In response to industry and consumer pressure, Health Canada has proposed new natural health products regulations that include product licensing, good manufacturing practices, improved labeling and enhanced research and public education efforts.

"Our goal is to ensure that Canadians have access to natural health products that are safe and of the highest quality," said Allan Rock, health minister. "These measures will help us achieve that goal."

The proposed regulations, open for public comment through the end of March, suggest that all natural health products must be properly licensed, packaged and labeled in accordance with the applicable requirements; and be manufactured, packaged, labeled and stored at a licensed site according to established good manufacturing practices. Health Canada, the Canadian government organization that most closely resembles the U.S. Food and Drug Administration, also will require the industry to report any adverse health reactions.

According to Health Canada, the new regulations would allow for better labeling to make it easier for consumers to make educated decisions when purchasing natural health products. New labels will include information about recommended use or purpose, recommended dose and duration of use, any cautions or contraindications, and the strength and potency of the medicinal ingredients.

"We're hoping this initiative will be recognized as an appropriate approach to product health claims and improved access to products that are useful to consumers," said Philip Waddington, N.D., directorate general of Health Canada's Office of Natural Health Products.

According to Health Canada, the new regulations would provide the natural health products industry with a clear set of regulatory guidelines specific to their products.

In the past, Canadian natural products with health claims were regulated as drugs; otherwise they fell under food regulations. The ONHP's 30-member staff consulted with industry experts to develop a front-end approach that ensures scientific evidence exists to support a product's health claim. ONHP has developed monographs on vitamins, minerals, botanicals and other supplements that will be expanded as research supports new health claims. The level of evidence will be proportionate to the level of the claim, meaning more scientific evidence will be required for a product that attempts to treat a disease than for a product that helps prevent disease.

"We looked at the U.S.'s Dietary Supplements Health and Education Act, but its claims are not adequately supported by evidence," Waddington said.

Still, the U.S. market obviously weighed on the government's decision to liberalize its markets. An estimated 40 percent of the products sold in the United States have not been allowed in Canada.

Although much of the feedback on the new regulations is positive, Waddington noted that there are concerns about what constitutes an appropriate good manufacturing practice and what are appropriate standards of evidence for scientific research.

"The world is watching Canada," said Kelley Fitzpatrick, president of Saskatchewan Nutraceutical Network. "We're trying to avoid the mistakes the United States made regarding quality issues, consumer education and media misinterpretation."

To comply with the new regulations, manufacturers, packagers, labelers, importers and distributors will have to be licensed. One prerequisite of licensure will be GMPs, which are outlined in the regulations. Health Canada will also require manufacturers to submit product information, including medicinal ingredients, source, potency, nonmedicinal ingredients and recommended use. Health Canada will issue authorized companies a product identification number. Retailers won't need licenses to sell natural health products.

Institut Rosell-Lallemand of Montreal, a supplier and manufacturer of probiotics will seek licensure of their site and hundreds of products, as well as develop new labeling and packaging. Donna Clements, Lallemand's regulatory affairs coordinator, is optimistic about the domestic market but expressed some concern about overseas export markets where probiotics are regulated more stringently as a pharmaceutical drug.

Health Canada says by meeting the regulatory requirements, companies will be better able to compete both domestically and internationally.

The ONHP has a $7 million budget for the next three years and an additional $3 million to fund natural health products research. Health Canada allotted $400,000 for specific research initiatives. They'll solicit community and consumer input on research priorities.

The proposed regulations can be found on Health Canada's Web site: www.hc-sc.gc.ca.

Sue Blanchard is senior editor of Functional Foods & Nutraceuticals. Dena Nishek is a freelance writer and editor.

Natural Foods Merchandiser volume XXIII/number 3/p. 40