Proposed natural health product regulations are a cure worse than the illness
For Release: 21 February 2002
VANCOUVER, BC The creation of the government's Natural Health Products Directorate and further regulation of natural health products is a waste of time and money according to a new study, "A Cure Worse than the Illness," released today by The Fraser Institute.
In 1997, the Fraser Institute calculated that 73 percent of Canadians had used at least one complementary medicine at some point in their lives and that 50 percent had used one in that year. In total, it was estimated that Canadians spent $3.8 billion that year on complementary medicine.
"The risks posed to Canadians by natural health products are minimal," says the study's author, health economist Cynthia Ramsay. "Simply because more people are using complementary medicines such as echinacea and other herbal remedies does not warrant the creation of a whole new regulatory body to oversee their use."
Do consumers need more protection?
In 2001, adverse reactions to herbal preparations amounted to only 0.38 percent of all adverse reactions reported in the United Kingdom. In Australia, natural health products (NHPs) accounted for 1.16 percent of the total adverse reactions to NHPs and drugs in 2000. In the United States, dietary supplements represented only 7.4 percent of the American government's safety advisories in 2001. As well, statistics on poisonings in the United States support the view that NHPs are not substances that require extensive regulatory intervention: in 1998, 45 people died from a reaction to Aspirin, there were 10 fatalities as a result of homeopathic or dietary supplements and two deaths from vitamins.
More onerous regulations are costly and they can also mean that approval times for products take longer. "Just as there are potential concerns with rushing the approval process, there are also costs to delaying it, such as lives that could have been saved, or improved, if the product had been publicly available. There has been no attempt by the NHPD to weigh these costs in its decision to regulate NHPs," says Ramsay.
The international evidence
In most countries including Canada, a natural health product is considered a drug when the manufacturer claims that it improves health. An NHP is considered a food when no such health claims are made. Most countries state that they wish to ensure public access to these products and, therefore, they require lower standards of efficacy for NHPs than drugs though they demand the same levels of evidence with respect to quality and particularly safety for both types of substance. All countries require manufacturers of drugs and NHPs to meet good manufacturing practices.
In light of the international evidence, the study makes several key recommendations:
1. Enforce current regulationsCanada already has regulations to deal with the contamination and adulteration of NHPs. Instead of pumping money into new directorates or regulations, there should be greater enforcement of the current regulations, more spot checks of products on the shelves. The vast majority of NHPs can be monitored through self-regulation-producers of organic food, for example, have developed standards and certify products that meet them.
2. Allow the free flow of informationThe vast majority of NHPs pose minimal safety risk. Manufacturers of these products should be permitted to make health claims about their products. 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.
3. Let the market provide information on the interaction between drugs and herbsSome NHPs produce adverse reactions when mixed with pharmaceutical drugs. It is unreasonable to expect all foods or drugs to be labelled with every possible contraindication. The market should be left to determine what is the right amount of information. "Already, there are many recognizable and reliable sources on the contraindications of NHPs. It is hard to see how increased labelling requirements will improve the situation," says Ramsay.
4. Measure the costs and benefits of regulating NHPsThe analysis of the costs and benefits of the proposed regulatory reforms provided by Health Canada in its regulatory impact analysis statements (RIAS) is of limited value. There must be concrete data to support the claim that the situation will be improved by the regulations and that their costs are worthwhile.
Established in 1974, The Fraser Institute is an independent public policy organization based in Vancouver with offices in Calgary and Toronto.