Regulation of Dietary Supplements in Canada
© Eileen McMahon, Deeth Williams Wall1
Table of Contents
- The Interim DIN Enforcement Directive and Therapeutic Products Compliance Guide
- The House of Commons Standing Committee on Health
Canadians are exposed to US laws and US products through spill over advertising from the US into Canada and because of the flow of persons and products across our borders. With the passage of the Dietary Supplement Health and Education Act (1994) in the United States, and the availability of dietary supplements in the US, Canadians have become more aware that dietary supplements available in the US are not available in Canada.
Canada's Food and Drugs Act and Regulations currently classify any product that makes a therapeutic claim as a "drug". Drugs cannot be marketed in Canada unless they have been pre-approved by the Health Protection Branch and issued a drug identification number or DIN. This article explores the current law regulating dietary supplements in Canada and the changing face of that regulation.
Canada's Food and Drugs Act (the "Act") governs the sale of foods and drugs in Canada.
The Act defines "food" as follows:
"food" 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 whatsoever;
The Act defines "drug" as follows:
"drug" includes any substance or mixture of substances manufactured, sold or represented for use in
the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals,
restoring, correcting or modifying organic functions in human beings or animals,
disinfection in premises in which food is manufactured, prepared or kept.
The classification of a product as a food or drug is based primarily on the nature of the claims made for the use of the product. However, the ingredients of a product can also determine its classification. For example, products containing certain amino acids or vitamins are automatically classified as drugs, regardless of whether the products make a therapeutic claim.
The advertising for many dietary supplements offered for sale in Canada claims that the supplements have certain therapeutic effects. As such, these supplements become encompassed by the definition of "drug" in the Act. Under Canada's current law, these supplements cannot be sold in Canada without a drug identification number or DIN.(2)
In Canada, establishments at which chemical or biological drugs are manufactured must be licensed. In the fall of 1997, the Canadian government proposed to extend this requirement to establishments at which dietary supplements are manufactured.
Intense pressure from industry, retailers and users of dietary supplements caused the government revoked this proposal. Instead, the Minister of Health called upon a House of Commons Standing Committee on Health to consult, analyze and make recommendations regarding the regulatory framework governing "natural health products".
The Interim DIN Enforcement Directive and Therapeutic Products Compliance Guide
While the government is determining how to regulate natural health products, the Health Protection Branch has implemented interim policies. Effective January 1, 1998, an Interim DIN Enforcement Directive (the "Enforcement Directive") and a companion Therapeutic Products Compliance Guide (the "Compliance Guide") were issued. These documents are not law, and are interim in nature pending completion of the review of the regulatory framework for natural health products by the Canadian government.
The Enforcement Directive is a guide for Health Canada inspectors in dealing with drug products without a valid DIN. According to the Directive, if dietary supplements are viewed by enforcement officials as "products subject to special measures", the Directive prescribes that the only enforcement activity that will be taken is "informing the responsible company of the appropriate DIN requirements in order to obtain voluntary compliance."
The Directive defines "products subject to special measures" as follows:
Traditional medicines (i.e. traditional herbal medicines as well as traditional medicines such as Chinese, ayurvedic (East Indian) and aboriginal (North American) medicines), homeopathic preparations and vitamin and mineral supplements for human use, when in dosage form and for which prescriptions are not required.
"Traditional medicines" are in turn defined as drugs that:
contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and
the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards.
Many dietary supplements are encompassed by these definitions. First, some are vitamin supplements for human use. Second, some are "traditional medicines" because they consist of a "plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed" and because they have "historical and ethnological evidence" to support the medical uses of the supplements.
Certain characteristics and ingredients that will take a drug out of the definition of products subject to special measures and trigger full enforcement of the DIN requirements. These include the following:
claims to Schedule "A" diseases (serious diseases);
a requirement that the product be sterile;
a drug containing substances found in certain Schedules to the Regulations;
a drug containing prohibited substances (essentially poisonous substances);
inclusion of certain other substances "not covered by any of the previous criteria (but) that have been found to represent an unacceptable potential health risk"; and
the inclusion of certain vitamins or minerals, vitamins or minerals from certain sources, or exceeding maximum amounts of certain vitamins or minerals.
The House of Commons Standing Committee on Health
On November 4, 1998, the House of Commons Standing Committee on Health tabled its Report in Canada's parliament. The Report is called "Natural Health Products -- A New Vision". Before issuing the Report, the Committee heard from over 300 witnesses and received more than 1,000 submissions on how natural health products should be regulated in Canada.
What are natural health products?
Unfortunately, the Report does not define "natural health products". As a result, it is difficult to determine whether the Report is confined to traditional medicines, homeopathic preparations and vitamin and mineral supplements or whether it also encompasses nutraceuticals, functional foods and dietary supplements.
The Report recognizes that "natural health products" are neither foods nor drugs. They are a category of products unto themselves. The Report proposes that these products be regulated by a distinct agency called the Natural Health Products Directorate (NHP Directorate) within Canada's Health Protection Branch, but separate from the Therapeutic Products Directorate and the Food Directorate. Staff within the NHP Directorate would be knowledgeable about natural health products. This recommendation was a result of criticism that staff within the HPB, with a chemical and biologic perspective, are ill-suited to regulate natural health products.
The Report rejects a notification system in which manufacturers of natural health products would simply notify the government once they market the products in Canada. Instead, the Report proposes that no new natural health product be sold in Canada without a license from the NHP Directorate to market the product. The Report suggests a 30 day pre-approval period. Pre-market licensing would be based upon monographs containing standardized product information. Products would be assessed against these monographs. Where monographs do not exist, the manufacturers would submit evidence to the NHP Directorate in support of a license.
The Report recommends that establishments at which natural health products are manufactured be licensed and that manufacturers be required to comply with good manufacturing practices. However, the GMP standards would be less than the GMP standards for drugs.
Claims on labels
The Report accepts the premise that all types of claims -- structure-function, risk reduction and treatment -- be permitted on labels for natural health products. However, before making any claims, the manufacturer would need to submit to the NHP Directorate the evidence to support the claims. The evidence would be reviewed by the NHP Directorate. The level of review would be proportional to the risk. For example, a claim that a natural health product treats cancer would undergo a more detailed and lengthy review than a claim that a natural health product helps promote the health of kidneys.
Types of evidence to support claims
The Report recommends that there be flexibility in the type of evidence supporting claims on labels. It rejects the notion that only clinical data could support the claims and suggests that scientific studies and historical use would be acceptable evidence.
Every natural health product would be required to have a label identifying:
- the product
- shelf life
- special storage conditions
- details on the amount of ingredients
- how to take, how much to take, when and when not to take the product
- what the product does
- claims for the product
- evidence supporting the claims (i.e. clinical studies, scientific data, historical data)
Importation from the US into Canada for personal use
Under the current Food and Drugs Act, no person can import for sale a drug unless the drug has a drug identification number. A person may, however, import a supply of product, approved in the US but not in Canada, for their own personal use. The Health Protection Branch considers a quantity in excess of a three-month supply to be importing for the purposes of sale.
The Report recommends continuing this "personal use exemption", despite Canadian manufacturers complaints that Canadian consumers are importing US products to the detriment of Canadian manufacturers.
The Report is not law. The Canadian government is to respond to the Report by April 4, 1999. The Minister of Health, however, has indicated that he will move quickly to address the recommendations in the Report. While the Minister considers the Report and whether to implement a new law for natural health products, the status quo continues.
It is not certain that the Report will become law. The opposition parties dissented strongly to the Report. One party indicated that the Report proposes to give too much control to the government in regulating safe products. The Report, if implemented, may closely resemble Canada's drug-approval system, although this is not what the House of Commons Committee intended.
The Report recommends a six-month phase in period, after the Report becomes law.
Eileen McMahon is a partner of the Toronto law firm, Deeth Williams Wall. She practises food and drug law.
The Food and Drugs Act is a criminal statute. Violations of the Act and the Regulations can result in a maximum fine of five thousand dollars ($5,000.00) and imprisonment for up to three years or both.
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