied for and safety. Until such marketing authorisation has been obtained, the taking of AFA algae or other products containing cyanobacteria cannot be recommended for the treatment of ADD.

By contrast, food supplements are foods for general consumption and may not be advertised with medical claims. The manufacturer/distributor is liable for safety. Comprehensive monitoring by the control authorities of the Laender is not possible as these algae products are often distributed directly. In the USA the sale and distribution of blue algae products, which are marketed with therapeutic claims, has been banned.

So-called AFA algae, popularly known as blue or blue-green algae, are cyanobacteria (aphanizomeon flos-aquae). It is known that certain strains of these organisms form toxins which can attack and damage the nervous system. Furthermore, they may be contaminated with other cyanobacteria which produce hepatotoxic toxins (microcystins). Studies in the USA have shown that, depending on when they are harvested, dried algae may contain large amounts of microcystins. Food supplements made from AFA algae may also be contaminated with microcystins (cf. also: http://ehpnet1.niehs.nih.gov/docs/2000/108p435-439gilroy/abstract.html).

According to this American study the content was so high in more than 70% of the samples that, at a recommended daily intake of 2g algae, the tolerable upper intake level was, in some cases, considerably exceeded. As food supplements are consumed daily over a longer period, it cannot be ruled out that the chronic burden on the organism imposed by such large levels of microcystin will constitute a risk to health.

BgVV, therefore, recommends that children in principle should not consume AFA algae products. It is recommended that adults restrict their consumption of AFA algae products. There is no scientific evidence to support any benefits from the consumption of products containing AFA algae.

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