Healthy Skepticism Library item: 8739
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
 
Publication type: Journal Article
Coppens P, Delmulle L, Gulati O, Richardson D, Ruthsatz M, Sievers H, Sidani S; European Botanical Forum.
Use of botanicals in food supplements. Regulatory scope, scientific risk assessment and claim substantiation. 2005.
Ann Nutr Metab. 2006 Dec 21; 50:(6):538-54
http://content.karger.com/produktedb/produkte.asp?typ=fulltext&file=000098146
Abstract:
BACKGROUND/AIMS: In the European Union, an elaborate legal framework regulates botanical products both under food and medicinal law. The decision as to which legal framework applies to an individual product may differ between the Member States. In the case of botanical food supplements, all food law provisions apply to their manufacturing, composition and marketing, including the new claims legislation.
METHODS: Elements from EU and national law, scientific and other publications are brought together to investigate how to clarify the differentiation between the use of botanicals for medicinal and health-promoting purposes on a scientific basis.
RESULTS: Guidance on the safety assessment and quality evaluation of botanicals is proposed in light of the different approaches described in the scientific literature with particular attention to the concept of long-term use as an integral part of safety evaluation. Guidance on claims substantiation is also included, taking into consideration the proposed legislation, the concept of long-term experience and grading of evidence.
CONCLUSIONS: A model for safety and efficacy assessment of botanical food supplements in the EU is proposed, and should be taken into consideration in the development of legislation and scientific research on botanicals. Copyright 2006 S. Karger AG, Basel.
Keywords:
Botanicals, safety assessment
Herbal medicinal products, legislation
Food supplements, health claims
Risk assessment, herbal medicine
Functional foods, herbal
Publication Types:
Consensus Development Conference
Research Support, Non-U.S. Gov't
MeSH Terms:
Animals
Biomedical Enhancement/standards
Consumer Product Safety/legislation & jurisprudence*
Consumer Product Safety/standards
Decision Trees
Diet Therapy/standards
Dietary Supplements/adverse effects
Dietary Supplements/standards*
Dose-Response Relationship, Drug
Drug Labeling
European Union
Evaluation Studies
Evidence-Based Medicine/standards
Food Labeling/legislation & jurisprudence
Health Promotion
Humans
Legislation, Food
Phytotherapy/standards
Plant Preparations/adverse effects
Plant Preparations/isolation & purification
Plant Preparations/standards*
Plant Preparations/therapeutic use
Plants, Toxic/adverse effects
Risk Assessment
Species Specificity
Substances:
Plant Preparations