Dietary Supplements

Safety, Efficacy and Quality

Katja Berginc, Samo Kreft

• Publisher: Woodhead Publishing
• Year: 2014
• Print ISBN: 9781782420767
• eBook ISBN: 9781782420811
• Topic: Technology & Engineering
• Subtopic: Nutrition, Dietics & Bariatrics
• Index: Technology & Engineering

Dietary supplements made from foods, herbs and their constituents are a rapidly growing market sector. Consumers often view food supplements as 'natural' and therefore safe; however, supplements are regulated as foods rather than as pharmaceuticals and so are not as closely monitored as may be necessary. With the commercial market in these products growing, this book provides essential research into their safety, efficacy and potential risk of interaction with pharmaceuticals. Following an introductory chapter, part one covers the chemical composition, manufacture and regulation of dietary supplements. Part two looks at the effectiveness of different types of dietary supplement and methods of evaluation. Finally, part three focuses on supplement safety. - Reviews the design, production and regulation of dietary supplements. - Analyses the potential for pharmacokinetic and pharmacodynamics interactions between dietary supplements and pharmaceuticals. - Offers reviews of important clinical studies on the efficacy of dietary supplements for range of conditions.

Part One

General issues

1

Dietary supplement labelling and health claims

I. Pravst Nutrition Institute, Ljubljana, Slovenia

Abstract

In the European Union (EU), food supplements are regulated as food, and covered by general food legislation and EU Directive 2002/46/EC on food supplements. The labelling of food supplements is regulated by both specific and broader food regulations. Harmonised health claims regulation was accepted in the EU in 2006, and all health claims now require specific authorisation by the European Commission through the comitology procedure, following the scientific assessment and verification of the claim by the European Food Safety Authority (EFSA). In this article, the labelling of food supplements in the EU and the possibility of making health claims is discussed, together with a description of the conditions for the scientific substantiation and authorisation of novel health claims.

Keywords

Dietary supplements

Food supplements

Labelling

Nutrition claim

Health claim

Substantiation

Regulation

1.1 Introduction: the regulatory situation in the European Union (EU)

In the EU, food supplements are regulated as food and covered by general food and specific food supplements legislation. To ensure the protection of consumers and facilitate their choices, products must be safe and appropriately labelled. The quality and safety of food supplements is the full responsibility of the producer, but can be controlled by national authorities.

While in different EU member states food supplements are regulated by local regulations, these regulations should be in harmony with EU Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the member states relating to food supplements (EC, 2002). Food supplements are considered as foodstuffs whose purpose is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop-dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

However, the labelling of food supplements also needs to be in line with general food labelling. EU member states harmonised their local regulations in the year 2000 according to Directive 2000/13/EC on the approximation of the laws of the member states relating to the labelling, presentation and advertising of foodstuffs (EC, 2000). In 2011, a harmonised EU Regulation (EU) No 1169/2011 on the provision of food information to consumers was adopted (EC, 2011b) and from the end of 2014 it will be in use instead of Directive 2000/13/EC.

Since food supplements are usually composed of vitamins, minerals or other food substances, a number of other regulations are also applicable. These include:

• Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods (EC, 2006b),

• Regulation (EC) No 258/97 concerning novel foods and novel food ingredients (EC, 1997).

It should be noted that only authorised forms of vitamins and minerals can be used in food supplements in the EU, and they are listed in Annex II of EU Directive 2002/46/EC (EC, 2002). However, the addition of other substances is regulated in Regulation (EC) No 1925/2006 (EC, 2006b), which established the Community Register on the addition of vitamins and minerals and of certain other substances to foods (EC, 2013b). There are strict rules about the inclusion of new substances in this list of authorised substances, and all new applications are subject to evaluation of their safety by the European Food Safety Authority (EFSA). A number of substances are allowed outside the EU, but are not authorised for use within the EU, thereby limiting imports of such food supplements.

The use of nutrition and health claims on foods (including food supplements) was harmonised in the EU in 2006 by Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (NHCR) (EC, 2006a). Only authorised nutrition and health claims are allowed. All health claims require specific authorisation by the EC through the comitology procedure, following scientific assessment and verification of each claim by EFSA.

1.2 Labelling requirements

Because regulatory food supplements are considered as foods, their labelling should be in line with general food labelling requirements and specific requirements for food supplements.

1.2.1 General labelling requirements

In line with general food labelling provisions and definitions, the labelling of food supplements is compulsory as concerns both information on the identity, composition, properties or other characteristics, and information on the protection of consumers' health and the safe use of the food supplement. The list of compulsory information on labelling includes: (a) the name of the food supplement; (b) the list of ingredients; (c) any ingredient or processing aid causing allergies or intolerances that is used in the manufacture or preparation of a product and is still present in the finished product, even if in an altered form; (d) the quantity of certain ingredients or categories of ingredients; (e) the net quantity of the product; (f) the date of minimum durability or the “use by” date; (g) any special storage conditions and/or conditions of use; (h) the name or business name and address of the food business operator; and (i) instructions for use.

It should be noted that the list of ingredients must include all of the food's ingredients, in descending order of weight, as recorded at the time of their use in the manufacture of the food. Ingredients must be designated by their specific name. All additives must be labelled with their function (i.e. sweetener, colour, carrier, etc.) according to the list of functional classes of food additives (EC, 2008, 2011b). All ingredients present in the form of engineered nanomaterials must be clearly indicated on the list of ingredients. The names of such ingredients must be followed by the word “nano” in brackets. All substances which can cau...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright page
• List of contributors
• Woodhead Publishing Series in Food Science, Technology and Nutrition
• Introduction
• Part One: General issues
• Part Two: Drug–supplement interactions
• Part Three: Vitamins, minerals and probiotics as dietary supplements
• Index