Strong Medicine

At the Big Carrot Natural Food Market on the Danforth, where the sweet smell of herbs and tinctures fills the air, shoppers have recently been confronted by the sight of black streamers draping the shelves -- a symbolic reminder that Health Canada is moving in a big way into the regulation of natural medicines.This piece of drama -- designed to shock consumers into the realization that some of the remedies they rely on are disappearing forever from health-food counters -- is further evidence of a protracted clash pitting the holistic movement against federal officials who insist their mandate is to protect the public from useless products and fraudulent claims.Last week Ottawa threw down an olive branch and announced the formation of an expert advisory panel to examine the regulation issue.And while election uncertainties and skepticism may thwart this attempt at communion between the Health Protection Branch(HPB) and the alternative medicine constituency, there is a lot to be won and lost.At stake is the shape of the whole future enterprise of natural healing -- the kinds of medicines available, their safety and effectiveness, their pricing-- and whether they all wind up in the hands of the pharmaceutical monopolies.At the heart of the matter is who decides whether a given substance is a drug or a food. Federal officials maintain the public isn't sufficiently informed to make that decision -- and to that end they are currently taking remedies out of the food category and designating them as drugs.Herbal supporters charge that Ottawa regulators are inappropriately applying rules designed for synthetic pharmaceuticals on age-old healing traditions. "At the rate they are going, we could potentially lose up to 90 per cent of herbs,'' says Toronto herbalist Mike Vertolli.According to the Oxford dictionary, a drug is a "medicinal substance, used alone or as ingredient" -- a definition that casts a wide net, given the overlap between food, herbs and synthetic pharmaceuticals, many of which are originally derived from plant sources.Whereas the manufacture and marketing of pharmaceutical drugs has been tightly controlled by government over the years, the use of herbal products has historically fallen somewhere in between lay knowledge and hard science."Natural" products such as cocaine, opium and belladonna have long been restricted because of clear dangers and side effects, including addiction, whereas herbs such as cinnamon, ginger, garlic, cloves and chili pepper -- all entries in the official Chinese pharmacopoeia -- are common table spices, unrestricted in their use even though too much garlic can occasionally cause insomnia and excessive use of chili peppers may in some cases lead to ulcerative colitis.Proponents of natural health products argue that cultural familiarity with these herbs and spices usually leads to prudent usage. While some, such as nutmeg, can be toxic and even mildly hallucinogenic, they are normally only used in small amounts, and most cooks would be outraged if their supplies of nutmeg for Christmas and Thanksgiving were suddenly regulated.The herbalists' assertion that Ottawa has recently been on a "herb-banning" rampage is one that's vexingly difficult to track down. Health Canada's current drug status manual, which lists the legal standing of therapeutic products, is four years old. "The 1993 one is the latest," admits the HPB's Micheline Ho. "We're working on revising it, but it's not ready yet."Without that, it is next to impossible to be sure just how many natural health products have been declared "new drugs" and how many of these will meet the exacting requirements that will allow them to remain on store shelves.For one thing, Health Canada is now demanding that herbs classified as new drugs have a Drug Identification Number (DIN), a signifier that the product is both safe and effective, i.e., it does what it says it does. To get this, the remedy must have undergone scientific testing either in Canada or elsewhere in the world.For pharmaceutical drugs, that's what should be done, says the Canadian Coalition for Health Freedom's Robert McMaster, but the same rules shouldn't apply to natural remedies. "(Health Canada's) yardstick for a drug is randomized, double-blind placebo-controlled trials. It's a very lengthy, expensive and complicated process. It takes millions to get a drug approved in Canada."McMaster -- who also is employed as science director for Nu-Life Vitamins -- argues that the requirement for clinical proof of efficacy effectively bars natural remedies such as herbs and tinctures, most of which can't be patented, unlike pharmaceutical drugs, "So no one is ever going to do these trials and investigations."The traditional way around the requirement for lengthy trials, of course, is simply to avoid making claims on behalf of any given product, simply making it available as is, without any reference to supposed therapeutic benefits.But health food enthusiasts worry that even third-party anecdotes -- like articles published in health-food magazines -- are sufficient cause for authorities in Ottawa to clamp down on various substances, even if the manufacturer and distributors don't make any claims themselves.Ho at Health Canada says this isn't the case. Her department, she says, only takes action if the manufacturer or retailers themselves make specific claims regarding a product. "If somebody simply sells garlic at the grocery store, it's not a drug. But if you put it in a capsule and then put it in a bottle with a label on it that says it will treat a condition, then you are representing it as a medicine.''Many herbalists insist their products don't warrant such attention because they are basically "low-risk'' -- often botanicals such as those used by Chinese herbalists, which, they say, have worked their medicinal magic in other countries for hundreds of years."We say to (Health Canada) that these things have been used in other jurisdictions for extremely long periods of time by large numbers of people, so if there were adverse effects, show us the bodies,'' says McMaster.But Ho maintains that while most herbs that cause acute adverse reactions in the short term are well known, those that are dangerous with chronic use are not."It's not enough to say a herb has been used in China for hundreds of years. Maybe it's true, maybe it's not. If that use has not been documented, how do we know it hasn't caused problems?"Another point of contention for herbal supporters is a series of new licensing fees on manufacturers, importers and distributors of natural health products.Andy Butterfield at Health Canada says that in the past there were virtually no fees passed on to the drug industry for Health Canada services. The new fees came about in 1994, in the wake of cutbacks to Health Canada's appropriations.The fee to get a DIN for the first time for a product runs between $250 and $200,000, with new drugs that require clinical trials at the upper end of the scale. Most herbal products, unless they are "new drugs," are charged a fee of $720. But for a $1,000 fee, businesses that are not expecting to sell a lot of a product can get the fee reduced to 10 per cent of expected sales of the drug for the first three years.And starting this summer, Health Canada will be requiring all facilities that produce or import natural health products to pay an "establishment licensing fee." That can run from $1,000 to $50,000 or more, depending on the number of products handled.Again, there is a fee reduction option, with the licensing fee not to exceed 1.5 per cent of the company's drug sales.Butterfield says the lower rate exemptions for the three fees were added precisely to protect smaller businesses.But herbal producers say Health Canada's concessions are not as helpful as they might seem. Joel Thuna, manager of Global Botanical in Barrie, says many of the ingredients he uses to make his 3,000 herbal remedies come from other suppliers, who may also get some of their herbs from yet other suppliers. "Each one has to go through cost recovery, each one has to pay 1.5 per cent, and it all adds up," says Thuna.He has calculated that after all the fees have gone into effect, consumers are likely to see the prices rise between 20 and 50 per cent.Herbal manufacturers also argue that the feds have recently been even more demanding, with their insistence on an exacting set of standards known as "good manufacturing practices."Many observers argue that, while it is entirely appropriate to demand these standards of pharmaceutical drug makers, Health Canada inspectors end up looking for the wrong things when they try to apply them to small herbal facilities."Adapting the drug model to herbs is putting a square peg in a round hole," says Thuna, whose family has been producing botanicals since the 1860s. He says when his Barrie facility was inspected in March, the inspector didn't seem to know the first thing about how herbs are made."He wanted to know when we purchased a herb, who harvested it, who picked it, who dried it, how it was dried and on and on," says Thuna. "Well, many of my extracts come from people searching for these herbs in South America and Africa, and many don't speak English.''Thuna says the inspector seemed particularly concerned about the making of herbal tinctures like echinacea. Global Botanical uses distilled water from a major Ontario bottler, but the inspector wanted a complete breakdown of every step in the distillation process. Thuna says that, based on what he saw, he expects to hear that his facility did not meet "good manufacturing practices."McMaster insists that his organization is just as concerned about the possible dangers associated with products of uncertain origin or purity. "We would not be tolerant of anything that would place the safety of the public as consumers in jeopardy," says McMaster."But if a public inspection is going to be made," he urges, "send someone who knows something about the process.''At the HPB, Ho denies her department inspects natural products the same way they inspect synthetic pharmaceutical preparations. "For herbal remedies," she points out, "we are using the World Health Organization standards on herbs, which focus on identifying herbs properly throughout the whole manufacturing process, from harvesting to the manufacturing plant. You have to make sure there hasn't been any mix-up of shipments.''One question many are asking themselves about Health Canada's latest moves is, why now? Meera Thadani, at the University of Manitoba's faculty of pharmacy and an expert on natural health products, says this debate has arisen now because of the growing popularity of herbal remedies."Health Canada had to respond to this," she says. With all this rising popularity, Ottawa feels pressure from pharmacists and doctors, who are unsure what to tell patients about adverse effects, and from consumers concerned that a herbal remedy really is what it says on the bottle.But some think there may be more to it. NDP MP Svend Robinson, who tabled a motion in the House in early April calling for a moratorium on any more restrictions on natural remedies, suspects that the big pharmaceutical firms pressured the Liberals on this issue, just as they did on the drug patent legislation."Let's face it, natural health products have the potential to become a lucrative market. And I assume the pharmaceutical industry is keen to get in on that market,'' he says.It's a charge that mystifies Christiane Menard of the Pharmaceutical Manufacturers Association of Canada, which represents 68 drug companies. "It has nothing to do with us," insists Menard, who says the association is not lobbying on this issue. "Absolutely not."But at the HPB, Ho lets it be known that the drug firms have long wanted manufacturers of natural health products to pay their fair share of licensing fees. "The rest of the industry expects a level playing field, just like the herbal industry expects a level playing field."Whatever fuelled Health Canada's new initiatives, it's clear they are under some competing pressures, signalled by their announcement last week of the formation of an expert advisor panel.But alternative health boosters are skeptical. McMaster believes this latest initiative is a predictable election ploy. "There have twice been 'expert advisory committees' on herbs, and every time they met, they made a nice report, and then they did nothing,'' he says.Still, he is cautiously hopeful that this new panel will have a very broad mandate and will include qualified people from the natural health products industry.Although they are all in agreement that change is needed, the handful of natural health activist organizations are deeply divided over just what kind of changes they'd like to see at Health Canada.And looking to other nations for clues as to how best to regulate this growing industry opens up a mixed bag. In Britain, most natural health products are classified as food supplements and are not regulated by the government.In Germany, herbal remedies have been classified as part of the Commission E Monographs, a government-sponsored review of therapeutic herbs. The commission has reviewed 300 herbs and has approved about two-thirds of them as safe and effective, many of them prescribed and paid for under government health plans.South of the border, as in the UK, natural health products are defined as "nutritional supplements" and do not face the same kind of regulation as drugs. "Basically, the products can be marketed without FDA review or registration," says Arthur Whitmore, a spokesperson for the U.S. Food and Drug Administration (FDA).In that unregulated climate, there have been wide variations between what botanical makers say their bottles contain and what is actually inside.Indeed, though most in the Canadian natural health industry may disagree with the process the feds use to ensure safety, few advocate the Americans' Wild West attitude toward their herbal products. "The lack of regulation there is a nightmare," says Thuna.Valerie Dugale of the Canadian Natural Health Product Association agrees. "We do believe these products should be regulated, that what is on the label is what is in the bottle."Dugale also argues that one down- side of not being regulated is that manufacturers can't tell consumers what their product treats. "More and more suppliers want to be able to say what the product does -- and to be able to list contraindications.''The CCHF, with the support of many groups in the food supplements industry, wants to avoid the drug/food classification problem and is advocating the creation of a third category -- natural health products -- to be administered by a body independent of Health Canada composed of botanical industry reps and government appointees.Instead of having to pay for DINs, natural health products would have lower fees for their registry numbers reflective of the fact that, unlike drugs, they cannot be patented and so are not as profitable.Not all alternative health boosters support that idea, however. Holistic physician Zolton Rona, who runs a rival group, the National Coalition for Health Freedom, argues that the CCHF's solution would be costly. "I think that's just going to create a new level of bureaucracy," he says.Rona suspects that the CCHF is working on behalf of Canada's large vitamin makers -- companies like Swiss Herbal Remedies and Nu-Life Vitamins, which employs coalition member McMaster, as Rona is quick to point out. "The only people who'd be able to afford the independent review body would be the major companies," he says.Rona proposes that herbs be classified by Health Canada as foods, and that worries over safety should be dealt with in the same way as fears over the safety of vegetables -- by Agriculture Canada. He further argues that consumer concerns over accurate labelling can be handled by our current laws."This has never been a problem in Canada. People have the right to report these things to appropriate agencies. We have good anti-fraud laws.''The NDP's Robinson isn't taking any particular position on how herbs and other natural remedies should be regulated. "I'm just saying 'Back off' to the Liberal government. 'Impose a moratorium until there's been an opportunity to hear all the arguments.' In fact, I wish they'd spend spend more time and attention on some of the potential abuses of legal pharmaceutical drugs in this country.''Research assistance by Colin Leslie