Feds eye changes to natural products rules
By Sheryl Ubelacker The Canadian PressNews
New round of public consultations starts this week
Health Canada is launching a second set of public consultations about a controversial plan to revamp regulations governing self-care products such as natural health remedies, cosmetics and over-the-counter medications.
Public meetings to gather consumer and industry input about the proposed changes begins April 4th in Saskatoon and continue in cities across the country for the next three months, said Manon Bombardier, director-general of the department’s Natural and Non-Prescription Health Products Directorate.
The Canada-wide consultation process follows a web-based gathering of opinion last fall that heard from more than 3,500 respondents, including consumers, industry representatives, health providers and public interest groups.
Much of the feedback was negative – with proponents of natural health products, in particular, expressing concerns over the suggested retooling – prompting Health Canada to develop “refined” proposals and take the consultation initiative on the road.
The proposed framework is meant to modernize the way self-care products and non-prescription drugs are regulated, Bombardier said, noting that some of the rules were first enacted decades ago.
“We want to ensure that Canadians continue to have access to a wide range of products that are safe and effective and can enter the market on a timely basis,” she said from Ottawa. “We want the evaluation or pre-market assessment to be based on risk.”
Self-care products considered moderate- or high-risk – such as a new non-prescription pain killer – would require a government review, based on science-based evidence that supports the manufacturer’s health claims.
Lower-risk products – including vitamins, homeopathic remedies and herbal medicines with a long history of use – would not be reviewed by Health Canada. However, they would no longer be able to make claims about prevention or treatment of a particular health condition, such as “relieves back pain.”
“Health Canada is of the view that self-care products in general are lower risk and therefore will not be treated (like) prescription drugs,” Bombardier said.
Currently, a product such as toothpaste may fall under three different categories and sets of regulations.
A flavoured product that just cleans the teeth is considered cosmetic, while one that contains fluoride would be regulated as a natural health product. But a toothpaste containing a whitener like hydrogen peroxide is classified as a drug and therefore subject to strict requirements to prove safety and effectiveness, including data from patient trials. Health Canada can recall such products if they are found not to meet those standards.
“So there are very different standards for very similar-looking products,” said Bombardier. “What we’re trying to do is make the system more consistent, more fair and more easy to understand for consumers, so that when they go shopping and have a variety of options in front of them, they can make an informed choice.”
The overhaul of self-care product regulations, put forward last fall, was met with opposition from many consumers, producers and retailers of natural health products, among them the Canadian Health Food Association (CHFA).
The trade association, which represents manufacturers, distributors and retailers of natural and organic health products, expressed concern that if adopted, the proposed changes would limit government oversight for some natural health products, reduce information on their labels and boost their cost. Some products might disappear from the market, while development of new products could be curtailed, the organization argued.
The organization is now taking a wait-and-see attitude, said CHFA president Helen Long.
“The initial proposal back in the fall lacked clarity and details, and we were concerned it could have negative implications for the 79 per cent of Canadians that are using natural health products,” Long said Friday.
“Once the next round of consultations actually begins, I expect that we we’ll get a bit more of a glimpse into where they’re proposing to go next.”
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