Canadian NHP (Natural Health Products) Regulations

By Marilyn Zink

Natural Health Product regulations have been proposed (CHECK) by Health Canada that could have far reaching effects for manufacturers and consumers. These regulations come into effect on Jan. 1, 2004 with a transition period of two years for the licensing of manufacturing site and six years for product licensing. The regulations place requirements on people who manufacture, package, label, import or distribute Natural Health Products (NHPs).

But some manufacturers are worried the new legislation will threaten their business and remove access to natural health products.

“The fear is, if they do put the legislation in, we’re going to be up the creek,” says Peter Ferlow, of Ferlow Brothers products based in Mission. “The manufacturers believe there should be some sort of legislation to weed out those selling snake oil but the way the government’s doing it isn’t right. Specifically, herbal products should be in the food category, similar to (MP) James Lunney’s bill.” Lunney, MP for Nanaimo-Alberni, introduced private members Bill C-420 to amend the Foods & Drugs Act. The bill amends the old act and redefines dietary supplements, herbs, botanicals and other natural health products as foods and not drugs. The second reading of the bill is scheduled for Oct. 7,’03.

Manufacturers are concerned that the new legislation puts NHPs in the same category as drugs and will be considered as a subset under drug legislation. The legislation states that NHPs will need to have an NHP product licence (NPN) by the end of four years.

“If we make any sort of claim whatsoever, right away it goes into the drug category,” says Ferlow. “Basically, the manufacturers are put in the position of proving their innocence whereas the government assumes you’re guilty right away.”

Manufacturers are also concerned about the cost of putting the new legislation into effect. It’s expected this cost could result in higher product prices. “It’s good for consumers,” says Roy Kiss of Natural Balance. “It’s just a matter of what will the fees be for each application.”
He noted that a Drug Identification Number (DIN) costs $750 for each product (CHECK)
They have an organization called the Natural Health Coalition (naturalhealthcoalition.ca) to inform the public and publish a newsletter.

Some manufacturers are planning to challenge the new legislation in court. “Manufacturers are looking at legal action based on the Charter of Rights regarding freedom to choose how to eat and look after your body,” says Ferlow. An injunction application is being advanced by the combined efforts of Freedom of Choice in Health Care, and Friends of Freedom. This is set to happen Sept. 25. This injunction re-activates an injunction launched six years ago when a protest occured after proposed changes to the Food and Drugs Act. (The Herbal Collective magazine covered a rally in downtown Nanaimo on July 15, 1997). As a result, a Standing Committee on Health was struck and came up with 53 recommendations.

But the Natural Health Coalition charges that Health Canada and the Natural Health Products Directorate (created by Health Canada to oversee NHPs) did not follow any of those recommendations.

The coalition is concerned the proposed regulations maintain 100% power to 1, regulate any natural product as a drug 2, label any NHP as a prescription item 3, pull any existing product license and demand more safety information and 4, to cancel any such license if the information supplied is deemed to be inadequate. The coalition urges the public to act now to voice their concerns as they state the new regulations could eliminate 70-80% of existing small to medium size businesses and their products from the marketplace.

For more information, look up the following websites: www.naturalhealthcoalition.ca, www.hans.org (Health Action Network), www.friendsoffreedom.org, www.freedomofchoicecanada.org, www.jameslunneymp.ca, http://Canada.gc.ca/directories/direct_e.html (list of MPs), and www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html (Natural Health Products Directorate regulatons).