Better enforcement of Natural Health Products needed

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Alternative medicine and especially Natural Health Products (NHPs) are growing in use, but when people visit hospitals and ask about such things, most health care practitioners they encounter have little knowledge in this area. That’s not surprising because these professionals are trained in Western medicine.

The NHP Products Regulations came into effect in 2004 and define the category as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, as well as probiotics, and other products like amino acids and essential fatty acids. Why is this important? According to a 2010 Ipsos-Reid survey, 73 per cent of Canadians regularly take vitamins and minerals, herbal products, and homeopathic medicine.

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The role of the NHP Directorate – it’s part of the Health Products and Food Branch of Health Canada – is to ensure that we have ready access to NHPs that are safe, effective and of high quality. But NHPs are over-the-counter products and don’t require prescriptions, and keeping tabs on their sale and distribution isn’t easy.

Consider the retailer who faced repeated Health Canada recalls because of selling products found to contain hidden ingredients and unauthorized substances similar to the prescription drugs sildenafil and tadalafil. There was nothing on the product labels or packaging to indicate such ingredients.

Another retailer who manufactures and distributes NHPs also got a recall order, but refused to comply, despite the fact that one of its nutritional shakes contained the prescription drug chloramphenicol. Health Canada says this is an antibiotic associated with the risk of a potentially fatal blood disorder.

The retailer said contamination wasn’t a health risk because of low concentration in its shakes. Nevertheless, an NHP product for sale containing a known pharmaceutical is against the law. Enforcing the law is something else again.

Health Canada has a major challenge because of a lack of resources. While most players involved in the NHP industry are ethical, there are unscrupulous retailers, manufacturers and distributors who are less than honest with the consumer. The industry is not subjected to audits, and even when problems arise, the process in dealing with them is bureaucratic and time-consuming. Also, it’s easy to get around loopholes.

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For example, a U.S. company shipping product to Canada must deal with added levels of security at the border, but if the company establishes a manufacturing facility in Canada, the same level of security no longer exists. The company can make what it wants and sell it, even if the information on the label or packaging is less than accurate.

Health Canada reacts when a complaint is lodged, but there is very little that is proactive in the process. Even though the NHP world is regulated, the rules are not enforced, giving an unfair advantage to unscrupulous players who can make any claims about their products.

The federal government recently announced new legislation called The Protecting Canadians from Unsafe Drugs Act. The Act, which could become law this year, applies to prescription and over-the-counter drugs, as well as medical devices, vaccines, gene therapies, cells, tissues and organs. The Act:

  • Imposes stiff penalties for unsafe products with fines up to $5 million a day and two years in prison for those who do not comply with orders;
  • Speeds up product recalls or label changes when a problem is identified; and,
  • Increases patient safety by improving Health Canada’s ability to collect safety information on products sold for      therapeutic use.

While this legislation does not specifically address NHPs, it would deal with those who defy a Health Canada order to recall product found to contain a prescription drug, or a product similar to a prescription drug. Thus, a business that defies a Health Canada recall could face severe penalties.

A University of Guelph study published in the journal BMC Medicine should serve as a wake-up call about the potential dangers of some NHPs. The study used DNA barcoding technology to test 44 herbal products sold by 12 manufacturers, and showed that most of the NHPs surveyed contained fillers and plant ingredients not listed on the label. One ginkgo product was contaminated with Juglans nigra (black walnut), which can be fatal for anyone with a nut allergy. Almost 60 per cent of the herbal products contained plant species not listed on the label, and more than 20 per cent included such fillers as rice, soybeans and wheat which, again, were not on the label.

There is virtually no enforcement of quality control for the manufacture and labelling of Natural Health Products in Canada, and while the University of Guelph study concluded that we need more regulations, in fact, we don’t. But existing regulations should be better enforced. People who suffer from plant allergies or seek gluten-free products should not to be exposed to these hazards because they buy NHP products that are improperly labelled.