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1 From the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg, Canada
2 Presented at the workshop "The Role of Conjugated Linoleic Acid in Human Health," held in Winnipeg, Canada, March 13-15, 2003. 3 Address reprint requests KC Fitzpatrick, Richardson Centre for Functional Foods & Nutraceuticals, Room 256 Agriculture Building, University of Manitoba, Winnipeg, MB, Canada R3T 2N2. E-mail: kelley_fitzpatrick{at}umanitoba.ca.
ABSTRACT
The Canadian Food and Drugs Act and Regulations, through its definitions of food and drug, currently restricts health-related claims for foods, food ingredients, and natural health products (NHPs). Over the past few decades, scientific research has led to a large body of information that demonstrates the benefits for health of many food and NHP ingredients. Health Canada recognized the constraints of the current regulatory environment and started to develop regulations related to the allowance of health claims for functional foods and NHPs, including those foods and NHPs that would contain conjugated linoleic acid isomers. Health Canada has 3 initiatives under way in the area of health claims for foods: 1) to adopt the generic health claims of the United States within a Canadian context, 2) to develop scientific standards of evidence and a guidance document for supporting the validity of product-specific claims, and 3) to develop an overall regulatory framework for functional foods. In 2000, Health Canada announced approval for the use of 5 generic diet-related health claims: sodium and hypertension, calcium and osteoporosis, saturated and trans fat and cholesterol and coronary artery disease, fruits and vegetables and cancer, and sugar alcohols and dental caries. Under a separate initiative, Natural Health Products Regulations were published in the Canada Gazette Part II on June 18, 2003. The NHP Regulations came into force on January 1, 2004, with a transition period ranging from 2 y (for site licensing) to 6 y (for product licensing, for products already issued a drug identification number).
Key Words: Functional foods • natural health products • conjugated linoleic acid • Health Canada • Foods and Drug Act and Regulations
INTRODUCTION
The functional foods and natural health products (NHPs) industries have garnered a great deal of attention and enthusiasm on the part of governments, the agri-food sector, and the research community in Canada. In 1998, Health Canada proposed the definition of a functional food to be similar in appearance to a conventional food, to be consumed as part of the usual diet, to demonstrate physiologic benefits, and/or to reduce the risk of chronic disease beyond basic nutritional functions (1). NHPs in Canada include homeopathic preparations, substances used in traditional medicine, a mineral or trace element, a vitamin, an amino acid, an essential fatty acid, or other botanical-, animal-, or microorganism-derived substance (2). In 2001, Canadians purchased approximately US$4.2 billion worth of functional food products and NHPs in comparison to US$3.9 billion in 2000 (3). This amount translates into nearly Can$140 per capita spending, a 130% increase in only 4 y.
According to a recent study conducted for the Canadian government, it is estimated that up to Can$1 billion of farm production value is devoted to supplying ingredients for functional foods and NHPs (Scott Wolfe Management, unpublished observation, March 2002). This estimate does not include the marine industry, which presents a significant opportunity for production of n–3 (omega-3) fatty acids, glucosamine, and other products. Another report noted that lifestyle-related chronic disorders are a major component of increasing health care expenditures in Canada (B Holub, unpublished observation, June 2002). The proportion of disease onset attributable to diet was estimated in that study to be 40–50% for cardiovascular disorders and diabetes, 35–50% for cancers, and 20% for osteoporosis. In that report, the researcher presents strong arguments to support the role of functional foods and NHPs in reducing the prevalence of chronic disease in Canada and in providing impressive savings in health care costs without significant overall dietary changes.
REGULATORY CHALLENGE IN CANADA
The Canadian Food and Drugs Act and Regulations was passed into law in 1953. The definition of food under the Act and Regulations includes "... any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever." Drugs are defined as "... any substance or mixture of substances manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, restoring, correcting or modifying organic function."
Through its definitions of food and drug, this legislation currently restricts health-related claims for foods, food ingredients, and NHPs. These products are considered as either foods or drugs, depending on the type and concentration of the active ingredient and whether claims are made. When regulated as a food, there are no provisions in the legislation to make claims of a health or therapeutic nature about the use of, or possible side effects of, the product. Thus, the consumer could be inadequately informed about the product. To protect consumers, Health Canada has banned or restricted the use of certain NHPs because the agency was unsure of the product’s safety as a food. For example, approved products in the United States, such as melatonin and single amino acids, are prohibited for sale in Canada at this time.
Any supplement or functional food that carries a health claim, or levels of ingredients not permitted for conventional foods, are currently regulated as drugs. This regulation requires a drug identification number (DIN) which is issued by the Therapeutic Products Directorate of the Health Protection Branch after it reviews a DIN application. The cost of a review will vary, but it is a significant investment for smaller companies. Companies have the choice of obtaining a DIN, manufacturing under drug good manufacturing practices, and marketing their NHPs or functional food products as a drug or simply selling it without claims. Note that the Tropicana company chose to market its product with a DIN and dosage information on the packaging as a "calcium and vitamin supplement," otherwise known as orange juice in the United States (4).
Further limiting the development of health claims in Canada are statements in Section 3 of the Act and Regulations which prohibit the sale or advertisement to the general public of any food, drug, cosmetic, or device that indicates a treatment, cure, or preventive role for diseases or disorders referred to in Schedule A which include heart disease, diabetes, cancer, hypertension, obesity, and arthritis. These diseases are the most common causes of morbidity and mortality in Canada and are diseases for which functional foods and NHPs have the potential to be most beneficial. Physiologic effects that relate to these conditions, such as lowering of serum cholesterol or glucose, are also considered under the umbrella of Schedule A and are precluded from appearing on labeling and in advertising. For health claims to appear in Canada, changes would have to be made to allow claims about Schedule A diseases or physiologic effects related to these diseases.
Health Canada has recognized that the regulatory framework does not support labeling and advertising of the potential health benefits of NHPs and functional foods to consumers. Beginning in 1996, Health Canada began a series of regulatory reviews for these product categories. Progress is being made in some areas.
FUNCTIONAL FOOD INITIATIVES
In the summer of 1996, the Food Directorate of the Health Protection Branch of Health Canada began deliberations, resulting in a policy options paper and in which the proposed definition for a nutraceutical was a product that has been isolated or purified from foods and is generally sold in medicinal forms not usually associated with food (1). Nutraceuticals would exhibit a physiologic benefit or provide protection against chronic disease. With the establishment of the Natural Health Products Directorate (NHPD) and a definition for NHP, the proposed category of nutraceuticals was included in the regulatory framework for NHP which is described later.
In the same proposal (1), a functional food was defined as being similar in appearance to a conventional food, consumed as part of the usual diet, able to demonstrate physiologic benefits, and/or able to reduce the risk of chronic disease beyond basic nutritional functions. In late 2001, Health Canada announced that a new regulatory definition for functional foods would not be required under the current Canadian Food and Drugs Act to permit health claims for foods (5). However, this term is used extensively in Canada to describe foods with health benefits beyond basic nutrition.
The Food Directorate also recommended allowing foods in Canada to carry claims of structure/function and claims of risk reduction and to continue to regulate therapeutic claims as drugs (1). The structure/function scenario would be similar to the regulatory framework for dietary supplements in the United States known as the Dietary Supplement Health and Education Act. Risk reduction claims are currently permitted for certain food and food constituents in the United States under the Nutrition Labeling and Education Act (NLEA). One key difference with the United States is that the proposed changes could allow product-specific claims, whereby a company sponsoring research and development on its product would be allowed an exclusive claim. Another food with the same active ingredient would not be able to make the claim unless supported by research.
Beginning in 1999, Health Canada undertook 3 initiatives in the area of health claims for foods.
1) Adoption of certain of the initial 10 diet-based disease risk reduction claims approved in the United States under the NLEA
At the time of the final policy paper (1), 10 generic health claims had been approved in the United States under the NLEA. Such claims apply to a food or a group of foods that have compositional characteristic(s) that contribute to a dietary pattern associated with reducing the risk of a disease or health condition. Once the claim is authorized, any food that meets the specified conditions for composition and labeling can carry the claim without further assessment. For each of these 10 claims, Health Canada asked key scientists in Canada to review the literature and submit reports addressing the legitimacy of the existing United States claims. In 2000, it was announced that 5 of the NLEA claims were considered valid in a Canadian context. These claims were sodium and hypertension, calcium and osteoporosis, saturated and trans fat and cholesterol and coronary artery disease, fruits and vegetables and cancer, and sugar alcohols and dental caries (6).
Each of these health claims required an individual amendment to the Foods and Drug Act. Details of the specific wording of the claims and criteria for the nutrient content of the food and other factors were published in January 2003 in Canada Gazette Part II as part of mandatory nutrition labeling regulations (7). By 2005, food labels in Canada will be required to provide more nutrition information such as core information on calories, fat, saturated fat, trans fat, cholesterol, sodium, carbohydrate, fiber, sugar, protein, vitamin A, vitamin C, calcium, and iron. For nutrition labeling purposes, isomers of conjugated linoleic acid (CLA), namely blends of the 2 most prominent CLA isomers (cis-9,trans-11-octadecadienoic acid and trans-10,cis-12-octadecadienoic acid) will not be considered as trans fat. Therefore, a label statement about the trans fat content of a food will not be required to include CLA isomers.
For the other 5 United States NLEA generic claims that were considered, Health Canada concluded that issues remained that did not allow their immediate approval. In the case of fat and cancer, there was considerable new evidence to question the role of dietary fat in cancer risk, such that Health Canada decided not to proceed with this claim. Decisions are still pending for the following 4 claims: folate and neural tube defects; fiber-containing grain products, fruits, and vegetables and cancer; fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary artery disease; soluble fiber and risk of coronary artery disease.
2) Develop standards of evidence and a guidance document on data requirements for supporting the validation of new health claims for foods
For other health claims, the Health Products and Foods Branch, using an internal working group, and in consultation with an expert advisory panel, developed a framework for the standards of scientific evidence required for health claims and a guidance document for industry. In June 2000, Health Canada published a Consultation Document titled "Standards of Evidence for Evaluating Foods with Health Claims: a Proposed Framework" (6).
The principles governing the proposed standards have 3 important elements. The first is product safety, which Health Canada interprets to be reasonable assurance of no adverse health effects. Second is claim validity as determined by demonstration of product efficacy and effectiveness on the basis of establishing an etiologic link between the desired effect and consumption of the food or bioactive substance at the recommended level of intake in the target population that will most likely benefit. Third is quality assurance, meaning that foods bearing health claims should be able to identify, measure, and maintain a consistent level of the bioactive substance to ensure efficacy without jeopardizing safety. Health Canada proposes that initially only claims with the potential for major public health benefit and for which there is sufficient acceptable scientific evidence should be given priority for evaluation.
According to Health Canada, the proposed standards are intended to reassure consumers that the products carrying the claims are safe and that the claims are valid. The standards would apply to all food or beverage products that bear direct or indirect claims about their health benefits. A direct health claim is clearly stated and straightforward, eg, "Calcium reduces the risk of osteoporosis." An example of an indirect or implicit health claim would be "Contains calcium," thereby relying on consumer awareness of the proposed benefits of the ingredient. The proposed standards do not include NHPs sold in dosage form.
3) Development of an appropriate regulatory framework to allow product-specific health claims for foods
In October 2001, Health Canada released a proposed approach to regulating product-specific health claims for foods (5). In the November 1998 policy options, Health Canada recognized that a claim concerning the effect of a food or its ingredient(s) or component(s) should not be generalized to other similar products unless acceptable supporting evidence was provided. This rationale is used for product-specific authorization, whereby each product with the intended claim is evaluated on its own merit. This concept recognizes that food matrices and processing conditions could have an effect on the physiologic property of foods. Therefore, an application containing product-specific evidence would be required for a similar claim on another product, unless generally accepted or specific nutritional or food science theory or knowledge would indicate otherwise.
It was proposed that, for a food that is manufactured, sold, or represented to have a direct, measurable effect on a body function or structure beyond normal growth and development or maintenance of good health (previously termed structure/function claims), detailed information be required and submitted to support such an effect before being advertised or offered for sale. The conditions that must be met before a food could be authorized to carry a claim or a representation conveying such an effect are outlined in that proposal.
An authorized claim would be identified by a claim identification number (CIN) that would be displayed in product labeling. Authorization would be granted on a product-by-product basis. However, given the current definitions of food and drug within the Food and Drugs Act and Regulations, as well as the restrictions imposed under Schedule A, new health claims on foods require individual amendments be made to the Act. This process is laborious and, as evidenced with the 5 generic claims recently approved, can take upward of 3 y to complete the regulatory process.
NATURAL HEALTH PRODUCTS INITIATIVES
The Office of Natural Health Products was formed in March 1999 to establish and implement a new regulatory framework for NHPs. In 2001, the Office became the NHPD, a parallel and equal department to Health Canada’s Food Directorate and Therapeutic Products Programme.
Proposed regulations for NHPs were published in Canada Gazette Part I, the first step toward amendments to the Foods and Drug Act and Regulations, on December 21, 2001 (2). Final NHP Regulations were published in the Canada Gazette Part II on June 18, 2003 (8). The NHP Regulations came into force on January 1, 2004, with a transition period ranging from 2 y (for site licensing) to 6 y (for product licensing, for products already issued a DIN). The main components of the regulations include NHP definitions, product licensing, adverse reactions reporting, site licensing, good manufacturing practices [requirements for product specifications (identity, purity, potency), premises, equipment, personnel, sanitations program, operations, quality assurance, stability, records, sterility, lot or batch samples, and recall reporting], standards of evidence for safety and health claims, and labeling and packaging.
Until publication of Canada Gazette Part II, the working definition for a nutraceutical in Canada has been "a product that has been isolated or purified from foods and generally sold in medicinal forms not usually associated with food. Nutraceuticals have been shown to exhibit a physiologic benefit or provide protection against chronic disease." Health Canada decided that the product category of nutraceuticals will be encompassed within NHP regulations (2). Under these proposals, NHP will include homeopathic preparations, substances used in traditional medicine, a mineral or trace element, a vitamin, an amino acid, an essential fatty acid, or other botanical-, animal-, or microorganism-derived substance.
Regarding health claims, NHP products will be allowed to be manufactured, sold, or represented for use in the diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans (ie, claims that are currently allowed in Canada only for drug products). Other health claims for NHP products include resorting or correcting organic functions in humans or maintaining or promoting health or otherwise modifying organic functions in humans. To allow drug type claims within the Foods and Drug Act and Regulations, these products will be regulated under a subsection of the Drug Regulations but will still be referred to as NHPs. The drug legislation is the vehicle to manage the process without requiring the opening of the Food and Drugs Act and Regulations or the time-consuming steps involved in establishing a new regulation for each new health claim.
All NHPs will be required to register with the NHPD, to obtain a distinct identifier number referred to as a PIN (product identification number) and to carry a label claim. The standards of evidence for safety and a health claim will correspond to the strength of the claim. For example, traditional references will be required for a product to carry self-care claims such as "Traditionally used to...." This reference is in contrast to a disease-related claim such as "Clinical trials show...." Such a claim will require the submission of data from a meta-analysis of randomized controlled trials or at least one well-designed (multicenter) randomized controlled trial.
One area of debate continues to be the definition of NHPs. Even though the proposal does not include conventional foods and is not intended to capture a product in a food medium, the rule is unclear as to whether foods bearing health claims or structure/function claims relating to a nutrient (eg, a beverage with the statement "contains calcium to help build strong bones") are outside the scope of the NHP regulation. For example, the proposed regulations state "Although ‘dosage form’ is not an express part of the definition, the NHPD recognizes that NHPs are usually sold in capsule, pill, tablet or liquid form. As well, certain other forms, such as gum or bars, have come to be considered acceptable dosage forms."
In comparing the Canadian NHP regulations to that of the Dietary Supplement Health and Education Act of 1994, there remains the possibility that NHPs available in Canada may be able to legally carry a much wider range of health claims than their US counterparts.
Despite that NHPs will be regulated as a subset of drugs, the concern remains that such products will be unable to make certain label claims, even if there is scientific evidence to justify them, because of the restrictions of Schedule A of the Food and Drugs Act. In February 2003, Health Canada notified the public and interested parties that a Working Group on Schedule A will be established pursuant to a Regulatory Review Program and in response to the House of Commons Standing Committee on Health’s report on NHPs (9). The Working Group’s mandate will be to make proposals with respect to the criteria that could be used for determining which diseases need to be included in Schedule A and on possible modifications to the Schedule.
Initiatives related to regulatory reform in Canada in the area of functional foods and NHPs are being watched with interest by other jurisdictions. For manufacturers of CLA as a food or NHP ingredient, such regulatory reform is critical to product introduction and success on the Canadian market.
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