Health Canada moves to liberalize, at least temporarily, the approval process by which natural health products come to market to assuage concerns about retailer liability.

The agency is expected this summer to implement the Natural Health Products Unprocessed Product License Applications Regulations, aimed at expediting the availability of NHPs - such as dietary supplements, homeopathics and personal care products - that might otherwise be tied up in Health Canada's backlogged licensing process.

After 180 days without receiving a licensing approval or rejection, an NHP application with the proper documentation and safety assurances would be granted an exemption number and could be sold at retail, under the UPLARs proposed in May.

"I'm actually surprised they went through with it, in terms of proposing these regulations," said Alice Tseng, a partner with the Toronto office of Blake, Cassels & Graydon.

"It's a big deal for a government to basically say, 'We have deemed a product to be licensed, even though we haven't reviewed the application from a substantive perspective,'" added Tseng, also a licensed pharmacist.

Since 2004, Canada has required NHPs to apply for natural health product numbers by submitting information on safety and efficacy, dosage recommendations and potential risks (¹ Also see "Lobbying Prompts Canadian Proposal To Distinguish Supplements From Drugs" - Pink Sheet, 23 June, 2008.). Novel products with specific health claims typically do not fit into Health Canada's "pre-cleared information" stream and require more comprehensive application packages.

However, a backlog of approvals since 2004 has forced the agency to allow some NHPs onto the market pending formal licensing and without NPNs. This elicited a January ² statement from Canada's National Association of Pharmacy Regulatory Authorities against the sale of unlicensed NHPs.

"Even though an argument can be made that an NHP or homeopathic product without a product license is not necessarily unsafe, the reverse is also true," said NAPRA, whose membership includes provincial and territorial pharmacy regulators.

"Pharmacists should not be placed in situations where they may be in a position to sell products that have not received approval for sale in Canada."

Reflecting NHP Market Reality

Maggie Graham, head of Health Canada's Risk Management Division, said the agency is in the process of revising its NHP compliance and enforcement policy in light of the breadth of products being submitted for approval.

"We're coming close to 30,000 products that will be licensed on the market, so we need a policy that actually reflects the reality of NHPs on the market," she said at the Drug Information Association annual meeting June 14 in Washington.

Graham said the proposed UPLARs are a necessary stopgap measure and the resulting exemption numbers on products would only be in effect for 30 months. She added the temporary process still will require NHP applicants to fit a minimum safety profile and not market to vulnerable populations.

A cost/benefit ³ analysis posted by Health Canada in May estimated the regulations could save up to $245 million in annual NHP sales that will otherwise be lost as many pharmacies cease sale of unlicensed products per NAPRA's position.

Tseng said the UPLARs appear favorable to both NHP manufacturers and retailers concerned about legal liability for the safety of unapproved products, though she said it remains unclear whether consumers will be able to distinguish between license numbers and exemption numbers on NHPs.

Food and drug attorney Martha Healey said the UPLARs represent a practical step toward giving unlicensed NHPs "a more concrete regulatory status."

Still, Healey, a partner with Ogilvy Renault in Ottawa, said she questions if the proposed regulations are "just going to be adding further administrative steps in advance of those products actually being able to" gain full-fledged licenses.

A Health Canada spokeswoman said by e-mail that the agency had completed 83 percent of the NHP licensing backlog as of June 16, and aims to give all remaining applications either an NPN or exemption number by year's end.

- Dan Schiff ( ⁴ d.schiff@elsevier.com )

Canada Proposes Temporary Expedited Approval For Natural Health Products

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