German regulatory body has granted Diapharm the registration for seaweed powder to complement a weight loss diet
The German Federal Institute for Drugs and Medical Devices (BfArM) has granted pharmaceutical consultancy Diapharm, the first traditional herbal registration for a medicinal product complementing a weight loss diet for overweight patients. The seaweed powder with 130 mg of bladderwrack (Fucus vesiculosus) is available in Germany in the form of a plant-based film-coated tablet for the first time.
“Demand for natural plant-based remedies with confirmed indications is constantly increasing,” says Nicole Sibbing, Director of Diapharm. “The ‘green’ shift in consumer preferences is directly related to social changes.”
The recommended dosage for this complementary remedy is one film-coated tablet with water twice a day, two hours before meals. Bladderwrack is a brown algae that is native to the North Atlantic and contains iodine. The recommended daily dose contains up to 210 μg of iodine.
The Fucus preparation is the first traditional herbal medicine with an approved indication as an adjuvant to reduced calorie diet to help weight loss in overweight adults, after serious conditions have been excluded by a medical doctor.
Seaweed-based medicines containing bladderwrack have been used for weight loss in the UK and France for decades. “Herbal medications are often a regional tradition,” explains Dr Rainer Kolkmann from Diapharm. “Something that has been established in one EU country can be virtually unknown in other countries. We consistently take the opportunity to identify such medications and their potential, register them Europe-wide and introduce them to the market.”
The company has already managed the registration and approval of more than 500 such medications in 23 countries. However, Diapharm does not distribute medicines itself. Instead, it licences the registration, including the dossier, to pharmaceutical companies with their own OTC brands, both nationally and for the whole of Europe.