Canada Cracked Down on Herb

While the debate continues to rage in the United States about the safety and regulation of ephedra, the Canadian government tackled the issue in January when health officials recalled hundreds of ephedra-based products, calling them “a serious risk to health.”

Canada allowed some previously approved over-the-counter cold remedies containing ephedrine, a synthetic form of ephedra, to remain on the market.

But regulators cracked down on many unapproved ephedra diet pills and energy boosters, many of which were imported from the United States and sold clandestinely at fitness centers, health food stores and other outlets.

Unlike the U.S., Canada requires any product, including dietary supplements, that claim a health benefit, to undergo the same regulatory process as a prescription drug; in other words, a product must be shown to be safe and effective before it can be sold.

“We consider ‘energy boosting’ to be a health claim,” says Ryan Baker, a spokesman for Health Canada, that country’s equivalent of the U.S. Food and Drug Administration.

“If a product is used to enhance metabolism, lose weight, increase energy or have a bodybuilding effect, then it’s a drug,” he says.

Initially, Health Canada issued a consumer warning about certain ephedra products in June 1997, motivated in part by the expectation that the FDA was planning to sharply curtail sale of preparations containing ephedra.

Even though the U.S. government subsequently backed off, “we continued to monitor the situation,” says Micheline Ho, a regulatory manager for Health Canada.

Growing reports of serious adverse side effects in Canada and the U.S., which ranged from dizziness and headaches to heart attacks and stroke, prompted Health Canada to issue another consumer alert in June 2001.

“We did look at what was happening worldwide, but other countries, like England and Australia, have tight controls on these products,” says Ho. “Only the U.S. was having similar problems.”

Following the June 2001 action, more unauthorized ephedra products showed up for sale in Canada. “There was an increase in serious adverse reactions, such as heart attacks and even deaths in young people who were using ephedra for weight loss,” says Ho, explaining why Health Canada pulled these products off the market earlier this year.