Poor Controls on Natural Health Products Raise Concerns
For practically anything that might ail you, there's a so-called "natural health product" for sale that promises to help. Echinacea is supposed to combat colds, and glucosamine is said to limber up arthritic knees. St. John's wort is touted for relieving restlessness. Rosemary, more than just a good partner for olive oil in a marinade, is credited with improving mental clarity. And frankincense, which many associate only with Christmas pageants, is marketed as good for "nervous problems."
This is not a random sampling of folk wisdom, or at least not only that. All these claims, and hundreds more like them, are now approved by the federal government for use on labels and in advertising. Since 2004, a branch of Health Canada called the Natural Health Products Directorate has been slowly rolling out regulations for the multi-billion-dollar industry that occupies the hazy zone between drug science and healing lore. Products ranging from amino acids to fungus to animal materials have already come under the NHPD's regulatory framework. As of June 1, its rules start applying to a huge, important category of previously unregulated products that includes plants and products derived from plants.
The argument for such oversight is compelling. One study found that 75 per cent of Canadians at one time or another buy natural health products, ranging from mild teas to potent herbs. But if most experts agree that regulation makes sense, critics raise troubling questions about whether the system Ottawa has put in place is going to do the job. They argue the NHPD is, in some cases, putting a federal seal of approval on products that science shows don't work. Some researchers fear that health risks are not being taken seriously enough. And, in the wake of the recent pet food scandal, in which contaminated ingredients came from China, the offshore sourcing of many natural products - including commonplace vitamins - is coming under intense scrutiny.
Among those raising the alarm is David Bailey, a professor of clinical pharmacology at the University of Western Ontario. Bailey is known for his discovery that grapefruit juice can interfere dangerously with drugs ranging from blood-pressure medicine to Prozac. His research into drug interactions has him worried about little-understood natural products. "In many cases we have no data on efficacy, no data on safety, no significant regulation in terms of availability," he says. "There's a huge misperception that because they come from a natural source they are safer and they are gentler."
What bothers Bailey most is that the onus is on those, like him, who are urging caution, to expose the dangers, and not on the companies that sell the products to establish that they are safe and effective. "Once these things are on the market - and this is what really astounds me and most people find hard to believe - you actually have to prove that there's a problem," Bailey said. "The manufacturer doesn't have to prove that the herbal is safe or that it does anything."
Indeed, the regulations that came into force in 2004 were never designed to extend the standards that apply to pharmaceutical makers to the natural products industry. Putting the estimated 40,000 natural products on the market through scientific trials wasn't a real possibility. Instead, the Liberal government of the day aimed to bring some order to the marketplace, while emphasizing acceptance of traditional claims. Products would be licensed on the basis of long-established uses, often grounded only on folklore, but buttressed by clinical evidence where it existed.
About 13,000 natural products are now licensed, well under half of the total thought to be for sale. Keeping up is a challenge: in the run-up to the June 1 deadline for plant-based products, the NHPD was coping with about 40 product-licence applications a day. According to the timetable set for it at the outset, the NHPD hopes to bring the entire sprawling industry, ranging from tiny family firms to heavily advertised brands, under regulation by 2010. But at this point, many unlicensed products still share shelf space with the growing number that carry a new eight-digit licence number - look for it after the letters "NPN" on the label - which certifies Health Canada has reviewed it for safety, quality and what it's supposed to do.
But does that number really offer much assurance to the consumer? One thing it doesn't signify is that science necessarily supports any claims found elsewhere on the packaging. The NHPD produces summaries, which it calls monographs, on the traditions surrounding many substances, along with any supportive science. Companies are encouraged to refer to these monographs when applying for product licences. "A lot of the focus of the monographs is on the traditional-use claims," says Heather Boon, a pharmacy professor at the University of Toronto who serves on the NHPD's expert advisory committee. "It's not a completely exhaustive review of the scientific evidence."
In fact, critics say the monographs often don't reflect up-to-date science. Take the various forms of the echinacea plant that have long been considered useful for fighting off the common cold. The NHPD lets manufacturers rely on both that tradition and certain clinical studies that appear to back it up. But some leading medical experts say state-of-the-art research strongly suggests echinacea just doesn't work. Dr. Stephen Straus, the late director of the U.S. government's National Center for Complementary and Alternative Medicine, said categorically in 2005, "We've got to stop attributing any efficacy to echinacea."
One of the studies that led Straus to make that statement was a trial that year led by Dr. Ronald Turner of the University of Virginia's medical school. Turner's team gave 399 healthy volunteers either one of three echinacea extracts or a placebo, then exposed them to the cold virus. The study found those who got the echinacea were just as likely to catch a cold as those who didn't, and symptoms were about the same in both groups. Turner agreed to briefly look over the NHPD echinacea monograph for Maclean's, and said there is "a substantial body of evidence suggesting that echinacea is ineffective for colds" that it fails to include.
Glucosamine, made from shellfish exoskeletons, is another big seller under a shadow of doubt. The NHPD allows manufacturers to say glucosamine "helps to relieve joint pain associated with osteoarthritis" and "protects against the deterioration of cartilage." But the Arthritis Society of Canada advises that while some older studies suggested glucosamine might ease pain and improve joint function, "newer and more high quality studies" show that pain doesn't lessen and physical ability "may not improve at all or as much." Dr. Arthur Bookman, a leading Toronto arthritis expert, draws this conclusion: "Glucosamine would not qualify as a substance being offered by the PHARMACEUTICAL INDUSTRY, and the claims of benefit being offered by the natural food industry can be no better supported."
Yet Health Canada does support those claims, and doesn't seem inclined to back away from them. Boon said those raising the objections tend to be dazzled by the latest research. "It's the totality of evidence that we're looking for," she said. "It's not like the newest trial is the answer." NHPD director general Phil Waddington said the real questions can't often be answered by one big study. "It's usually not, 'Does echinacea work?' The question is, 'Does it lessen the symptoms of colds and flus? Does it lessen the duration? Does it lessen the likelihood of a secondary infection?' " he said. "It's not a yes-or-no question."
Still, he said if new science clearly eclipsed old studies that supported a traditional product, the NHPD would cease to allow the manufacturers to make any discredited claims. But its work to date vetting thousands of products suggests the NHPD sets a very high bar for research trumping tradition. "At this point, we have not yet prevented a traditional claim," Waddington said, "but we are looking at this all the time."
The NHPD has been quicker to impose restrictions where safety is the issue. For instance, it banned combinations of derivatives of the herb ephedra, known as ephedrine, with stimulants like caffeine, after research showed risks ranging from heart-rate irregularities to seizures. But critics say action is not always so decisive. UWO's Bailey points to the problems associated with St. John's wort. The herb, sometimes used to treat depression or sleep disorders, can seriously lessen or alter the effectiveness of drugs prescribed for the same conditions. But Bailey said most brands for sale in Canada don't note that risk on their labels. Waddington said the drug-interaction warning will be required as St. John's wort products come under the licensing regulations. For Bailey, however, that isn't enough. "At the very least," he said, "anybody who wants St. John's wort should have to talk to the pharmacist."
It's remarkable so many serious questions arise about even the most familiar natural health products. Much less is known about many others, including traditional Chinese medicines. Jeff Poston, executive director of the Canadian Pharmacists Association, said glucosamine's history suggests a pattern: a product gains acceptance, small clinical trials look promising, but then more researchers take note and run bigger studies, which fail to find the same benefits. "We can see that as a path that we're probably going to follow with a number of natural health products," Poston predicted.
While substances are studied and debated, consumers will at least expect Health Canada to keep them safe. A key element in that mission has to be ensuring that products come from reasonably well-run facilities, both in Canada and abroad. The NHPD's site-licensing rules require companies to file paperwork confirming that they meet "good manufacturing process" standards. About 600 sites in Canada where products are manufactured, packaged, labelled and imported are now licensed. Companies must also vouch for the foreign plants where they source their products.
But enforcement is hardly hands-on. A Health Canada official said the department is "still in the early stages of exploring" the possibility of inspecting Canadian sites. As for foreign suppliers, the official said there were "no international agreements in place" for co-operation with health authorities in countries like China, where many natural products sold here originate. After the pet food contamination uproar, concern is spreading in the U.S., where natural health products are not regulated, about vitamins coming from China. Peter Kovacs, former president of NutraSweet Kelco, warned in the Washington Post that 80 per cent of the world's vitamin C comes from China, "much of it unregulated and some of it of questionable quality."
Meanwhile, two big U.S. food companies, Mission Foods and Tyson Foods, are reportedly trying to wean themselves off Chinese ingredients, including vitamins. And Europe narrowly averted disaster earlier this spring when vitamin A from China was discovered to be tainted with harmful bacteria before it was added to infant formula. While these concerns focus on loose vitamins meant as food additives, it seems only a matter of time before attention spreads to the standards for those packaged as dietary supplements for consumers.
Still, Waddington said the NHPD site licensing rules give him confidence offshore sources are clean, and that Canadian importers are properly tracking their ingredients through distant supply chains. "What they are providing us with is the paperwork," he said, "behind the processes that are in place."
That may not give cautious consumers much comfort. Neither will the results of a 2006 study by a team of University of Toronto researchers, including Boon, of attitudes inside the natural products industry toward the regulations. Among large companies, they found, "many suggested little enforcement action is occurring." One company official was quoted saying federal agencies "don't have the resources to be policing this, so the reality is they are going to rely on people snitching, and the industry has not typically snitched on each other."
Defenders of the NHPD say consumers are still far ahead of where they were when there were no rules at all. "I look at it as a before-and-after picture," Boon said. "Before, these products were already on the market, and we had no quality control and no manufacturing standards in place." To what degree Canadians can really count on those controls and standards now, however, clearly remains as debatable as the claims on the bottles bearing the new federal licence numbers.
Maclean's June 4, 2007