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Health Canada delays natural health product compliance rules

Health Canada delays natural health product compliance rules.
Wednesday, December 2nd, 2009 | 1:40 am
Canwest News Service

OTTAWA – Health Canada won't crack down on unlicensed natural health products for sale in Canada for at least another year, despite recent assurances that a new compliance plan would kick in soon.
The news, delivered privately to industry insiders at Health Canada workshops over the last two weeks, comes after Health Minister Leona Aglukkaq assured parliamentarians earlier this fall that the government was on track to clear a product licensing backlog by March 2010 and implement "a compliance strategy for 2010."
This means the current practice will be extended beyond March. Health Canada allows companies to sell unlicensed natural health products, provided they've submitted a product licence application with Health Canada's natural health product directorate and the department is not aware of any health risk associated with the product.
These products include teas, vitamins, mineral supplements, herbal products, exotic substances and several novel foods and drinks.
"They said, `Look, (March 2010) is an internal target deadline for the natural health product directorate to try and get through the backlog of applications. It is by no means, a firm compliance and enforcement date, that if you have don't have a natural product number by that date, we're going to start taking your products off the market or potentially charge you under the regulations or the act," Carl Carter, the director of regulatory affairs and policy development at the Canadian Health Food Association, said Tuesday.
During these recent briefings with industry players, Carter also said Health Canada officials made it clear enforcement actions will be pushed to 2011 while the department continues to work on developing a compliance policy.
"Based on the plan that they've articulated in those workshops, there will be activity regarding compliance and enforcement in 2010, but it's more in the continuing development of the policy rather than actually forcing product off the shelf or stopping product from being imported," said Carter.
He added, "We encourage Health Canada to do more to reach out to stakeholders because of this very, very serious concern that existed in people's mind about this looming enforcement."
The backlog and the related decision to grant enforcement amnesty to applicants dates back to 2004, when Health Canada created the directorate to process thousands of natural health product licence applications for a growing market.
In recent years, food companies have also contributed to the applications backlog by using this process as "workaround" to get novel foods and drinks with added vitamins or minerals to market with unapproved health claims.
For example, product licence applications currently awaiting approval include nearly 500 juice and water products, about 150 energy drinks and 25 candy products.
Overall, of all the product licence applications received since 2004, Health Canada says the directorate has completed or is in the process of completing about 70 per cent of applications.
In a statement, Health Canada played down any imminent change in practice.
"As has been our practice since 2004, Health Canada will continue to employ a risk-based compliance approach to unlicensed NHPs found on the market. Under this approach, products that present an unacceptable risk to health or do not have a licence application under review will be subject to compliance action."
A departmental spokesman also said Health Canada is presently working on the development of a revised compliance approach to be phased in through the fall of 2010. Keeping in mind "the current progress of the backlog," this new approach will "balance the need for mitigating risks without overly restricting access to natural health products that are safe and effective."
The natural health products file has been a difficult one for Health Canada since the directorate was created by the previous Liberal government.
Advocates complain Health Canada has stymied efforts of the industry to offer consumers safe natural health products. Critics say Health Canada validates bogus traditional-use claims which run contrary to scientific evidence.

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