Look for Canada’s most popular herbal remedy, Echinacea, in any drugstore and you’ll find a variety of brands accompanied by an equally wide range of price tags. But unlike the conventional medicine displayed in the next aisle over, Echinacea is an unregulated, poorly labeled product that adheres to no particular standard.
Echinacea extract pills and fresh Echinacea flower
In other words, the tiny bottle of tincture you pay $10 to $20 for to ward off colds may not be what it claims to be or, even worse, may be harmful to your health. Your decision is more likely to be based on what brand worked best for the store clerk than on any information on the label.
Health Canada aims to put an end to this haphazard form of self-medication by introducing new regulations for licensing and monitoring the natural health products industry. Over the next three years, the ministry will spend $7 million to establish a new Office of Natural Health Products and another $3 million to research herbal remedies and other alternative medicines.
The new regulatory framework will be similar to the one that governs conventional over-the-counter drugs, but will give natural health products a classification of their own.
Most consumer groups and organizations that support alternative medicine are enthusiastic about the impending regulation. They say the booming market for natural health products has created a demand for more information about the safety, quality and efficacy of these remedies.
“People are scrambling to get information, mainly from informal sources,” says Gerry Harrington, director of communications for the Nonprescription Drug Manufacturers Association (NDMA) “This process will improve the labeling and consistency of products to include believable, understandable and well-based claims.”
The labels will also have clear directions about how to use the drug and warnings about potential side effects.
In the case of Echinacea, these warnings will be directed at people with autoimmune disorders such as lupus, multiple sclerosis and rheumatoid arthritis because the herb boosts the immune system.
The regulations may also help to prevent sales of natural stimulants such as “herbal ecstacy”, a mixture of green-tea extracts and herbs that is used as a legal alternative to ecstasy, the synthetic raver drug, in the United States. Although the USA’s Food and Drug Administration (FDA) is investigating illnesses and deaths related to the use of herbal ecstacy and similar products, the regulators are powerless to ban the substance unless it can prove it is unsafe. In Canada, the onus will be on the manufacturer to prove the product is safe and effective.
But not everyone is happy about the prospect of regulation in Canada. The Health Action Network (HANS), a consumer health organization with about 6,000 members, says the new rules will increase the price of vitamins and herbs, create an unnecessary burden for taxpayers and make many natural products available by prescription only.
“Canadians can expect a long list of natural health products to go under the prescription-only umbrella and at grossly inflated prices,” writes Dr. Zoltan Rona, past president of the Canadian Holistic Medical Association, in a recent commentary for HANS.
But both Harrington and Joan Roberts, director of government relations for the Canadian Naturopathic Association, say this fear is unfounded.
“You will never have to purchase a product like Echinacea by prescription,” says Roberts. “Nobody wants that to happen.”
Health Canada’s regulatory initiatives, which cover traditional herbal medicines, traditional Chinese, East Indian and Native North American medicine, homeopathic preparations and vitamin and mineral supplements, are a direct response to the skyrocketing demand for natural health products in this country. Almost a third of Canadians used an herbal remedy in the 12 months prior to April 1998, compared with only 15% during the same period in 1996, according to annual surveys conducted by AC Nelson and NDMAC.
The most popular herb is Echinacea, an immune system booster used to ward off colds and flu, which was taken by close to 55% of herbal remedy users. Garlic is a close second, with ginseng and chamomile nabbing third and fourth place respectively.
The new federal program will also test claims about the benefits of individual remedies.
The jury is still out on the efficacy of Echinacea. More than 350 scientific studies completed over the years suggest that certain types of this herb do indeed boost the immune system by increasing the number of immune cells and stimulating the production of interferon. But a recent study published in the November/December 1998 issue of Archives of Family Medicine failed to prove that the herb prevents colds and flu.
The study divided 302 healthy volunteers into three groups. The first group was given an extract from Echinacea purpurea roots, the second group an extract from Echinacea angustifolia roots and the third a placebo.
In the placebo group, 36.7% developed an upper respiratory tract infection within just over two months compared to 32.0% in the E. angustifolia group and 29.3% in the E. purpurea group.
In their conclusions, the authors said their study and others like it suggest that Echinacea might reduce the risk of infection by about 10-20%, but concluded that larger sample sizes would be needed to prove this effect.