www.cmaj.ca/cgi/content/full/170/6/941?etoc
www.cmaj.ca/cgi/reprint/170/6/941.pdf
The original articles have a nice picture of proposed labels.
SYNOPSIS
Complementary Medicine
Natural health products: New labels, new credibility?
Wayne Kondro
Ottawa
Bolstered consumer confidence and increased "credibility" for natural health
products are among anticipated outcomes of a new Canadian regime to oversee
the manufacture and sale of herbal, homeopathic and traditional remedies,
probiotics, amino acids and fatty acids.
Figure. New labels: more information, new promises. Photo by: Natural Health
Products Directorate
But critics say the regime is little more than "quackery" that will
inevitably lead to medical disaster.
Regulations that came into effect Jan. 1 govern the sale of an estimated 50
000 natural health products and will "ensure that Canadians can choose and
use natural health products with safety and confidence," says Phil
Waddington, director-general of Health Canada's Natural Health Products
Directorate.
"The regulations will give us a lot more credibility," adds Canadian Health
Food Association president Donna Herringer. "Consumers know that they've
been reviewed and approved before those health claims can be made."
Armed with an $8.6-million budget and a staff of 80, Waddington's
directorate is overseeing a regime that will require manufacturers to obtain
product licences for all their remedies (within 5 years for existing
products, and immediately for new ones). Manufacturers must also obtain site
licences for their production facilities, report adverse reactions, abide by
good manufacturing practices and meet labelling requirements.
The directorate will also produce a compendium of monographs to facilitate
licensing of existing and new products. Monographs have already been
developed for 40 products, including black horehound (variously used for
stomach, sleep and nervous disorders) and "Heal-All" (used for 28
conditions, including fever, diarrhea, "hemorrhagic affections," boils,
acne, backaches and to "strengthen the womb").
As many as 500 monographs will ultimately be developed, allowing industry to
license most new products by simple reference to the compendium. Only
complex new products that make broad therapeutic claims or resurrected
products once pulled from the market will be subject to human clinical
trials requirements.
The monographs are being developed by directorate staff and vetted by an
expert advisory committee chaired by retired Dalhousie pharmacy professor
Dr. Frank Chandler, using standards of evidence that include "traditional
use" and inclusion in "traditional references."
Critics say Health Canada hasn't raised the scientific bar anywhere near the
height it should be to ensure the efficacy and safety of these products.
"It's quackery," says Dr. Meera Thadani, assistant professor of pharmacy at
the University of Manitoba and a member of the Natural Health Products
Advisory Committee struck by Health Canada in 1997 to examine the need for
regulation in the area. "It's not scientific. Traditional use can mean that
my grandmother used it. But so what? Granny never kept track of things.
Thousands of years of use? Well, who was keeping track thousands of years
ago? The people who died using the product, that weren't saved by it, don't
have a voice in any of this."
Thadani fought against the inclusion of "traditional use" as valid
justification for therapeutic health claims, arguing that natural health
products should be subject to Food and Drug Act regulations, and that it
isn't valid to exempt industry from safety and efficacy proofs because of
expense. "So it's costly. Public safety is costly. You expect this of any
product that makes a therapeutic health claim."
But Herringer says such proofs would have been inappropriate. "The people in
the drugs directorate haven't got the sensitivity or the knowledge of how
applied natural health products are used and in what context they are used
as therapeutic drugs."
Moreover, she says traditional use is a valid measure of therapeutic
benefit. "The evidence is in the length of the use, that it did not cause
any harm."
Canadians for Rational Health Policy president Dr. Lloyd Oppel says it's
specious to argue that extended use necessarily yields efficacy or safety.
He contends that the new regime was created without proper scrutiny by the
scientific and medical community in the interests of making it easier for
industry "to make what essentially are health claims on the label, in order
to induce the public to buy them."
But Waddington, a naturopathic doctor, says the labelling requirements under
the new regime make it clear to consumers whether a "scientific" or
"traditional" therapeutic health claim is being made. For example, garlic
might be labelled 'traditionally used for treating colds and flu,' so that
the consumer knows that this is based on traditional evidence and not on new
studies that have been brought forward."- Wayne Kondro, Ottawa
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