Companies that sell natural health products will soon have unprecedented freedom to promote the ability of vitamins, herbal supplements and non-prescription drugs to prevent serious diseases and medical conditions, including cancer, heart disease and arthritis.
The changes to the federal rules, which take effect June 1, represent a significant boost for the natural health industry, which is eager to increase its credibility and capitalize on a booming market for vitamins and botanical supplements by directly marketing their health claims to consumers.
But medical experts and consumer advocates warn the federal government’s decision could result in a flood of deceptive claims about natural health products that are backed up by inadequate or even flawed scientific evidence.
“It seems to me they’re [Health Canada] authorizing wholesale misleading claims,” said Bill Jeffery, national co-ordinator for the Centre for Science in the Public Interest. “They’re giving industry even more latitude and they’re prepared to approve even more impressive claims about more worrisome diseases with very little evidence.”
Natural health products are regulated by Health Canada and include vitamins, minerals, herbal supplements and homeopathic medicines such as echinacea, St. John’s wort and vitamin D.
Companies have traditionally been allowed to make limited claims about the ability of some products to promote good health or prevent some mild conditions, such as the common cold.
But until now, they have been strictly prohibited from making any claims about serious diseases, including asthma, cancer and diabetes. The restrictions were designed to prevent companies from making false or misleading claims directed at people with serious diseases or medical conditions, according to Health Canada.
The new rules are set to change all that to reflect a growing demand for information about the possible benefits of herbal remedies. Consumers want to know, for instance, that vitamin D may reduce the risk of cancer or that aspirin can help prevent heart disease, said Supriya Sharma, director-general of Health Canada’s Therapeutics Products Directorate.
Companies in the industry say the changes will help Canadians choose products that have the potential to help them.
“Consumers want to understand the products that they’re purchasing and what the benefits of those products are,” said Penelope Marrett, president of the Canadian Health Food Association.
But Lloyd Oppel, physician at the University of British Columbia Hospital who evaluates evidence behind medical claims, says the regulations are only about making manufacturers happy.
“They have nothing to do with protecting Canadians,” he said. “If you tell people that they can do certain things with medications, it’s going to at least misinform them, maybe spend their money poorly and may delay getting proper care.”
One of the major problems Dr. Oppel and other medical experts cite with allowing companies to say their products prevent serious diseases is that scientific proof is scant or inadequate.
Health Canada said companies will have to provide varying levels of evidence from clinical trials before they’re allowed to make prevention claims on their products for serious diseases.
“It depends on the nature of the claim and what we already know about the product. The more serious the claim, the higher the level of evidence that would be expected,” said Robin Marles, director of the bureau of clinical trials and health sciences at Health Canada’s natural health products directorate.
“There are those who will always be skeptical and perhaps that’s not such a bad thing because in the end that ensures that our industry has the best evidence possible for the products it makes and supplies to Canadians,” Ms. Marrett said.
But most studies on natural health products are funded by companies that have a vested interest in finding a positive result, which means the benefits of many products can be overstated, said David Bailey, a pharmacology professor at the University of Western Ontario who studies interactions between food, drugs and natural health products.
“There isn’t the kind of quality control of documentation at this point in time, so you really don’t know what you’re going to get,” Dr. Bailey said. “I think all of these things [natural health products] should be behind the counter, to tell you the truth.”
Health Canada’s natural health products directorate has also been plagued by a series of problems since it was launched in 2004, which means health officials could be unprepared to handle new applications for prevention claims that are expected under the new rules.
Natural health products are, in theory, supposed to be reviewed by Health Canada before they’re put on sale to determine whether they’re safe and effective. But thousands of unapproved products are currently on the market because of a massive backlog in the approvals process. Health Canada said there are about 12,000 unapproved natural health products awaiting review and it should take two years before it clears out the backlog.
Although health products can be sold before they’ve been reviewed, many companies say Health Canada’s approval is important because without it, they can’t make health claims about their products. The industry is growing increasingly impatient with the lag in approvals and will “work very hard” to ensure products can start carrying prevention claims for serious diseases as soon as possible, according to Ms. Marrett.
Health Canada said it doesn’t expect a flood of new applications and is confident officials will be able to adequately review new product claims. The department also plans to hire eight new enforcement officers to ensure companies don’t sell natural health products that make unapproved claims.
Despite these assurances, many in the medical community say they’re alarmed the government is providing more legitimacy to a booming industry that woos consumers with prevention claims that may not be true.
Dr. Bailey said it’s a problem that all Canadians should know about before putting their trust in vitamins and herbal supplements to have a substantial impact on their health.
“It may create artificial expectations,” he said. “It becomes a buyer-beware phenomenon.”
Canadians purchased $2.5-billion worth of natural health products in 2005, according to the Canadian Health Food Association. But many medical experts continue to question the effectiveness and safety of many vitamins and herbal remedies and whether credible evidence exists to back up product health claims. Here are some examples of products that have been subject to fierce debate:
The claim: Relieves sore throats and cold symptoms
The evidence: Some studies have shown echinacea helps ward off colds, while others say it’s ineffective. A study published in 2005 by The New England Journal of Medicine found the herb has no effect on preventing colds.
St. John’s wort
The claim: Relieves symptoms of depression
The evidence: Research suggests the herb is often effective when it comes to relieving some mild symptoms of depression. However, research has also revealed it can interfere with prescription drugs and make them ineffective.
The claim: Helps relieve pain associated with arthritis
The evidence: Although it’s widely used by Canadians, one major study that looked at the effects of a combination of glucosamine and another supplement, chondroitin, found they were no better than a placebo for reducing pain. The two are often sold together as a treatment for arthritis.
…this post forwarded by Windsor Humanist, Alexander Neil, after a February 4, 2008 article by Carly Weeks in The Globe and Mail.