February 2002
Overkill: The Regulation of Natural Health Products in Canada
by Cynthia Ramsay
The Canadian government created the Natural Health Products Directorate (NHPD) in 1999 and provided it with some $7 million over three years to establish the new office and another $3 million to fund research on natural health products (NHPs) and complementary medicines. The NHPD was charged with creating a new regulatory framework for NHPs and, after several years of public consultations, the directorate's proposals were published in the Dec. 22, 2001, edition of the Canadian Gazette, Part 1. Canadians have 90 days from that date to provide their comments on the proposals.
One of the main stated reasons for increasing the regulatory standards for NHPs is that more people are using them. Is this a good enough reason? Are people being harmed by NHPs?
The proposed regulations
Under the current regulations—the Food and Drugs Act (FDA)—NHPs are considered drugs when there are health claims made about them, and foods when there are not. For example, a clove of garlic is considered a food—it is grown, sold, and represented for use as food. However, when it is said by the manufacturer to help lower cholesterol or prevent colds, as garlic is, it is a drug. If garlic is put into pill form, it is considered a drug, since it is not likely that a pill is being sold for use as food.
The proposed definition of a natural health product recognizes that an NHP is a substance(s) 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. NHPs would include homeopathic preparations, traditional medicines, minerals, vitamins, amino acids, and a few other substances.
Allowing NHPs to be used to treat a disease or illness is a bold move for the directorate. However, the NHPD's proposed framework regulates NHPs similarly to the way in which drugs are regulated by the FDA: Part C, Divisions 1, 1A and 2 in particular. To be sold in Canada, an NHP manufacturer will need a product license, all persons in the manufacturing and distribution chain will need a site license, and all sites will have to follow good manufacturing practices (which include several sanitary measures).
The regulations are rigorous and will end up being costly: compliance costs imposed on manufacturers will be passed on to retailers, who will pass them on to consumers. The NHPD's cost-benefit "analysis" of the regulations notes this fact, but doesn't provide any dollar figures. Nor, after concluding that the benefits outweigh the costs, does the NHPD provide any tangible evidence on how Canadians' health will be improved by the regulations.
Protecting consumers
An "adverse reaction" is a noxious and unintended response to an NHP that occurs at any dose used or tested for the diagnosis, treatment, or prevention of a disease or for modifying an organic function. What is the threat to consumers' health from NHPs?
In Canada, there were 1,197 deaths in 1997 attributed to accidental or purposeful poisoning by drugs, medicaments, and biologicals (Statistics Canada, 1999), and there were 7,361 reports of adverse drug reactions in 2000 (Health Canada, 2001). People have life-threatening allergic reactions to peanut butter, shellfish, and many other foods. Motor vehicle accidents and accidental falls claim more lives per year than poisoning by drugs, and the limited data available indicate that adverse reactions to NHPs are much fewer than those for drugs.
The only country for which data have been collected for a number of years on adverse reactions to herbal preparations is the United Kingdom. In 2001, adverse reactions to herbal preparations amounted to only 0.38 percent of all adverse drug and/or herb reactions reported in the United Kingdom. From 1996 to 2001, this ratio never rose above 0.5 percent (United Kingdom, 2001).
The experience in Australia is similarly telling. In 2000, there were approximately 150 adverse reaction reports concerning NHPs and 12,744 adverse drug reactions. NHPs accounted for 1.16 percent of the total adverse reactions (Australia, 2001).
More evidence of the relative safety of NHPs comes from the United States. In 2001, dietary supplements represented 7.4 percent of the US Food and Drug Administration's safety advisories regarding drugs, biologics, and supplements (US FDA).
As well, statistics on poisonings in the United States support the view that NHPs are not substances that require extensive regulatory intervention. Data from the 1999 American Association of Poison Control Centres indicate 45 deaths reported to be the result of poisoning from Aspirin only (not in combination with other substances). Antidepressants (eg., amitriptyline, Lithium) were linked to 153 deaths; cardiovascular drugs (eg., beta blockers, antihypertensives) to 127; and cough and cold preparations to five. Homeopathic and/or dietary supplements were the reported cause of 10 poisoning deaths; vitamins A, C, and E were related to none; and vitamins as a whole (multivitamins, and vitamins A, B3, etc.) were responsible for two.
In addition to potential adverse reactions to the NHPs themselves, there is the possibility of an NHP-drug interaction when people are taking both an NHP and a prescribed medication. Many of these interactions enhance the beneficial effects of the drug or reduce the drug's side effects; others magnify the drug's negative side effects, and some are life-threatening. But it is hard to see what information on these interactions the NHPD regulations can add to that not already available in, for example, the American Botanical Council's (ABC's) translation of the German health department's Commission E monographs; they comprise detailed data on hundreds of herbs. As well, there is the ABC's Botanical Safety Handbook that explains more than 500 herbs, web sites such as pdr.net (run by the publisher of the Physician's Desk Reference) and other resources.
Recommendations
Enforce current regulations
In the public hearings regarding the regulation of NHPs, there was much discussion about the need for a certification program on botanical identity, so that when consumers buy a product they can be assured that what is in the bottle is what the label says is in the bottle. As well, many of the adverse reactions (including death) from NHPs were attributed to adulteration and contamination, rather than to the NHP's active ingredient(s). Part 1, sections 4, 5, 8 and 9, of the FDA prohibit the adulteration of, and require the sanitary preparation of, foods and drugs. There should be greater enforcement of these regulations and more spot checks of products on the shelves, but this task does not need to be performed by government. Most NHPs can be monitored through self-regulation—the organic food industry, for example, has developed standards and certifies products that meet them.
Allow the free-flow of information
There are many sources of reliable information on NHPs. If multiple certification bodies or random-testing programs were allowed to proliferate, there would be even more. The manufacturers of the vast majority of NHPs, which pose minimal safety risks, should be permitted to make claims about their products' benefits. For the small percentage of NHPs that are toxic and high-risk, there could be somewhat stricter regulations. Restrictions on advertising for NHPs (and prescription drugs) should be lifted to increase the amount of information available to consumers about these products.
Let the market provide drug-herb interaction information
Some NHPs produce adverse reactions when mixed with pharmaceuticals: grapefruit can hinder the liver's ability to metabolize certain drugs and large amounts of fibre can decrease the absorption and distribution of any drug, especially anti-depressants (National College of Naturopathic Medicine, 1999). It is unreasonable to expect all foods or drugs to be labelled with every potential contraindication. Consumers should be asking their health care practitioners about the products they are taking, practitioners should be up to date on the latest medical data, and NHP and drug manufacturers should provide as much research on the effects of their products as they can. What the right amounts of information are, the market should be left to determine. Already, there are many recognizable and reliable sources on the contraindications of NHPs. It is hard to see how increased labeling requirements will improve the situation.
Measure the costs and benefits of NHP regulation
Health Canada has supplied cost-benefit analyses of limited value with respect to the proposed reforms. Statements such as "costs placed on industry to comply with the regulations would eventually be passed on to the consumer" are not acceptable. There must be data to support the claim that the situation will be improved by the expenditure.
Selected bibliography
American Association of Poison Control Centres (2000). Toxic Exposure Surveillance System Annual Report, 1999. Washington, D.C. Available on the internet at www.aapcc.org (as of Dec. 15, 2001).
Australia, Government of (2001). Australian Therapeutic Goods Administration, Adverse Drug Reactions Unit. Woden, ACT. E-mail correspondence (Aug. 8).
Blumenthal, Mark (2000). "Interactions Between Herbs and Conventional Drugs: Introductory Considerations." HerbalGram 49. Austin, Texas: The American Botanical Council.
Health Canada. (1981). Departmental Consolidation of the Food and Drugs Act and of the Food and Drug Regulations. Ottawa: Minister of Supply and Services Canada.
Health Canada (2001). Therapeutics Products Program. Canadian Adverse Drug Reaction Newsletter 11(4). Ottawa (October).
National College of Naturopathic Medicine (NCNM) (1999). "Doctors, Patients Need to Know Drug-Herb Interaction." Drug-Herb Interaction. Portland, Oregon: NCNM (July 12).
Natural Health Products Directorate (2001). "Natural Health Products Regulations." Canada Gazette, Part 1. Ottawa (Dec. 22): 4912-4971.
Pharmacovigilance Group, Post Licensing Division, Medicines Control Agency (2001). London, England. E-mail correspondence (Nov. 5).
Statistics Canada (1999). Mortality–Summary List of Causes, 1997. Health Statistics Division: Ottawa (July).
United States Food and Drug Administration (US FDA). Web site, www.fda.gov (as of Dec. 21, 2001).
Cynthia Ramsay is a Vancouver-based consultant specializing in health economics. She is the author of the forthcoming Fraser Institute publication A Cure Worse than the Illness: Canada's Proposed Regulatory Framework for NHPs and author of Beyond the Public-Private Debate. She recently completed a chapter for a forthcoming book on health care, and a report for the Commission on the Future of Health Care in Canada.
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