To understand today's status of natural health products (NHPs) in Canada, we have to look at their history. Those of us who have been HANS members since the early 80s will remember 1985, when hundreds of health products were taken off the market, including a number of amino acids and taheebo tea, to name a few.
At that time, the Health Canada's Health Protection Branch (HPB) expressed concern that natural products required quality control-so that the public could be sure that what was supposed to be in the bottle was actually in the bottle. Another concern, according to the HPB, was the validity of claims that individuals and businesses were making in relation to some of these products.
According to Health Canada's Schedule Section 3, "No person shall sell any food, drug, cosmetic, or device that is represented by a label, or that the person advertises to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A." Schedule A is a long list of conditions that are supposedly untreatable, including arthritis, asthma, cancer, depression, diabetes, gout, heart disease and obesity. So, if anyone offers prevention or treatment for these, they are, according to the Canadian Government, committing fraud. In other words, the government long ago decided that these conditions were incurable, by law, which means they control them. The government had also decided that NHPs needed to be sold as either foods, in which case they could not make any health claims, or as drugs, under the Canada Food and Drugs Act.
HANS members and many others staged several graphic rallies that year, to illustrate the disturbing logic being used by regulators for foods and drugs. Sure, call it quality control, or protecting the public. What it really seemed to be was the beginning of a turf war over who could prevent and treat Schedule A diseases.
HANS making tea-and history
One memorable HANS demonstration, a significant undertaking, was our Taheebo Tea Party, held at the Peace Arch Park crossing at Blaine, WA. Turn of the century costumes were rented for the several hundred peaceful, and colourful, protesters that loaded buses in Vancouver and arrived for the tea party and march, which was orchestrated by musicman AJ Parker. It was a noteworthy, international tea party, held in two countries at the same time, and it produced national media. We were commended for the entertaining way in which we portrayed our discontent.
Another colourful rally that year was held outside the downtown Vancouver offices of the Health Protection Branch. In that rally, which drew many hundreds, annoyed consumers and HANS members dressed up as fruits and vegetables.
I dressed up as a strawberry for that rally. A BCTV reporter came up to me and asked me why we were holding this rally. I took off the stem that was covering my head and said, "We just wanted to show, in a graphic way, that in our opinion, foods are not drugs." (Later that night, a friend of mine in Ottawa called and told me she had seen me on the news.)
Michael Bryan, President of HANS in 1985, wrote, "Once a substance has been declared a 'new drug' (what NHPs were called at the time), it cannot be sold to the public until the government is satisfied by laboratory and clinical evidence that it is 'safe and effective.' Such research runs into hundreds of thousands of dollars, and is only undertaken where there is financial incentive great enough to ensure recovery of research costs plus profit. That incentive is totally lacking in this case because it is impossible to obtain a patent on herbs and nutrients. You cannot patent herbaceous plants, fruits, and vegetables." Bryan continued, "The definition of 'new drug' suggests that the government can ban the sale of herbs and nutrients without any evidence whatsoever concerning their safety or therapeutic value.
"Considering that half of all prescription and over-the-counter drugs sold in Canada have never been tested for safety or efficacy [as reported the year before by Dr Ian Henderson, Director of the HPB's Bureau of Human Prescription Drugs], the recent re-classification of herbs and amino acids appears an arbitrary action," Byran concluded.
NHPs in the early 90s On December 19, 1992, Schedule 705 was poised to remove 64 herbs from the market, and reclassified them as drugs. These included Barberry Root, Common Wormwood, Feverfew, Goldenseal, Oregon Grape Root and St John's Wort. Keith Stelling of the Ontario Herbal Association said in 1993 in Health Action magazine, "There is general resentment at the HPB's actions because many of these herbs have been used safely for generations, and the HPB has not provided evidence of any threat to public safety, contrary to federally approved pharmaceutical drugs such as Halcion and Prozac. Indeed, (Frank) Welsh of the Food Regulatory Division admits that some herbs were pulled because there were claims being made that pertained to Schedule A diseases even though there is no evidence of toxicity."
HANS members were amongst the groundswell of consumer concern that precipitated the re-instatement of the Expert Advisory Committee on Herbs and Botanical Preparations (first introduced in 1985).
Beginning in 1997, HANS held four public forums, with up to 1,700 in attendance, on the regulation of NHPs, federally and internationally. In 1998, HANS staffer Cathrine Gabriel and I went to Ottawa to present HANS's 'Consumer First' submission to the Standing Committee on Health, suggesting that the needs of consumers, including their freedom to choose natural products and take care of themselves as they choose, be the first consideration, rather than corporate influence.
Because of concerns that consumers had not been heard, HANS invited the Standing Committee on Health to come to Vancouver and hear the views of Western Canadians. Thirty-five submissions were made to the committee.
NHPs in this decade
In 2005, HANS delegates went to Ottawa again, to make submissions on Bill C420, to amend the Food and Drugs Act to include Natural Health Products, and to amend the definition of drug to exclude food. Nevertheless, today, all NHPs marketed in Canada fall under the scope of the Natural Health Products Regulations.
Health Canada published the Natural Health Products Regulations in the Canada Gazette, Part II on June 18, 2003, and the regulations came into force January 1, 2004. The transition provisions for the Natural Health Product Regulations consider a staged approach over the six following years.
Natural Health Products (NHPs) are defined as the following:
- vitamins and minerals
- herbal remedies
- homeopathic medicines
- traditional medicines such as traditional Chinese medicines
- probiotics, and
- other products such as amino acids and essential fatty acids.
The manufacturers of NHPs have a clear set of strictly enforced guidelines to follow under the NHP Regulations. Regulations include proper manufacturing, labeling and identification. According to Health Canada, industry will benefit from having a clear set of regulations specific to natural health products NHPs, with reduced confusion regarding the applicable regulatory environment for NHPs and by increasing consumer confidence that the products they purchase are safe as the government regulates them. In addition, each NHP requires a product license to be sold.
According to some natural health advocates, these regulations from Health Canada are simply an effort to further control and restrict the NHP industry. Health activist and former President of the Canadian Health Food Association Croft Woodruff says, "Canada spends far too much of its time monitoring the natural products industry, which causes the least amount of problems for the consumer, compared to the pharmaceutical industry, which causes the greatest problems."
Time will tell how these regulations play out. There are already many seemingly unfair regulation side effects for manufacturers, retailers, and as a result, for consumers.
In coming editions of Health Action magazine, we will continue to uncover and report on what's happening to NHPs today.