He bases these views on previous studies showing that 50% of Canadians now use these products, along with the directorate's extensive consultations last year involving nearly 3000 people in 11 cities.

"We know we're headed in the right direction," says Waddington. A second draft of the NHPD's proposed regulations will be posted online for feedback this month and Waddington hopes to publish the regulations in the Canada Gazette by year's end. Manufacturers will then have about 2 years to comply.

The major questions for the scientific and medical communities concern the standard of evidence that will be used to assess the products. Waddington cautions that the proposed standards are still "very tentative" but promises that "safety will not be compromised."

For example, Waddington stresses that products such as Ripped Force (page 613) are not currently approved for sale in Canada and won't be under the NHPD. It and similar products are available in some stores and via the Internet and "we're trying to catch these products so they don't slip through."

The standard of evidence used to regulate these and other products will not be limited to clinical trials, which Waddington says "are not as necessary as you think they would be for proving efficacy." He says the NHPD also may look at anecdotal evidence and population studies.

Based on this evidence, health claims will be set for each product. There are 3 levels of claim: risk reduction, structure and function, and cure. The last category will require the same level of evidence — a double-blind, randomized clinical trial — as a prescription drug.

The directorate's Expert Advisory Committee, which includes 2 pharmacists, 3 physicians, 4 scientists and 5 complementary medicine practitioners, is already looking at developing monographs. The level of required testing — it will be done by NHPD employees — is still being debated. Laboratories and other resources will be shared when possible with the Therapeutic Products Program (TPP), which regulates prescription drugs.