In Canada, the Food and Drugs Act sets the legal requirements for the production and sale of natural health products, which include functional foods and nutraceuticals. Under the Food and Drugs Act, all products intended for human consumption are regulated as either a "food" or a "drug." A drug is broadly defined by the Act to include substances that will restore, correct or modify a bodily function. The definition of a drug also includes any substance that is sold or represented for sale as a treatment, prevention or cure of a disease, disorder or abnormal physical state. In practical terms, this means that if a product has one of these purposes or the manufacturer makes explicit or implicit claims that a product will achieve one of these purposes, it will be treated by the Canadian regulatory authorities as a drug product. Even in the absence of claims, vitamin and mineral supplements are considered drugs in Canada.
Not surprisingly, Canadians have voiced discontent with this outdated approach to the regulation of natural health products. The growing tendency of Canadian consumers to take more responsibility for their own health has led to increased awareness and demand for natural health products. Increased consumer awareness in conjunction with a number of actions taken by the Canadian federal government over the last decade has generated considerable debate over the regulation of these types of products. These actions included, for example, Schedule 705 with its proposed list for restriction of the use of some herbs and botanicals as foods; the enactment of the Controlled Drugs and Substances Act; working with the U.N. Codex Alimentarius Commission Committee; and cost recovery regulations put forward by Health Canada.
October 4, 1997:
Natural Product Public Hearings
These are some of the factors that led to the announcement on October 4, 1997, by the Federal Minister of Health, Allan Rock, of his intention to request that the House of Commons Parliamentary Standing Committee on Health hold public hearings on the legislation and regulation of natural health products in Canada. The Standing Committee is comprised of elected Members of Parliament from across Canada. From February 1998 to May 1998, the Standing Committee received testimony from a broad range of Canadian consumer, practitioner, industry and regulatory representatives, as well as international participants from Australia, Germany, the U.K. and the U.S.
During the public hearings, the Standing Committee was presented with the results of a CTV/Angus Reid Group Poll taken in August 1997, which indicated that 67% of Canadians feel that the federal government should regulate natural health products to ensure product safety and quality1. The results of a survey by the Canada Health Monitor (Survey 16, June-July 1997) were also presented to the Standing Committee. This survey revealed that 56% of Canadians reported taking one or more natural health products in the past six months. Among this 56%, 47% had taken vitamins, 22% mineral supplements, 20% herbal remedies and teas, 8% homeopathic products, 5% nutraceuticals and 4% some other products2. The Standing Committee noted that it was difficult to estimate the total Canadian market size for natural health products, although it received testimony that suggested that the gross income of the natural health product industry in Canada ranged between Cdn.$1.5-2 billion in 1997, with annual growth of 10-15%3.
The former Minister of Health, David Dingwall, had established an Advisory Panel on Natural Health Products in May of 1997. The Advisory Panel's mandate at that time was to provide Health Canada with advice and guidance on both the regulation of, and policies on, natural health products. The current Minister of Health, Mr. Rock, requested that the Advisory Panel appear before the Standing Committee to provide its recommendation for the regulation of natural health products.
May 13, 1998:
Natural Products Advisory Panel Comments
The following are a few of the highlights of the presentation of Dr. Frank Chandler, Chair of the Advisory Panel, in his presentation to the Standing Committee on May 13, 1998:
• "...natural health products are really neither food nor pharmaceuticals....these natural health products do indeed fall somewhere in between, both in function and in control. The current regulatory framework, we believe, needs substantial revision to meet the unique aspects and properties of the natural health products."
• "...we feel with this group of products, the legislation that will ensue needs to be more permissive, rather than predictive or prescriptive, that interventions need to be on the minimalist side and need to be very directly correlated with the relative risk of any of the products.
• "We'd like to see some leniency...for bringing products to market where a reasonable amount of evidence in...traditional practice exists."
• "We believe representatives of industry, practitioners and consumers must be involved in drafting new regulations."4
November 2, 1998:
Nutraceuticals/Functional Foods Policy Paper
On November 2, 1998, the Therapeutic Products Programme and the Food Directorate of Health Canada made available to the Standing Committee a Policy Paper entitled: "Nutraceuticals/Functional Foods and Health Claims on Foods." The stated purpose for this project was to analyze the Canadian situation and review a range of policy alternatives to address issues raised by stakeholders and recommend a conceptual framework for the regulation of health claims on nutraceuticals/functional foods.
In the section entitled "Final Policy Decision," this document indicates that "Structure/function and risk reduction claims for foods should be permitted, while all other products claiming to cure, treat, mitigate or prevent illness should continue to be regulated as drugs. This policy should allow structure/function claims and risk reduction claims for food and food components; appropriate standards for evidence and composition would be required...For implementation the model would require an exemption by regulation for products with structure/function and risk reduction claims. Under this regime, the requirements for supporting evidence and other controls on food products with claims would be likely to vary, depending on the risk-benefit profile of the product submitted for review..."
November 4, 1998:
Natural Health Products Vision Statement
On November 4, 1998, The House of Commons Standing Committee formally presented in the House of Commons its report entitled: "Natural Health Products: A New Vision."
The Standing Committee's recommendations reflect its effort to strike a balance between safety and access to natural health products. Some of the more noteworthy recommendations are:
• A call for a new regulatory structure that would operate in parallel to the current Foods Directorate and Drugs Directorate (Therapeutic Products) within the Health Protection Branch of Health Canada to regulate natural health products.
• Natural health products be allowed to make health claims, including structure-function claims, risk-reduction claims and treatment claims.
• An Expert Advisory Committee be established immediately to assist Health Canada in the general and specific tasks necessary to design a new natural health products regulatory environment.
• Health Canada, in collaboration with the natural health products industry, establish appropriate Good Manufacturing Practice Guidelines reflective of the different nature of natural health products.
• A product licensing system based on monographs be used when they are available. Such a system should rely on a pre-market approval process and the regulator should have a short period of time (for example, 30 days) to review the application.
• Sufficient resources be provided for enforcement activities.
• Manufacturers, packagers, importers and distributors of natural health products, whether located in Canada or abroad, be obliged to hold valid establishment licenses5.
The Reform Party of Canada-the official opposition (as represented by Grant Hill, MP; Reed Elley, MP and Maurice Vellacott, MP)-did not support the report and submitted a Minority Report. The Reform party felt that although the report contained a number of positive recommendations that deserved attention, in the final analysis, the "Committee's overall report recommends a continuation of the existing situation of a paternal federal government that must protect Canadians from the unknown evils of natural health products."
Reform asserts that natural health products should be under the preview of Health Canada's Food Directorate to "ensure that these substances are viewed with the culture most familiar to them and thereby never again fall victim to the intimidating practices and procedures of the Drugs Directorate (TPP)."
Reform also disagreed with the Committee's recommendation for more resources for natural health products regulatory enforcement. The Minority Report concludes: "While Reform is optimistic the recommendations contained in the Final Report move in the right direction, Reform still believes Canadians deserve, and will continue to demand, much more freedom of choice over natural health products. Reform believes an informed Canadian consumer will always be a better judge of what is best for them and their loved ones than some distant bureaucrat in Ottawa."
The New Democratic Party (NDP) represented by Judy Waslycia-Leis, MP (Winnipeg North Centre) also submitted a Minority Report. This report suggests that the Standing Committee's report falls short of Canadians' expectations and leaves many unanswered questions. The NDP report criticizes the fact that many important decisions have been left to an Expert Advisory Committee in conjunction with Health Canada, including such basic matters as the definition of natural health products, the criteria by which products will be judged and whether an in-house research laboratory will be reestablished. The NDP report also notes that "time and time again, participants expressed lack of confidence in the ability of [Health Protection Branch of Health Canada] to regulate in a fair and balanced way." The NDP report concluded with four recommendations:
1. public investigation into the Health Protection Branch;
2. immediate reestablishment of a natural products research laboratory;
3. ensure that what's on the label is what's in the bottle; and
4. information, education and recognition.
The Standing Committee has requested that the government present a comprehensive response to its report. Pursuant to Standing Order 109, that response must be provided within 150 days of the presentation of the report. In the meantime, Canadian consumers and members of the natural health products industry anxiously await the federal government's response to the Standing Committee's report. NW
References:
1Report of the Standing Committee on Health, Natural Health Products: A New Vision, Joseph Volpe. M.P., Chair, November 1998, pp 2-3.
2Ibid, p. 3.
3Ibid, p. 3.
4Dr. Frank Chandler, Chair of Advisory Panel on Herbal Health Products, Presentation to the Standing Committee on Health, House of Commons, Ottawa, May 13, 1998.
5This report is available at the Parliamentary website at http://www.parl.gc.ca.
About the author:
Wendy Hulton is a Partner with the law firm Miller Thomson, located in Toronto, Ontario. Ms Hulton acts for international clients on matters related to the Food and Drugs Act and Competition Act. On behalf of clients, she negotiates with government regulators on a broad range of administrative and regulatory issues. Ms Hulton can be reached at Miller Thomson, 20 Queen Street W. Ste 2500, Toronto, Ontario, Canada; 416-595-8608; Fax: 416-595-8695; E-mail: whulton@millerthomson.ca
