In the first of a two-part series on the changing regulatory environment in Canada, Kelley Fitzpatrick describes the regulatory background and assesses new proposals for health claims on natural health products
The functional foods, nutraceuticals and natural health products (NHP) industries have garnered a great deal of attention and enthusiasm from the government, agri-food sector and research community in Canada. In 2001, Canadians purchased approximately $4.2 billion worth of dietary supplements, nutraceuticals and functional foods products, compared with $3.9 billion in 2000.1 This translates into nearly $140 per capita spending, a 130 per cent increase in only four years.
According to a recent government study, some (CA)$1 billion in farm production value supplies ingredients for functional foods, nutraceuticals and NHP.2 This estimate does not include the marine industry, which presents a significant opportunity for products such as omega-3 fatty acids and glucosamine.
Another study noted that lifestyle-related chronic disorders are a major component of increasing health care expenditures in Canada.3 The study concluded that the proportion of disease onset attributable to diet is approximately 40 to 50 per cent for cardiovascular disorders and diabetes, 35 to 50 per cent for all cancers and 20 per cent for osteoporosis.
The Canadian Food and Drugs Act and Regulations was passed in 1953 and through its definitions of 'food' and 'drugs,' this legislation currently restricts health-related claims for foods, food ingredients and NHP. Current legislation, limiting the development of health claims, prohibits the sale or advertisement to the general public of any food, drug, cosmetic or device that supposedly treats, cures or prevents diseases or disorders, including heart disease, diabetes, cancer, hypertension, obesity and arthritis. These are the most common causes of morbidity and mortality in Canada and are diseases for which functional foods and NHP have the potential to be most beneficial. Claims for physiological effects that relate to these conditions, such as lowering serum cholesterol or glucose, also are prohibited on product labels and in advertisements.
In order for health claims to appear, lawmakers would have to allow claims for these conditions or physiological effects related to these diseases.
The current regulatory environment in Canada is believed to have stifled innovation, competition and investment in the industry. A report commissioned by Agriculture and Agri-Food Canada and released in 2001 concluded that Canadian regulations have been a burden on the NHP industry that has resulted in lost opportunities and sales. The report also cites disadvantages to consumers, who have fewer functional foods and NHP choices and much less information to assist them in making informed purchases and using products properly.4 In 1996, Health Canada recognised that the regulatory framework does not support labelling and advertising of the potential health benefits of NHPs to consumers and began a series of regulatory reviews for these product categories, with progress now being made in some areas.
Natural Health Products
Canada's Office of Natural Health Products was formed in March 1999 to establish and implement a new regulatory framework for NHPs. In 2001, it was named the NHP Directorate (NHPD), a parallel and equal department to Health Canada's Food Directorate and Therapeutic Products Programme. The Directorate is making significant progress in the area of NHP regulation to allow health claims and increased consumer access. Other jurisdictions are watching with interest as Canada moves forward with new regulations for this category.
In December 2001, proposed regulations for NHPs were published in Canada Gazette Part I as the first step toward amendments to the Foods and Drug Act and Regulations.5 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, sanitation programme; operations—quality assurance, stability; records—sterility, lot or batch samples and recall reporting), standards of evidence for safety and health claims, and labelling and packaging.
Previously, 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 physiological benefit or provide protection against chronic disease.' Health Canada decided that the product category of nutraceuticals will be part of NHP regulations.5
Under these proposals, NHP will include homeopathic preparations, substances used in traditional medicine, such as minerals or trace elements, vitamins, amino acids, essential fatty acids, or other substances derived from botanicals, animals or micro-organisms.
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 (claims that are currently allowed in Canada only for drug products); re-sorting or correcting organic functions in humans; or maintaining or promoting health or otherwise modifying organic functions in humans. In order 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 in order 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 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 randomised controlled trials, or at least one well-designed (multi-centre) randomised 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 (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.'
Better Than The US?
In comparing the Canadian NHP regulations to the US Dietary Supplements Health and Education Act (DSHEA) of 1994, there is a possibility that NHPs sold in Canada could carry a wider range of health claims than their US counterparts. Unlike dietary supplements regulated under DSHEA, there will be requirements for product and site licenses for NHPs sold in Canada.
Despite the fact that NHPs will be regulated as a subset of drugs, there are concerns that such products will not make certain label claims, even if there is scientific evidence to justify them within the restrictions of Schedule A of the Food and Drugs Act. Early 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 Programme and in response to the House of Commons Standing Committee on Health's report on NHPs. The Working Group will make proposals with respect to the criteria that could be used for determining which diseases need to be included in Schedule A and its modifications.
The new regulations will not become law until they are published in Canada Gazette Part II, which is expected this summer. For now, most NHPs are treated by Canadian regulatory authorities as 'Products Subject to Special Measures' and are subject to Health Canada's Interim DIN Enforcement Directive.
Kelley Fitzpatrick, MSc, is the marketing and research development manager for Richardson Centre for Functional Foods and Nutraceuticals at the University of Manitoba, Manitoba, Canada. [email protected] www.umanitoba.ca/afs/ffnc
1. Anon. 1998. Nutrition Business Journal. Vol. 3, No. 9
2. Potential benefits of functional foods and nutraceuticals to the agri-food Industry in Canada. Report submitted to Agriculture and Agri-Food Canada, Food Bureau, by Scott Wolfe Management, 2002 Mar.
3. Potential benefits of functional foods and nutraceuticals to reduce the risk and costs of diseases in Canada. Report submitted to Agriculture and Agri-Food Canada, Food Bureau, by Bruce Holub, PhD, Guelph University. 2002 Jun.
4. Jarvis D, et al. 2001. Business and Market Impact of the Food and Drugs Act and Regulations on Functional Foods in Canada. Commissioned by Agriculture and Agri-Food Canada to Intersect Alliance Inc. Ottawa, Ontario.
5. Health Canada. Natural Health Products Regulations. Canada Gazette Part 1, 2001 Dec 22. (http://canada.gc.ca/gazette/part1/pdf/g1-13551.pdf).