Regulating Natural Remedies: For People or Profit?

Nicholas Culpeper, a 17th-century apothecary with a love for healing with herbs, caused an uproar when he translated the London Pharmacopoeia of the College of Physicians from Latin into English, adding practical advice to help ordinary folks take charge of their own health. The College of Physicians protested. They had been keeping their knowledge a secret and the costs of their treatments too high.

"I would they consider what infinite number of poor creatures perish daily who else might be happily preserved if they knew what the herbs in their own gardens were good for," Culpeper said.

Four centuries later, modern-day consumers and producers of Canadian natural health products have fears comparable to those of 17th-century Brits. When Health Canada's natural health product regulations are phased in during the next several years, will natural remedies become less available? Will they be too expensive for regular folk?

That's what everybody wants to know.

"I predict that there will be a moderate price increase," says David Chapman, president of Purity Life, a natural product manufacturer and distributor. The regulations include strict requirements for good manufacturing practices, which would ensure products of consistent quality but may also make the cost of manufacturing more expensive perhaps too expensive for smaller companies to remain in the market.

Kahlee Keane, an eco-herbalist in Saskatchewan, says it would be good to know that natural remedies are quality controlled if the government can be trusted to do its job.

"There is a lot of adulteration going on...there are brokers I know who would not be able to tell an echinacea root from a dandelion root," she says.

The Natural Health Products Directorate (or NHPD formerly the Office of Natural Health Products) will be responsible for as many as 30,000 products. The NHPD says it will ensure not only that their quality is consistent, but also that they live up to claims made on the labels. New labels would help consumers make more informed decisions by indicating what the product does, how much is needed and what to avoid when taking it.

Some feel the industry is better off being responsible for its own regulations. Mike Nacachian, owner of Naka, a manufacturing company, says the industry can be educated on quality control without government intervention. Like Chapman, he believes that new regulations may force price increases, as well as make it harder for new companies to start up because of regulatory hurdles.

"I'm very concerned that regulation will just mean increased costs, delays for new products and more tax expenses for consumers," he says.

Philip Waddington, naturopathic physician and director general of the NHPD, says, "We believe strongly that the proposed regulations will increase access to natural health products, remove some of the barriers that are currently in place and allow consumers to purchase products that have been produced in a cost effective and responsible manner."

He says the manufacturing guidelines, developed in close consultation with natural health industry and consumer groups, "will ensure sound manufacturing and quality assurance practices, while not setting the regulatory bar so high as to impose unreasonable cost burdens on manufacturers, importers and distributors of natural health products."

He also says that natural health products will be more quickly and easily available because the regulatory framework under development will allow differences to be recognized between traditional remedies with a long history of safe use, products known as beneficial by the health and scientific communities, and products used to treat serious conditions.

Echinacea, for example, can back the claim that it relieves the symptoms of colds and flu with evidence from traditional references. Vitamins and minerals can be backed up by literature reviews. Products to treat life-threatening conditions will require clinical trials. Current regulations classify all natural health products as either foods or drugs, with those classified as drugs getting mired in the approval process.

Rick DeSylva, owner of the Herb Works in Guelph, Ont. and active participant in the consultations with the NHPD, isn't convinced that the government is providing full disclosure of its intentions. "We're still being hosed," he says. "We've been told we're not allowed to make a claim unless they allow it." (See his article, "New Vision or Old Aversion?" in alive #232.)

Anne Ledger Wilkie, director of science at the Canadian Health Food Association (CHFA) says that as currently drafted, the regulations still won't allow the sale of all products that consumers want. Specifically, the CHFA is working to revise or eliminate Schedule A of the Food and Drug Act, which prohibits product advertising claims and is still in place in the new regulations. Schedule F of the Food and Drug Act, which lists products such as carnitine and tryptophan as prescription drugs, is also still in place.

"This schedule must be revised in light of the new regulations to ensure the availability of the products to consumers," she says.

At the time of printing, the formal 90-day consultation period (phase two of the regulatory process) will have just ended. The next step is for the new regulations to be made into law under the Food and Drugs Act.

If established with the best interests of the natural health industry and consumers in mind, the regulations could make Canada a pioneer the first country in the world to successfully integrate natural remedies into mainstream health care. But if, as so many fear, the government bows to corporate interests, it could end up being like the College of Physicians of yore, making natural health a luxury only the rich can afford.

The solution may ultimately lie in the hands of the people. As in Culpeper's day, education is critical especially because our health-care system is crumbling, privatization is looming and there's a real possibility that many more Canadians will not be able to afford decent health care.
Kahlee Keane says, "I believe that all people should know the plants intimately and learn to find and make their own medicine, so in that way it is always available as Mother Earth intended."

Culpeper would have been proud.

For more information on the pending natural health regulations, visit hc-sc.gc.ca/hpb/onhp or phone Health Canada at 613-957-2991.