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The Czech Agriculture and Food Inspection Authority (CAFIA) has detected the presence of sildenafil, an unauthorized medicinal substance, in two batches of food supplements.
CAFIA ordered the inspected entity to stop placing the food on the market and to take the product back from consumers if a customer contacts it for this purpose.
The inspected entity stated that it had supplied the food in question to five wholesalers, who, according to the communication provided, did not have the non-compliant batch or any other batches of the product in stock. End consumers were informed by means of information notices placed on the entrance doors of the retail outlet and on the sales counter inside the premises.
Laboratory analysis carried out at a CAFIA-accredited laboratory confirmed the presence of sildenafil in both products. Sildenafil is an active substance found in medicinal products intended for the treatment of erectile dysfunction or high blood pressure in the pulmonary blood vessels. Products containing sildenafil are available only from pharmacies and exclusively on prescription.
For this reason, CAFIA submitted both samples for expert assessment by the National Institute of Public Health (NIPH). In view of the amount of the active substance detected in the recommended daily dose, the NIPH assessed the products as posing a high health risk to sensitive or not fully healthy consumers. Both foods were assessed as injurious to health pursuant to Article 14 of Regulation (EC) No 178/2002 of the European Parliament and of the Council due to the presence of the active substance sildenafil at a level corresponding to a therapeutic dose.
Food supplements are foods that represent concentrated sources of vitamins, minerals or other substances with a nutritional or physiological effect. As they are foods rather than medicinal products, they must not contain medicinal substances.
CAFIA strongly recommends that all consumers who have the products concerned at home do not consume them as a precautionary measure.
Article by: Bc. Marek Bartík, Media Communications Officer