ABSTRACT
Title
Herbal medicines: food or drugs ?
Authors
G. Calapai
Dept. of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Messina.
Member Herbal Medicinal Products Committee (HMPC) of the European Medicines Agency (EMA), London.
Dept. of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Messina.
Member Herbal Medicinal Products Committee (HMPC) of the European Medicines Agency (EMA), London.
Abstract
A lot of herbal medicines (whole plants, parts of plants, seaweeds, mushrooms) and vegetable preparations (extracts, oils, tinctures) are marketed in European countries both as medicinal products and as food supplements. In the last years the European Union delivered new laws to regulate their use. Medicinal use of herbals is ruled with the European Directive 24/EC/2004; use as food is regulated by the Regulation N° 1924/2006 on nutrition and health claims on food [1]. Even though these rules are useful to clarify issues such as medical uses and transparency of information, some raising points need to be discussed. How the differentiation on scientific basis between medicinal and health promoting uses herbal medicines can be operated ? How a clear differentiation between food and medicines can proposed to the consumers ? How is possible to keep marketed products containing the same ingredients in medicinal products as well as in food ?
Safety evaluation is another crucial point, because food intake is generally not time limited as happens for medicinals which use generally includes contraindications and limit in duration of use [2, 3]. Today, the main differences are regulatory and in particular concerning documentation needed for the market authorization. Medicines are products for the care of diseases and market authorization is delivered after evaluation of pharmacological and toxicological data. Food supplements are intended for nutrition or health keeping effects and they are not subjected to pre-marketing procedures for the authorization. Market authorization requires a registration, even though, the more recent legislation includes the possibility to use health or nutritional indications (claims) for food.
According to the new rules, indications for use should be different between herbal medicines and food supplements without any overlapping indications. In particular, medicinal products are indicated for prevention or care of diseases or to modify body functions. Food supplements are indicated to supply body functions through the activity of substances with health-keeping or health-promoting properties. However, the following questions raise: when food becomes a medicine ? What is the border between the two categories ?
Elucidating these questions is a complicated thing. It needs to take in account that biological effects of vegetable substances can be different depending on dose changing, sex, age, route of administration, individual susceptibility, physiological and pathological conditions [4]. For this reason, clarification of the role of herbal medicines as drug or food requires a better knowledge of their biological effects when used for different indications according to nutritional, therapeutic, health-keeping or health-promoting properties.
[1] Coppens P, et al. (2006) European Botanical Forum. Use of botanicals in food supplements. Regulatoryscope, scientific risk assessment and claim substantiation. Ann Nutr Metab.50, 538-554.
[2] Calapai G. (2008) European legislation on herbal medicines: a look into the future. Drug Saf. 31, 428-431.
[3] Rietjens IM, et al. (2008) Risk assessment of botanicals andbotanical preparations intended for use in food and food supplements: emerging issues. Toxicol Lett.180, 131-136.
[4] Bast A., et al. (2002) Botanical health products, positioning and requirements for effective and safe use. Environmental Toxicology and Pharmacology 12, 195-211.
Safety evaluation is another crucial point, because food intake is generally not time limited as happens for medicinals which use generally includes contraindications and limit in duration of use [2, 3]. Today, the main differences are regulatory and in particular concerning documentation needed for the market authorization. Medicines are products for the care of diseases and market authorization is delivered after evaluation of pharmacological and toxicological data. Food supplements are intended for nutrition or health keeping effects and they are not subjected to pre-marketing procedures for the authorization. Market authorization requires a registration, even though, the more recent legislation includes the possibility to use health or nutritional indications (claims) for food.
According to the new rules, indications for use should be different between herbal medicines and food supplements without any overlapping indications. In particular, medicinal products are indicated for prevention or care of diseases or to modify body functions. Food supplements are indicated to supply body functions through the activity of substances with health-keeping or health-promoting properties. However, the following questions raise: when food becomes a medicine ? What is the border between the two categories ?
Elucidating these questions is a complicated thing. It needs to take in account that biological effects of vegetable substances can be different depending on dose changing, sex, age, route of administration, individual susceptibility, physiological and pathological conditions [4]. For this reason, clarification of the role of herbal medicines as drug or food requires a better knowledge of their biological effects when used for different indications according to nutritional, therapeutic, health-keeping or health-promoting properties.
[1] Coppens P, et al. (2006) European Botanical Forum. Use of botanicals in food supplements. Regulatoryscope, scientific risk assessment and claim substantiation. Ann Nutr Metab.50, 538-554.
[2] Calapai G. (2008) European legislation on herbal medicines: a look into the future. Drug Saf. 31, 428-431.
[3] Rietjens IM, et al. (2008) Risk assessment of botanicals andbotanical preparations intended for use in food and food supplements: emerging issues. Toxicol Lett.180, 131-136.
[4] Bast A., et al. (2002) Botanical health products, positioning and requirements for effective and safe use. Environmental Toxicology and Pharmacology 12, 195-211.