National Post The National Association of Pharmacy Regulatory Authorities (NAPRA) says pharmacists cannot be assured the products are safe until they are granted a government licence

Makers of natural-health products say they are bracing for widespread layoffs and millions of dollars in losses after Canada’s pharmacy regulators issued a surprise directive recently urging druggists to stop selling unlicensed natural remedies.

The order affects thousands of herbal treatments, multi-vitamins and other products, most of them waiting for approval from Health Canada under a backlogged, five-year-old program to regulate natural-health goods.

The National Association of Pharmacy Regulatory Authorities (NAPRA) says pharmacists cannot be assured the products are safe until they are granted a government licence, and should not sell them in those circumstances. “Pharmacists are obliged to hold the health and safety of the public or patient as their first and foremost consideration,” said the association’s recently issued position statement.

Representatives of the natural health industry, however, have reacted angrily to the directive issued last month, predicting it will have little impact on patient safety, while triggering an economic “crisis” for their members.

“We are talking about job loss, we are talking about a lot of income loss, we are talking about product stuck in warehouses that cannot be sold,” Jean-Yves Dionne, a spokesman for the Canadian Health Food Association, said in an interview.

A statement issued by the association calls the directive self-serving and contrary to federal government policy.

“It has taken a sledge hammer to a finishing nail,” the group said. “It will create confusion for consumers. It is the wrong thing to do.”

NAPRA is comprised of representatives of the provincial colleges of pharmacy that regulate the profession. It is now up to the individual provinces to implement the statement. The Ontario and Quebec colleges have already done so, with Ontario pressing pharmacists to not buy or order any more of the affected products, and its neighbour pushing for druggists to also remove unlicensed product already on their shelves, Mr. Dionne said.

Pharmacies, as surprised by the directive as anyone, are caught in the middle, said Jeff Poston of the Canadian Pharmacists Association.

“One of the questions that everybody is asking in the pharmacy world is, ‘Why now?’ As far as people can determine, nothing has significantly changed.”

A spokesman for NAPRA was not available for comment.

The controversy revolves around Health Canada’s natural-health products regime, launched in 2004 to vet treatments that had been virtually unregulated before, in a new system some critics said was still too lax. As it ploughed through tens of thousands of applications for licences, the department said manufacturers could continue selling their products, so long as they had at least applied for approval.

The department has issued about 18,000 natural-health licences, while at least 10,000 products are still waiting for certification, industry representatives said. The whole process was supposed to be done by this January.

The natural-food association argues that it makes no sense for the pharmacy regulators to try to block sales of products awaiting licences, when Health Canada itself has said they can be sold pending an approval decision.

The industry is worth an estimated $1.5-billion to $2-billion a year, but many producers are small operations with sales of $1-million to $2-million annually and could be decimated by the directive, Mr. Dionne said. He cited a call he got last week from a manufacturer in Nova Scotia who sells two products — a homeopathic remedy for diabetes-related pain and a vitamin-based pill — that are waiting for approval and could be forced off the shelves.

“They are really panicking out there,” he said.

Some manufacturers could sell their products in health-food stores instead, but others rely exclusively on pharmacies, said Mr. Dionne.

Gerry Harrington of Consumer Health Products Canada, another industry group that represents natural-health producers, said his members strongly support the regulations. NAPRA may be targeting others, though, who are trying to evade any government oversight, he said.

“There is a sub-set of companies out there who have no intention of complying with the regulations, who have taken advantage of the interim approach to essentially ignore the regulations,” Mr. Harrington said. “Some companies have chosen … to lobby politically for an essentially unregulated or minimally regulated industry.”

Meanwhile, Mr. Poston said pharmacists are pressing for the regulators to lessen the disruption by phasing in the policy.