Natural Health Product Regulation

Walk into your local health food store and what do you see? Row upon row of bottles, tinctures, powders, and food supplements. But these ubiquitous products are more than the future wave of health care. To federal regulators, they represent a hot potato, a regulatory brouhaha in which everybody has an opinion.

Ever since Health Canada started to reregulate natural health products in the mid-1990s, speculation and accusations have abounded. During consultations, public talks and behind closed doors, people have asked, "Will I still be able to buy my favourite products? How will this impact the industry?" Almost a decade later, the same questions continue although the regulatory process has pushed forward.

Pre-90s laws classed natural health products as either foods or drugs, according to whether the manufacturer made health claims. At time of print, new regulations anticipated in summer of 2003 will have created a third category-somewhere between foods and drugs-within which these products lie. Manufacturers have to be licensed and supplements will be subject to greater scientific scrutiny-all of which must be detailed on more complete labels.

Some believe these changes are beneficial because they will give consumers more security and better quality, consistency, and efficacy of products. Others, however, feel the requirements will be tough, if not impossible, to handle, especially for smaller manufacturers and suppliers who don't have the same budgets as larger companies that can afford the increased costs.

Still others are not happy with the new regulations soon to appear in the Canada Gazette, Part II. They argue that natural health products are foods and shouldn't be hampered by the stricter rules that drugs require. To this end, Alliance party MP James Lunny (Nanaimo-Alberni) and his supporters have presented a private member's bill (C-420) that, if approved, would counteract the proposed regulations by placing natural health products in the food category. This move, critics point out, would come with its own set of drawbacks. For one, manufacturers may not be able to make product claims or give dosage recommendations.

The Canadian Health Food Association (CHFA), representing retailers and manufacturers, supports the proposed changes to the Food and Drugs Act. Says a recent bulletin, "The CHFA has been working closely with its members and the government to ensure that the regulations are appropriate and attainable by all stakeholders (small, medium, or large) who are committed to providing safe and effective quality products."

The CHFA acknowledges that some products may disappear if manufacturers can't or won't meet the research criteria or don't comply with proposed Good Manufacturing Practices. As well, increased product costs to consumers may result from higher expenses by manufacturers. (The results of a Health Canada business impact survey haven't been released at time of print.) However, on the positive side, the association says some products that have been pulled off the market, such as kava and melatonin, will reappear. Plus, new combination products will be available.

As to whether the new regulations will satisfy the diversity of critics is another question. Most likely, the answer is no. Throughout it all, however, what is not in doubt is the growth in natural product sales. Last year, the international nutraceutical market-including herbs, homeopathics, dietary supplements, and the like-was estimated at $46.7 billion US. Canada's share works out to be about three per cent, or $1.4 billion. With so much
at stake, another certainty exists: Consumers, retailers, manufacturers, and thousands of health food industry employees are watching and waiting to see where the chips fall.

Resources:
Canadian Health Food Association: chfa.ca.

Therapeutic Products Directorate:
hc-sc.gc.ca/hpfb-dgpsa/tpd dpt/aboutus_e.html.