News Release
2003-47
June 18, 2003
For immediate release
Minister McLellan announces the adoption of new regulations for natural health products
OTTAWA - The Honourable Anne McLellan, Minister of Health, announced
the adoption of the Natural Health Products Regulations, which were published today
in Canada Gazette, Part II.
Previously, natural health products (NHPs) have been sold as either drugs or foods under
the Food and Drugs Act and Regulations, since there is no other category in which
they can be classified. The Natural Health Product Regulations are the result of a comprehensive
and inclusive consultation process with Canadian consumers, academics, health care practitioners
and industry stakeholders, and are a key element in fulfilling the House of Commons Standing
Committee on Health's 53 recommendations. The new Regulations call for improved labelling,
good manufacturing practices, product and site licensing, and provisions for a full range
of health claims that will be supported by evidence.
"Consumers have asked for labelling of all ingredients, for any warnings to be clear and
understandable, for assurances of quality and safety, and for a system of product licencing.
With the introduction of these Regulations, Canadians will now be in a much better position
to make more informed decisions about the natural health products they consume," stated
Minister McLellan.
The products that fall within the new Regulations include herbal remedies, homeopathic
medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential
fatty acids (such as Omega-3).
All natural health products in Canada will now require a product licence before being
marketed. Obtaining a license will require detailed information on the product submitted
to Health Canada, including medicinal ingredients, source, potency, non-medicinal ingredients
and recommended use. Once a product has been assessed by Health Canada, the product label
will bear a product licence number preceded by the distinct letters NPN, or, in the case
of a homeopathic medicine, by the letters DIN-HM. The product licence number on the label
will inform consumers that the product has been reviewed and approved by Health Canada
for safety and efficacy.
With improved, standardized labelling, consumers will be able to make more informed decisions
about the natural health products they buy. Labels will be required to specify directions
for use, the recommended use or purpose (health claim), medicinal and non-medicinal ingredients,
and any cautions, contra-indications or known adverse reactions associated with the product.
In making health claims, industry relies on a variety of standards of evidence, such as
history of use or traditional references, observational studies, expert committee reports
and clinical or trial data. However, ongoing research continues to be necessary. To address
this need for more research, Health Canada has committed $5 million over 5 years to create
the Natural Health Products Research Program. Funding for this program will be drawn from
the existing fiscal framework. The Natural Health Products Research Program has been developed
over the past 2 years through active dialogue with all relevant stakeholder groups. Working
closely in partnership with the community at large and the Canadian Institutes of Health
Research, the Natural Health Products Research Program will support the creation of a sustainable
national natural health product research presence, which meets the needs of Canadians.
There will be a transition period for the Regulations that will span from 2 to 6 years
- 2 years for site licensing and 6 years for products with drug identification numbers
(DINs)- to allow manufacturers, labellers, packagers, importers and distributors time to
meet the new requirements. During the phase-in period, Health Canada will provide support
to industry, and undertake a comprehensive public education and outreach program to ensure
that the Regulations are well understood. Health Canada is particularly mindful that much
of this industry consists of small and medium sized businesses and that a sustained effort
must be undertaken to provide working tools and processes to support these enterprises.
"Canadians have contributed significantly in the development of the Natural Health
Products Regulations, and will continue to be consulted as Health Canada moves forward
with their implementation," concluded the Minister.
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Media Inquiries:
Ryan Baker
Health Canada
(613) 954-4807
Farah Mohamed
Office of Anne McLellan
Federal Minister of Health
(613) 954-4807
Public Inquires:
(613) 957-2991
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