Consumers can expect to pay more for natural health products in the coming years. But at least they’ll know what they’re getting. New Health Canada regulations will affect everything from manufacturing and distributing to licensing and labelling.
Under the federal Natural Health Products Regulations (NHPR), all manufacturers, importers, packagers, and labellers were required, effective January 2006, to “employ good manufacturing practices (GMPs) and have site licences.” In addition, by 2010, all natural health products must be labelled with an eight-digit natural products number or drug information number-homeopathic medicine, preceded by the letters NPN or DIN-HM.
Before 2004 when the NHPR came into effect, natural health products were classified as drugs, which required rigid testing standards, or as foods, which limited the health claims producers and suppliers could make about them. The new regulations are designed to assure consumers that products sold over the counter are safe and effective.
Recent information sessions held by the Natural Health Products Directorate (NHPD) in Toronto, Montreal, Saskatoon, and Burnaby helped representatives from industry, local government, and consumer groups navigate the new regulations. About 600 people a day attended each of the two-day sessions, with around 150 a day at the sessions in Burnaby. This is the fourth time the NHPD has conducted sessions since the regulations came into effect.
How Will Regulations Affect Cost?
Several people attending the information sessions in Burnaby said the regulations will lead to cost increases. “Yes, very much so,” said Calvin Louie, vice president of Vancouver-based Le Kiu Importing Co. Ltd., in an interview with alive during a break in the sessions. “Now I have to do more testing, especially identity testing. There will be an increased cost for the consumer, but hopefully we’ll keep that percentage down; it won’t be that high a cost.”
Health Canada’s website also admits that costs may rise: “Depending on the current quality of the manufacturing practices used by each company, and the safety and efficacy information they have gathered in formulating their products, a short-term cost increase may be anticipated.”
The website notes, however, that costs would be even higher if natural health products were classified under drug regulations, and it adds that consumers have “indicated a willingness to pay more, provided that the products are of high quality; the government has approved a product licence; and there will be improved labelling.” Increased consumer confidence may also lead to increased demand and an eventual cost decrease, according to Health Canada.
Louie, whose company has been importing natural health products from Asia Pacific since 1946, thinks the costs will be higher for the foreseeable future. “I think it will be ongoing,” he said, “because there’s going to be ongoing testing.” He added, though, that a slight decrease could come about as the testing labs get higher volumes of business, allowing them to bring their costs down.
Are Regulations Applied Consistently?
During question-and-answer periods at the end of individual presentations, industry representatives raised a variety of concerns about the process. Many complained of the backlog and others just needed clarification of the complex rules.
A representative from Coquitlam-based Natural Factors Nutritional Products Ltd. said that his company, with more than 600 applications, had been finding the process inconsistent, with some product registrations being stalled by requests from the directorate for more information, while other products were being approved, even though the information provided was similar.
“The worst-case scenario is that your product is seized and you can’t sell it,” Louie said, noting that products can be seized or stalled for any number of reasons.
Regarding the backlog, Health Canada media relations officer Ren?France Bergeron told alive in an email, “Since the implementation of our Business Improvement Initiative in 2005, the NHPD has significantly strengthened its review capacity and made significant progress in eliminating the backlog of product licence applications,” and that there is no longer a backlog for site-licence applications.
Bergeron said the backlog for product licences was supposed to be cleared up by March 2007 but that has now been extended to March 2008 due to “delays in the development of an online system for the processing and assessment of incoming applications.”
It’s About Customer Safety
Overall, however, the new regulations seem to be meeting with approval from consumers and people in the industry. “The whole idea is to protect the consumer, and we’re all for that,” Louie said. He added that it does take more effort on the part of suppliers and importers, especially because many are dealing with overseas manufacturers where standards may be different. (Even overseas manufacturers require site licences for products to be sold in Canada.)
Besides the registration numbers, product labels must include information to let consumers know exactly what is in the product, what it is to be used for, and that the products have been subjected to strict testing, along with other information regarding dosage, storage, and risks.
Depending on the type of product, testing requirements for safety and efficacy vary. For example, products that use animal tissue, especially where there is a concern about bovine spongiform encephalitis (BSE), or mad-cow disease, may require more rigid testing than some plant-based products. The NHPD recognizes five different types of evidence for a product’s efficacy, ranging from controlled trials (level 1) to “references to a traditional use” (level 5).
With homeopathic medicines and traditional Chinese medicines, the emphasis seems to be more on safety than how effective a product is. Homeopathic medicines, for example, require a lower level of evidence of efficacy than some other products, according to Katherine vanDyk, an assessment officer in the homeopathic unit of the NHPD.
During an information session on homeopathic products, vanDyk noted that Health Canada only requires lower-level 4 or 5 testing, even though it encourages level 1 to 3 testing (the highest standards), because “in homeopathic medicine, it is still uncommon to see those [higher] levels of evidence.” Level 4 evidence only requires that the products be included in things such as “peer-reviewed published articles” or “homeopathic pharmacopoeias.”
Now, It’s Up to You
The NHPD states that its “role is to ensure that Canadians have ready access to natural health products that are safe, effective, and of high quality while respecting freedom of choice and philosophical and cultural diversity.” Most people agree that it is succeeding, even if it is taking some time. It’s still up to consumers to make sure they read the more detailed labels on the products.