Canada- Rules Reshape Natural Health

[Guest guest]

[ A very intersting article...I'm a little confused as to how this fits in

with Codex.

Anyway, the good news for Canadians is that finally melatonin is now legal

to buy.]

 

Health Health Archives

Rules Reshape Natural Health

By helena bryan

Publish 20-May-2004

http://www.straight.com/content.cfm?id=2737

 

Customers face a boom in natural health products.

 

Ten years ago, Danielle Gallagher found a lump on the base of her neck.

Doctors, after doing a battery of tests on her thyroid to rule out cancer,

remained mystified.

 

" They had no clue, " Gallagher, now 36, told the Georgia Straight in a

telephone interview from her home in Gibsons. " All they said was it would

probably just go away. " Hardly a reassuring prognosis.

 

Gallagher did what many people do when they don't get answers from the

medical profession. She looked for alternatives and ended up in the care of

a naturopath who recommended she take iodine. Sure enough, the lump went

away. An informed and careful health consumer, Gallagher couldn't be sure

the disappearance wasn't a coincidence, but the experience reinforced her

commitment to self-care and consumer choice. Today, she uses alternative

remedies as a first line of defence against all kinds of ills, from colds

and flu to minor shock due to falls or cuts.

 

According to Health Canada, Gallagher is among the 50 percent of Canadians

who use some form of natural health product. The Nonprescription Drug

Manufacturers Association estimates that Canadians spent $375 million on

such remedies in 1996, the most recent figures available--and that was

before the explosive growth of the market in the late 1990s.

 

In 1997, Health Canada began a full public review of the framework

governing natural health products. After months of consultation involving

industry and professional associations, academics, and consumers, and amid

heated debate about the need to protect Canadians from harm versus their

right to make autonomous health-care decisions, the federal government put

into effect in January of this year new natural health­product regulations

under the auspices of the Natural Health Products Directorate. The Health

Canada agency, armed with $8.6 million annually and a staff of about 80,

was formed to oversee the manufacture and sale of herbal, homeopathic, and

traditional remedies. " The goal, " NHPD director general Phil Waddington

said over the phone from his Ottawa office, " is to ensure Canadians can

choose and use natural health products with safety and confidence. As

consumers we want access, but we also want to know these products are safe

and effective. We're trying to balance both sides. "

 

Under the new regulations, one popular product making a reappearance is

melatonin, a natural hormone typically used to counter jet lag. Health-food

stores were ordered by Health Canada to stop selling it in the mid '90s

because it was reclassified as a drug. Now it's listed among the natural

health products approved by the directorate, and places selling it have

Health Canada's endorsement as long as the label contains appropriate

warnings about possible side effects--such as headaches, daytime fatigue,

abdominal cramps, and irritability--and clear directions for use. According

to directorate guidelines, consumers should " not drive or use machinery for

five hours after taking melatonin " .

 

In the old system, natural health products were classified as either drugs

or food. If sold as drugs, they had to adhere to stringent criteria to earn

a drug identification number, allowing them to make certain health claims.

Products sold as food, on the other hand, weren't allowed to make any

health claims based on premarket testing; they also weren't required to

have warnings on their labels. Consequently, many of the tinctures and

remedies sold in health-food stores contained no information about proper

use or potential risks.

 

Under the new laws, there is a whole new classification for natural health

products--including vitamins and minerals, herbal remedies, and homeopathic

medicines, among others--designated by a natural-product number, or NPN.

Manufacturers of natural health products must now list all medicinal and

nonmedicinal ingredients and include complete information on how to use the

product and any known side effects.

 

The directorate is currently developing a list of about 500 " monographs " ,

or approved natural substances, to which manufacturers can refer when

formulating products. Already on the approved list is black horehound, a

remedy for stomach, sleep, and nervous disorders that some people also use

for a range of conditions from fever and acne to boils and backaches.

Consumers wanting to find out more about the new rules or check the status

of a natural health product can go to the Natural Health Productsate Web site at www.hc-sc.gc.ca/hpb/onhp/welcome_f.html/.

 

Those looking to register new, proprietary products must meet certain

standards of evidence, like clinical trials for ones that pose a

significant risk of harm, published studies, and traditional references.

The last category means that if a substance has been used within a culture

for at least 50 years, anecdotal evidence from the group's elders or

leaders is considered acceptable for inclusion.

 

Manufacturers also have to obtain licences, subject to quality controls,

hygiene procedures, and government inspections. Precision is a must. " If,

for example, you have two powdered ingredients side by side and you

inadvertently mix up the cough suppressant ephedra, which is a stimulant in

higher doses, with the echinacea, you're going to have consequences, "

Waddington said. Ephedra, especially when combined with other stimulants,

such as caffeine, has been linked to a host of adverse side effects, from

dizziness and decreased appetite to hypertension, stroke, and at least one

death.

 

Some of the opposition to the rules stemmed from concerns about the

influence of pharmaceutical companies. A 2001 editorial in the Canadian

Medical Association Journal criticized the NHPD's Expert Advisory

Committee, whose members, it claimed, are " agreeable to [industry]

stakeholders " and would " blunt the Directorate's milk teeth " .

 

In response to the criticism, Waddington said the consultation process was

thorough and involved other parties as well, including consumers,

retailers, and professional groups. " The pharmaceutical companies had

input, certainly, but they weren't driving the process. They weren't

sitting on the transition team and they're not on our current advisory

committee. "

 

The Canadian Health Food Association, which lobbied hard for the

regulations in the first place and which was actively involved in their

development, stands by them. " They ensure a level playing field, " said Anne

Wilkie, CHFA director of regulatory affairs and quality assurance, on the

line from her Toronto office. " Our products didn't fit under either a drug

or a food category. But we worked hard to set the bar to what we consider

are acceptable levels for safety and efficacy. "

 

During the consultation process and now through its Web site, however, a

self-proclaimed grassroots group called Freedom for Health has been

pressuring the federal government to scrap the regulations because they are

too rigorous.

 

Other opponents say the rules are not strict enough, among them Canadians

for Rational Health Policy, a lobby group headed by Vancouver doctor Lloyd

Oppel, who studies unorthodox therapies when he's not practising medicine.

The CRHP has particular concerns about the traditional-use reference. " We

are turning the clock back on scientific standards of evidence, " Oppel says

in a phone interview. " Tobacco is a poster child for this. A hundred years

ago it was promoted as a cure for cancer. I'm not saying we should out and

out ban natural health products, but to create a class of treatments that

give the public the impression they are safe is a mistake and may allow

disasters to happen. "

 

The aforementioned 2001 CMAJ editorial also questioned the stringency of

the regulations: " while penicillin will continue to be regulated by the

Therapeutic Products Programme, the nominally natural will be subjected to

a softer, gentler scrutiny, one that is not 'limited to double blind

clinical trials, but may also include other types of evidence such as

generally accepted and traditional references,' " it reads.

 

For Waddington, the criticism is simply an inevitable consequence of

change. " There's always going to be some who say new regulations are too

strict and some who say they're too lax. I believe we've struck a balance. "

 

Gallagher wasn't even aware the regulations were in effect. " But I've

always been cautious, " she said. " I never use something without checking

first to see whether you can take tons of it or whether it accumulates in

your system. And I never go overboard. "

 

She said she could see how the rules would benefit less cautious people.

" Without them, these remedies could be either dangerous or ineffective. "

Even informed consumers often don't know that the ubiquitous and friendly

garlic, for example, a common cold and flu remedy, is also a blood thinner

and not so benign when used with anti-inflammatory drugs. The new labels

will minimize the risks of such medicinal conflicts with appropriate warnings.

 

Whether the new regulations are cure or curse depends on who you talk to.

But one thing is clear: alternative remedies are here to stay, and so are

the rules governing them.