Regulating Natural Health Products


Barely a week goes by without some mention in the news of alternative medicine. In fact, for some, alternative medicine is not really that alternative anymore. But until 1999, the Canadian government gave alternative medicine a wide berth in terms of regulations. All that is changing, however, because the recently established Natural Health Products Directorate (NHPD), which is housed within the new Office of Natural Health Products (ONHP), aims to not only fully explore how natural health products work and monitor manufacturing practices, but also to encourage a new wave of research in the area.

Over the years, the tide of immigration in Canada has brought exposure to new therapeutic knowledge and medicinal practices from other countries and societies. According to government sources, over 50% of Canadians now consume natural health products (NHPs) in the form of traditional herbal products, vitamins and mineral supplements, traditional Chinese medications, and other medicines and homeopathic preparations. Interest is also increasing in aboriginal medicine, which has remained largely uninvestigated and practiced only by native communities.

But a large portion of the general public--as well as many health practitioners--remain sceptical about the benefits of products that have not been scientifically proven. Moreover, the multitude of herbal and other remedies that have crammed the shelves of drug stores and NHP outlets were not marketed with government approval. Nor was their quality ensured. Natural health products have traditionally lurked in murky regulatory waters, somewhere between a drug (when the manufacturer claims that it improves health) and a food (when no health claims are made).

As a solution to this quagmire, Health Canada allocated CA$7 million over 3 years to create ONHP, a new regulatory authority that is charged with providing some legitimacy to alternative medicine through pre-market assessment, enhancing consumer access and choice to a full range of natural health products, and ensuring consumer safety. The office, more commonly referred to as the Natural Health Product Directorate, was the government?s response to the Standing Committee on Health Report in 1999, "Natural Health Products: A New Vision."

The first NHP regulations come into force early next year and will affect between 30,000 to 50,000 products. All NHP products on the market will be required to submit information on full exploration of the substance, how it works, evidence for the compound?s efficacy, and what are the conditions of use in order to gain a NHPD license. Additionally, the manufacturers will be required to demonstrate Good Manufacturing Practices compliancy.

NHPD currently employs about 40 people in the areas of policy and regulatory affairs, product review and assessment, research, and outreach and education. Their backgrounds range from biology, chemistry, pharmacy, toxicology, law, regulatory affairs, naturopathy, and medicine. Heather Throop, director of policy and regulatory affairs, says that the office is expected to hire an additional 60 employees within the next 6 to 8 months. ?The major growth [in employment opportunities] is going to be in the Bureau of Product Review and Assessment," says Throop. ?There is much work to be done on the product submission process including review of the physiological properties, potency and purity of substances, as well as in monograph development, standards of evidence, chemistry and manufacturing, and clinical trial development." She expects that notifications of job openings will appear on the NHPD Web site in the coming months.

In addition to regulating products, the government is contributing CA$3 million over 3 years in research funding on natural health products and complementary medicines. ?We will be supporting academic community research efforts, as well as partnering with granting agencies such as the Canadian Institutes of Health Research [CIHR]," says Throop. It is anticipated that the first CA$1 million instalment of the grants program will become available next April. Administration of the research funding would be divided equally between CIHR and the Bureau of Research at NHPD. Throop concedes that $1 million is not a significant amount for research, but adds, ?What we are trying to do is get a research network going across Canada and trying to use that network as leverage for more research funding."

Critics of the government?s new office argue that the risks posed by natural health products are minimal and do not warrant the expenditure on a new regulatory body. Some, according to Throop, are also concerned that regulation of NHPs will drive up costs and limit access. Despite the opposition, she says the government?s intervention will assist from a health and safety perspective, forcing industry to improve its standards. The new regulations do not seem to be meeting with opposition from the latter, says Throop: ?Industry thinks the new regulations will go a long way to improving consumer confidence about what they are buying."

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