Cracks found in Health Canada oversight of vitamins, probiotics

Natural health products like vitamin supplements are used widely by Canadians, but a lack of oversight from Health Canada has failed to guarantee the safety and efficacy of these products, a new report reveals.

“Over 70 per cent of Canadians use natural health products, so this is something that affects their consumer choices, their daily lives and, ultimately, their health,” said Environment and Sustainable Development commissioner Jerry DeMarco, who tabled the report on Thursday.

The bottom line is: Health Canada should be doing a much better job of overseeing the natural health products industry, he said.

Natural health products include things like vitamins, mineral supplements, probiotics, homeopathic medicines, traditional medicines, alcohol-based hand sanitizers, and products making health claims about managing weight or sleep.

The report found Health Canada approved natural health products based on evidence of safety and effectiveness, but its inspections of manufacturing facilities were limited. Often, the department relied on the manufacturer’s claims of good practices, according to the report.

Technically, natural health product licence-holders are required to tell Health Canada which facilities manufactured the product before selling it, but this was not enforced by the department and less than five per cent of all active product licence-holders complied, according to the report.

Inspections are essential to ensure products contain the right doses of medicinal ingredients, don’t have chemical or microbial contamination, are effective until their expiry date, and are processed at facilities with good sanitation practices. People can have adverse reactions from products that fail to meet these requirements.

The report listed septic shock, jaundice, and disruption of liver function as just a few documented adverse reactions to natural health products.

Another issue the report flagged is misinformation.

“Once natural health products were on the market, Health Canada’s monitoring was insufficient to ensure that products were as described on the label, or licensed for sale,” said DeMarco.

In fact, 88 per cent of the products reviewed by auditors carried potentially misleading information, like incorrect dosages and health claims not authorized by Health Canada. Such unproven claims included that products relieved fatigue, enhanced endurance or burned fat.

The report found product label information was often printed so small that you would need a magnifying glass to read it, and some product labels said they were safe for children as young as three years old despite only being authorized for use by adolescents and adults.

“In my view, it’s not realistic for consumers to be able to just sift through all the information in the stores and internet and make their own decisions on safety and effectiveness,” said DeMarco. “Health Canada really needs to step up and protect consumers.”

A lack of funding has contributed to this widespread oversight, the report noted. Health Canada’s natural health product regulation is entirely funded by the public — unlike for over-the-counter-medications, there are no fees when applying for a licence.

Since 2004, Health Canada has issued more than 91,000 licences for natural health products.

The large volume of applications, combined with insufficient funding for regulatory activities, is a huge part of the problem, said Carmen Fletcher, vice-president of Quality and Compliance, a consulting group that works with clients to file product licence applications, including for natural health items.

As Health Canada works to implement the recommendations outlined in DeMarco’s report, he said consumers should be aware that many natural health products are mislabelled and improperly monitored.

Fletcher knows the ins and outs of natural health product regulation and said she is always very careful to read product labels. But tiny print and long ingredient lists can make that an overwhelming task for shoppers.

She said to check if a natural health product is licensed, look for an eight-digit authorized Natural Product Number (NPN) on the label.

“It provides a little bit of assurance that that has been looked at, there has been some oversight, and somebody has made the effort to understand the compliance requirements for this product,” said Fletcher. “That, to me, is probably the best thing a consumer could do.”

“Our department is already working to address all of the recommendations and is taking steps to accelerate its efforts to strengthen the natural health products program, including increased oversight of quality, advertising and labelling,” reads a statement from Health Canada released in response to the report.

“Health Canada has responded in a very positive manner to our recommendations,” said DeMarco. “In its responses, Health Canada clearly indicates its agreement with our recommendations and its interest in modernizing the regulatory framework for natural health products.”