In March of 1999 the Canadian Minister of Health responded to a study tabled by the Standing Committee on Health by announcing the creation of a new Office of Natural Health Products (ONHP). In May he announced the creation of a Transition Team (TT) to assist in setting up this new office. This Transition Team has issued its first progress report.
Mission: The Mission of the ONHP is to ensure that all Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.
Vision: This new Office will be recognized as the national authority for the management of natural health products used in Canada, respected worldwide as a leader in natural health product regulation and a leading national and international partner in the management of natural health products and will create and maintain an innovative regulatory environment based on a wellness model that will become a global standard in natural health products regulation.
The Transition Team has established linkages with other key Health Canada personnel responsible for food safety and nutrition policies, Health Promotion programs and Health Protection Branch Legislative Renewal. These discussions have focused on incorporating wellness promotion models in all new legislation, policies and program initiatives.
They have set the criteria and published for the hiring of an executive director for the new office. As we went to press, the executive director had reportedly been named, although the government would not yet confirm the appointment. An official announcement is expected early in 2000, but industry rumors indicate that the man is a naturopathic physician.
The team has also drafted a definition of natural health products and a system for classifying products for internal review although they have not, as yet, published these definitions.
They have recommended to the Canadian Codex contact point that since natural health products are neither foods nor drugs they should be exempt of the considerations of the Codex Alimentarius.
The team has also drafted a model for the structure of the new office as well as the role and function of the Expert Advisory Committee that will assist the executive director in the development of policies and regulations for NHP's.
Some Key Recommendations Of Transition Team
1. The definition of natural health products (NHP's) will include an algorithm to further differentiate NHP's from foods and drugs classification, a relative risk matrix to assist in identifying lower and higher risk products on the basis of safety and claims and lists or schedules of products where required.
2. With regard to bulk herbs, the team proposed that they remain in the food category as long as no claims are made and there are no contraindications.
3. Concerning product licensing, the team is proposing a balance between pre and post market notification requirements that will rely on a quality assurance approach and standards that can be used to facilitate market entry. The objective is to have the ONHP able to focus on new products and non-standard claims. (It is generally agreed that all NHP's will be registered and the manufacturers, importers and distributors of these products will be licensed. The current DIN (Drug Identification Number) system will be replaced with some type of product identification number. This number will be attached to a Quality Assurance program.)
4. The Team recommended that Schedule 'A' and Section 3 (1 & 2) of the Food and Drug Act be revoked or amended. These provisions were originally designed to restrict claims and advertising with respect to serious diseases but they limit efforts devoted to disease prevention and health maintenance.
Once the ONHP's executive director is officially hired and the Expert Advisory Committee is in place, which is expected by early 2000, the ONHP is projected to be up and operating by the middle of 2000. In the meantime the current regulations remain and the Therapeutic Products Directorate maintains a basic "hands off" policy with regard to NHP's except where flagrant violations or threats to public safety exist.
In The Meantime...Over At The Food Directorate
The Food Directorate is attempting to be seen to be moving as quickly as possible in addressing the issue of health claims for foods. At the present time most botanical and herbal products are regulated as foods with no health benefit claims permitted. The problem here is that Canada has apparently decided that NHP's are not foods and therefore it is not clear exactly what products the Foods Directorate intends to address.
Excerpts from Fall 1998 Final Policy Paper on Nutraceuticals/Functional Foods and Health Claims on Foods:
The preferred option...that structure/function and risk reduction claims for food products be permitted, these types of claims may be generic (that can be applied to any food that meets the criteria for the claim) or; product-specific claims that cannot be generalized to other similar products unless acceptable supporting evidence is provided. The policy also recognizes the need for appropriate standards of evidence for claims.
Food Directorate Taking A Three-Part Approach
I. to adopt U.S. generic health claims in the Canadian context-Health Canada will consider those existing U.S. generic health claims that were authorized by the Food and Drug Administration under the standards of evidence in the Nutrition Labeling and Education Act; are consistent with current science; and that stakeholders agree are appropriate in the Canadian context. This step includes updating the scientific evidence for these claims and amending the Food and Drug Regulations to permit their use in Canada.
II. to develop standards of evidence and a guidance document on data requirements for supporting the validity of new health claims for foods-Health claims must be valid and supported by acceptable scientific evidence. An Expert Advisory Panel has been established to advise Health Canada on developing standards of evidence (that is, the type, quality and quantity of evidence) that would be appropriate for supporting new health claims. Other criteria, including product safety and quality assurance, will also be considered to ensure that products making health claims meet necessary requirements.
III. to develop an appropriate regulatory framework to allow new health claims for foods-Developing new regulations and/or amendments to existing regulations, where required, will be initiated to enable the use of new health claims for foods. The establishment of a regulatory framework for new health claims for foods will take into account developments in related legislation and regulations.
Therefore...as the lead agency in implementing the health claims policy for foods, the Food Directorate will coordinate with the Therapeutic Products Programme, Office of Natural Health Products and the Canadian Food Inspection Agency regarding implementation issues for health claims for foods, nutraceuticals and for natural health products. Health claims for nutraceuticals and for natural health products are outside the current scope of the implementation plan for foods.
Currently in Canada there is very little enforcement. Many companies are marketing herbal products with a wide range of health benefits and the Therapeutic Products Directorate (TTD), which has been clearly eliminated from the process of regulating the products, has essentially turned a blind eye to the situation.
The TTD has, as a result of the political process of the past two years, been removed from the loop and even though the regulations and laws have not changed, enforcement is almost non-existent unless trade complaints are made by other companies. Consequently on the shelves are all types of presumably illegal claims for supplements; very few botanical supplements appear to be being tested for identity and much confusion seems to exist.