CANADIAN APPROACH TO REGULATE FUNCTIONAL FOODS

17.5 CANADIAN APPROACH TO REGULATE FUNCTIONAL FOODS

In Canada, there are three components of regulatory framework that govern food products.

1. Regulations (laws) addressed in the Food and Drugs Act and Regulations

2. Guidelines

3. Premarket review requirements

Functional Food Carbohydrates

The Food and Drugs Act and Regulations (FDAR) are the Canadian laws dealing with foods, drugs, cosmetics, and medical devices. This law was introduced to ensure food safety and integrity. The act addresses the sale and manufacture of food in a safe manner and also deals with deceptive and dishonest labeling, marketing, and advertisement. There are several guidelines that were introduced by Agriculture and Agri-Food Canada and Health Canada to interpret the provisions of this act. Although these guidelines and proposals are not enforced by law, a number of them are relevant to functional foods, and they may become law in the near future. Furthermore, there are mandatory requirements as a part of FDAR for premarket review of specific categories of products, such as all drugs, food additives, infant formulae, and irra- diated foods. 31

The concept of functional foods is well known in Canada, which was one of the first countries to recognize the importance of this food category and acknowledge it

by issuing the official definition, which was discussed above. The definition does not have any legal meaning since there is no specific regulation dealing with functional foods. The current system exclusively offers manufacturers the option of licensing and selling functional foods as drugs if any health claims are attached. This is because the FDAR defines drugs 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,” while food is “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.” Section 3 (Part I) under the act specifically prohibits the sale or advertisement of any food to the general public represented as a treatment, preventive, or cure for any disease, disorder, or abnormal physical state as listed in Schedule A. Any health claims or descriptors such as healthy, health, etc., on food labels or in advertisements are not allowed. Any claims for a food product that involve prevention of a disease or modification of an organic function, for example, lowering serum cholesterol, are deemed to bring the product within the definition of

a drug. The rationale behind this is that the public should not be self-medicating for diseases.

17.5.1 H EALTH C LAIMS FOR F UNCTIONAL F OODS

In spite of the conservative nature of Canadian regulations, in 1996, Health Canada initiated a national debate concerning functional foods and health claims. In 1998, the Health Protection Branch of Health Canada established its final policy, proposing

a policy framework to address the use of health claims on nutraceuticals/functional foods and related products that are currently regulated as either food or drugs. 32 This paper proposes that use of structure–function and risk reduction claims for foods should be permitted if supportive evidence of efficacy is produced. Other claims, regarding cure, treatment, mitigation and illness prevention, would continue to be regulated as drugs. The proposed regulatory framework was designed to exempt foods bearing certain “drug-like health claims” from the provisions of the act relating to drugs and to maintain them under the provisions of the act relating to foods to manage the health risk usually associated with foods.

Food Regulations

17.5.1.1 Product-Specific Health Claims for Foods

Another initiative of Health Canada related to health claims for foods is a recent proposal for the product-specific authorization of health claims for foods, published

in October 2001. 33 It has been proposed that the manufacturer of 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, or reducing the risk of or facilitating the dietary management of disease or health-related conditions be required to submit detailed information to support such an effect being advertised or offered for sale.”

A food meeting the criteria as supported by scientific evidence may bear a label health claim as identified by a Claim Identification Number (CIN). The CIN is granted on a product-by-product basis, and the health claim is authorized to a single food product. It cannot be used by similar foods unless acceptable supporting evidence is provided. To obtain a CIN for a specific health claim, a submission by the food’s manufacturer to Health Canada is required. The conditions of submission are specified in the proposal and must contain a number of specifications, including the food product’s composition, intended use, and target; the proposed claim and information required for assessing the product’s safety; the claim of validity; and the quality assurance of the product. Once the application is made, a CIN may be granted within 90 days of receiving the submission. However, at this time it is unclear how a health claim may be authorized without amending Schedule A of the Canadian Food and Drug Act.

17.5.1.2 Foods for Special Dietary Use

Foods for special dietary use are regulated under Division 24 of Part B of the Food and Drug Regulations 31 and refer to foods

“... that have been specially processed or formulated to meet the particular requirements of a person (a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or (b) in whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods.”

Health Canada proposed that different health claims may be used for this cate- gory of foods as part of the dietary management of a disease or health condition. For example, a product that lowers the blood cholesterol level may bear the following information on the label:

This product is a food for special dietary use. It contains at least X grams per serving of ingredient Y (e.g., fiber). When eaten twice a day for a daily total of not less than

Z grams of Y, this product has been shown to lower elevated blood cholesterol [in naming the target population where applicable]. Consult your doctor when using this product as part of dietary management of high blood cholesterol.

Functional Food Carbohydrates

17.5.1.3 Generic Health Claims

In 2000, Health Canada announced approval for the use of five generic diet-related health claims. These five claims were adopted from the U.S. NLEA list after review- ing the scientific evidence supporting the U.S. generic health claims. The process involved Canadian experts who published a report for public review. Subsequently, in January 2003, regulations amending the FDAR to include five health claims became law: 34

1. Sodium and hypertension

2. Calcium and osteoporosis

3. Saturated and trans fat and cholesterol and coronary heart disease

4. Fruits and vegetables and cancer

5. Sugar alcohols and dental caries Generic claims apply to a food or a group of foods that have compositional

characteristics that contribute to a dietary pattern associated with reducing the risk of disease or health condition. Once a claim is authorized, any food that meets the specified conditions for composition and labeling may carry the claim without further assessment. It is worthwhile to note that two carbohydrate-relating health claims — “fiber-containing grain products, fruits, and vegetables and cancer” and “fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease” — have not yet been authorized; however, they are being further reviewed and may be approved in the near future.

17.5.2 N OVEL F OODS

The Novel Foods Regulations became law in Canada in 1999. 35,36 They have been primarily established to handle and regulate marketing of genetically modified foods

or, in broader terms, foods derived from biotechnology. In fact, most of the appli- cations for approval under Novel Foods in the past decade were related to genetically modified foods. However, these regulations are open to foods other than just the genetically modified organism (GMO) foods, as defined below (B.28.001):

1. A substance, including a microorganism, that does not have a history of safe use as a food

2. A food that has been manufactured, prepared, preserved, or packaged by

a process that:

i. Has not been previously applied to that food

ii. Causes the food to undergo a major change Most of all functional foods would correspond with this definition, and therefore,

this set of regulations may be used for the premarket safety assessment of functional foods. The information requirements for the assessment of novel foods are contained in the Guidelines for the Safety Assessment of Novel Foods that were published in 1994 by Health Canada. Health Canada is currently reviewing these guidelines to

Food Regulations

reflect the advancement of methods and knowledge regarding product review. The process for novel food review is a notification process rather than a traditional premarket approval process. The review of all relevant technical information sub- mitted in support of a novel food is much faster than that for food additives or ingredients. Health Canada is required to respond to the novel food application within 45 days. If additional information is required, Health Canada has a further

90 days in which to respond. It is worthwhile to note that the approval process does not require a public consultation or an amendment to the existing regulations, which usually takes between 1and 2 years. However, it is only used for the safety assessment of foods outside of the health claims that bare important characteristics of functional foods.

17.5.3 N ATURAL H EALTH P RODUCTS R EGULATIONS

On January 2004, after nearly a decade of discussion, public consultation, and publication in Canada Gazette II, the Natural Health Products Directorate (NHPD)

began its operation. 37 The NHPD is responsible for regulating dietary and nutritional supplements under the broad jurisdiction of Canadian drug legislation. Natural health products are now 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 — that is, claims that were only allowed in Canada for drug products. They may also be used in correcting organic functions in humans or maintaining or promoting health or otherwise modifying organic functions in humans. Unlike the regulations in many other countries, NHPD regu- lations allow for a full range of health claims, including structure–function, risk reduction, and therapeutic/treatment.

The category of natural health products includes: 37

1. A plant or plant material, an alga, a bacterium, a fungus, or a nonhuman animal material

2. An extract or isolate of a substance described above, the primary molec- ular structure of which is identical to that which it had prior to its extrac- tion or isolation

3. Any vitamins that are listed in the NHPD regulations

4. An amino acid, an essential fatty acid, a synthetic duplicate of a substance described above, a mineral, and a probiotic

Natural health products do not include:

1. A substance set out in Schedules C and D of the Food and Drug Act

2. A substance regulated under the Tobacco Act

3. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act

4. A substance that is administered by puncturing the dermis

5. An antibiotic prepared from an alga, a bacterium, or a fungus, or a synthetic duplicate of that antibiotic

Functional Food Carbohydrates

Although the regulations are not very clear regarding the delivery vehicle of a compound in question, they cover a range of acceptable dose forms, including capsules, tablets, and liquids. They also do not exclude the use of food matrices such as snack bars or beverages, as long as they are clearly defined with dosages. Traditional food forms are precluded from the use under the NHPD regulations. All products approved under the NHPD carry a unique identification number, in much the same way as pharmaceuticals. The product has either a NPN (Natural Product Number) or DIN-HM (Drug Identification Number — Homeopathic Medicine) on the label. These numbers let the consumer know that the product has undergone and passed a review of its formulation, labeling, and instruction for use. In addition, the numbers facilitate adverse event monitoring and allow easy recall of products for which safety concerns emerge. All manufacturers of natural health products will be required to notify the agency of their marketed products and will have 2 years to bring their operations into compliance with the regulations and obtain the appropriate product licenses.