Regulations for natural health products in place by January

New federal regulations governing 50 000 over-the-counter (OTC) natural health products (NHPs) should be in place by January 2004. The regulations, which will cover everything from product labelling to adverse event reporting, have been under development since 1997. NHPs such as herbs, vitamins and probiotics currently fall under Health Canada's food or drug directorates. After January, all OTC NHPs will fall under the Natural Health Products Directorate (NHPD). By 2008, all NHPs will be licensed and assigned either a natural health or homeopathic products number.

“It feels like I wrote the final exam … and now we're going into the working world,” says Executive Director Phillip Waddington, a doctor of naturopathy. NHP sales totalled $4.3 billion in 2001.

One of the most controversial aspects of the regulations is the level of evidence required for licensing, which will depend on the manufacturer's claims. “As the claim becomes less defined, so does the risk,” Waddington told CMAJ.

Three types of claims will be allowed: effect on structure/function, effect on risk reduction, and use as a treatment/cure. A product claiming to treat or cure must undergo a randomized controlled trial (RCT), but Waddington says other claims can be supported by a range of evidence.

RCTs have long been considered the “gold standard” of medicine, and alternative and complementary products have come under fire for failing to meet the same standard. But Dr. David Moher of the Thomas C. Chalmers Centre for Systematic Reviews in Ottawa says there are already 5000 to 10 000 RCTs on these products worldwide. “To claim there is no hard evidence isn't useful — there is.”

The NHPD is compiling 300 “sample” monographs for commonly used products, such as St. John's wort. It will also establish a system for reporting adverse reactions. — Barbara Sibbald, CMAJ