Health & Nutrition
Regulation of Natural Health Products (NHP) in Canada
Regulation of Natural Health Products (NHP) in the United States
Regulation of Natural Health Products (NHP) in Europe
Regulation of Natural Health Products (NHP) in Canada
In Canada, the regulation of natural health products is governed by the Natural Health Products Directorate (NHPD) branch of Health Canada and food regulations are regulated through the Canadian Food Inspection Agency (CFIA).
To start finding your way through Canada’s regulatory framework, there are a couple of questions you must first ask which will define the particular regulatory authority governing your product:
Is my product a food or food ingredient, a feed, or a natural health product?
- Ingredients, as set out in Schedule 1 of the NHP Regulations, include plant or plant material, bacteria, fungi, extracts and isolates (provided there is no change in the molecular structure from the original source), vitamins, amino acids, essential fatty acids, synthetic duplicate versions of the previous substances, probiotics and minerals.
- Claims for NHPs include products manufactured, sold or represented for use in: the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state or symptoms in humans; restoring or correcting organic functions in humans; or modifying organic functions in humans in a manner that maintains or promotes health.
If my product is a food, food ingredient or feed, is my product novel?
Novelty as a Regulatory Trigger
Canada is the only country which regulates on a basis of ‘novelty’, as opposed to the method of production. Novelty, loosely referred to as ‘something unknown’, has different connotations depending on the product and novel plants or plant materials are regulated as Plants with Novel Traits (PNTs)
Natural Health Products
Natural health products are regulated under the Food and Drugs Act and are regulated under the Natural Health Products Regulations. The framework for regulating NHPs addresses:
- Product licensing
- Guidance document
- Compendium of monographs
- Evidence of quality of finished NHPs
- Evidence of safety and efficacy of finished NHPs
- Standards of evidence for evaluation of safety and
claims of natural health products: workbook for consultation - Process map
- List of licensed NHPs
- Site licensing
- Good manufacturing practices (GMPs)
- Adverse reaction reporting
- Adverse reaction guidance document
- MedEffect: a website dedicated to AR with warnings, guidance documents, reporting documents and a database of reactions
- Clinical trials
- The definition of a clinical trial is an investigation of a NHP on a human subject. A guidance document is available, but the NHPD’s Standards of Efficacy framework allows for a range of evidence to be submitted.
- Labeling and packaging
- Advertising
- Overview of health product advertising
- Policies and guidance documents
- Advertising preclearance
- Consumer advertising guidelines for NHPs
- Regulatory requirements for advertising drugs and health products
- Guidelines for cosmetic advertising and labeling claims
- Advertising Standards Canada
- Compliance
Health Claims
NHPs: Claims for NHPs are implied in the definition of a NHP
Functional foods: Functional foods (FF), as defined by Health Canada (2005) are ‘foods that are similar in appearance to, or may be a conventional food that is consumed as part of a usual diet, with demonstrated physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions’.
Currently, Canada has no regulatory policy for FFs. Products must be approved as NHPs or food/food ingrdients.
Foods: Claims for foods may be in the form of nutrition or health claims. Currently 5 health claims are allowed for foods. An interim guidance document for preparing submission for foods with health claims is available.
Useful Canadian Regulatory Articles/Websites
- Regulation of Foods with Health Claims: a Proposal
- Canada’s Regulations for Novelty in Plants, Feeds and Food: Final Report June, 2007
- American Journal of Clinical Nutrition - Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid
- Food Processors of Canada
- Health Canada - Health Products and Food Branch - Publications
- The Future of Natural Health Products in Canada
Useful Global Regulatory Articles/Websites
- Intellectual Property Management in Health and Agricultural Innovation Sept. 2007-( this document is read only.)
- Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology: Case Studies
- Agriculture and Agri-Food Canada Regulatory Information
- A Comparative Analysis of the Regulatory Framework Affecting Functional Food and Functional Food Ingredient Development and Commercialization in Canada, the United States (US), the European Union (EU), Japan and Australia/New Zealand
- Journal of Food, Agriculture and Environment – Nutraceuticals and functional foods: Current international regulatory status
- The global regulatory environment for nutraceuticals
Regulation of Natural Health Products (NHP) in the United States
Dietary Supplements
Natural health products in the US are generally regulated as dietary supplements and fall under the Food and Drug Administration (FDA) Dietary Supplement Health and Education Act of 1994 (DSHEA).
Dietary Supplement Definition A dietary supplement is a product (other than tobacco) intended to supplement the diet and contains one or more of the following dietary ingredients: a vitamin, mineral, herb or other botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients, and is in the form of a pill, capsule, tablet, or liquid.
- Dietary Supplements Overview
- Guidance for industry: substantiation for dietary supplement claims made under Section 403(r)(6) of the Federal Food, Drug and Cosmetic Act
- Dietary Supplements: Industry information and regulations
- Fact Sheet on FDA's Strategy for Dietary Supplements
- Dietary Supplements Publications
Food and Food Ingredients
Food and food additives are regulated in the US through the Food, Drug and Cosmetics Act Functional foods, although they have no formal regulations, generally fall under the food ingredients regulations of the FDA Centre for Food Safety and Applied Nutrition
New food ingredients require pre-market approval by the FDA unless Generally Recognized as Safe (GRAS) for its intended use.
- Food Labeling and Nutrition: Information for industry
- Food and Cosmetics guidance documents
- EAFUS: A Food Additive Database
- Frequently asked questions about GRAS
- Eligibility for classification as generally GRAS
- Summary of all GRAS notices
- Select Committee on GRAS Substances (SCOGS) Database Overview
Useful American Regulatory Articles/Websites
Regulation of Natural Health Products (NHP) in Europe
New European Union regulations on nutrition and health claims are expected to come into effect January 2007. Companies have 12 months to submit health claim petitions and then from these submissions and the existing claims, the European Food Safety Authority (EFSA) will produce a central list of approved claims. This must be accomplished by January 1, 2010.
- European Food Safety Authority
- Regulation of the EU Parliament on nutrition and health claims made on foods
- Position of the European Parliament adopted at second reading on 16 May 2006 with a view to the adoption of Regulation (EC) No .../ 2006 of the European Parliament and of the Council on nutrition and health claims made on foods
- Table of allowable food claims
Useful European Regulatory Articles/Websites
- Food Safety: from the farm to the fork
- How does the new European health regulation proposal affect conveying the nutrition and health of soy to the consumer?
- The proposed regulation on health and nutrition claims: myths and misunderstandings